Macular Degeneration: Kaiser PK

Kaiser PK, Anonymous00056, Boyer DS, Garcia R, Hao Y, Hughes MS, Jabbour NM, Kaiser PK, Mieler W, Slakter JS, Samuel M, Tolentino MJ, Roth D, Sheidow T, Strong HA. · Cole Eye Institute, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. · Ophthalmology. · Pubmed #19243834 No free full text.

Abstract: PURPOSE: To assess outcomes for patients with choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) treated with verteporfin photodynamic therapy (PDT) and bevacizumab. DESIGN: Retrospective, case series database study (registry). PARTICIPANTS: We included 1196 patients with CNV due to AMD who received > or =1 combination treatment of 1.25 mg intravitreal bevacizumab within 14 days of verteporfin PDT. METHODS: Retrospective analysis of baseline data with ongoing follow-up. Physicians from 45 clinical centers entered patient data at baseline and follow-up examinations, including subsequent treatments, into a secure, Web-accessed database. Snellen visual acuity (VA) was converted to logarithm of the minimum angle of resolution (logMAR) for statistical analyses. MAIN OUTCOME MEASURES: Change from baseline in VA and retreatment rates of any therapy after the initial combination treatment. RESULTS: Of 1196 patients, 1073 patients had > or =6 months of follow-up. For these 1073 patients, mean baseline VA was 0.967 logMAR (approximate Snellen 20/185) and 56.3% of patients (604/1073) were treatment naïve. After their baseline combination treatment, patients received a mean of 0.6 additional verteporfin PDT retreatments and 2.0 bevacizumab retreatments over a mean follow-up period of 15.0 months. By 12 months, 82% of patients (578/701) had stable or improved vision (loss of <3 lines or a gain in VA), 36% (255/701) improved by > or =3 lines, and 17% (121/701) improved by > or =6 lines. By 12 months, patients gained approximately 1.2 lines (6 letters) of VA from baseline. Patients who were treatment naïve gained significantly more VA by month 12 (+8.4 letters) compared with those who had been previously treated (+2.4 letters; P<0.01). Most serious adverse events (26/30) were judged by investigators as not related to any study treatment, although 3 ocular events were judged related to bevacizumab alone, and 1 ocular event was judged related to both bevacizumab and PDT. CONCLUSIONS: Combination therapy with PDT and bevacizumab led to vision benefit for most patients, particularly those who were treatment naïve at baseline. The number of retreatments was lower than published reports with either treatment delivered as monotherapy. Randomized clinical trials are underway to confirm these findings.

Sayanagi K, Sharma S, Yamamoto T, Kaiser PK. · Cole Eye Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA. · Ophthalmology. · Pubmed #19232732 No free full text.

Abstract: PURPOSE: To compare the ability to delineate and detect patterns of choroidal neovascularization (CNV) activity in patients with exudative age-related macular degeneration (AMD) after ranibizumab treatment between time-domain optical coherence tomography (TD-OCT) and 4 different spectral-domain optical coherence tomography (SD-OCT) devices. DESIGN: Prospective, consecutive case series. PARTICIPANTS: Sixty-one eyes of 58 patients with exudative AMD after ranibizumab treatment were included in this study. METHODS: All patients were imaged with TD-OCT and at least 1 of 4 different SD-OCT devices at the same visit after ranibizumab treatment. The OCT images were analyzed in a masked fashion by 2 independent graders (KS, TY) to delineate and detect the presence of CNV activity defined as the presence of subretinal fluid, intraretinal cysts, intraretinal fluid, sub-retinal pigment epithelium (sub-RPE) fluid, or a combination thereof. The automated evaluation of retinal thickness also was analyzed between devices. MAIN OUTCOME MEASURES: Evidence of CNV activity on linear B-scans and 3-dimensional so-called cube scans on SD-OCT and linear B-scan on TD-OCT. RESULTS: In linear B-scan mode, all 4 SD-OCT devices were superior in their ability to delineate sub-RPE fluid compared with TD-OCT (P<0.05). Three of 4 SD-OCT devices were superior in delineating intraretinal fluid, and 2 of 4 SD-OCT devices were superior in delineating subretinal fluid and intraretinal cysts (P<0.05). In the 3-dimensional so-called cube mode, all 4 SD-OCT devices were superior in detecting subretinal fluid and 2 of 4 SD-OCT devices were superior in detecting sub-RPE and intraretinal fluid (P<0.05). There were significant correlations in center point thickness between all SD-OCT devices and TD-OCT (P<0.01), and 3 of 4 and 1 of 3 SD-OCT devices showed significant differences from TD-OCT in center point thickness (P<0.01) and center subfield thickness (P<0.001), respectively. CONCLUSIONS: SD-OCT is superior to TD-OCT in evaluating for CNV activity in patients with wet AMD after ranibizumab injection. Retinal thickness measurements between SD-OCT and TD-OCT also were significantly different. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Browning DJ, Glassman AR, Aiello LP, Bressler NM, Bressler SB, Danis RP, Davis MD, Ferris FL, Huang SS, Kaiser PK, Kollman C, Sadda S, Scott IU, Qin H, Anonymous00193. · Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, FL 33647, USA. · Ophthalmology. · Pubmed #18675696 No free full text.

Abstract: OBJECTIVE: To evaluate optical coherence tomography (OCT) measurements and methods of analysis of OCT data in studies of diabetic macular edema (DME). DESIGN: Associations of pairs of OCT variables and results of 3 analysis methods using data from 2 studies of DME. PARTICIPANTS: Two hundred sixty-three subjects from a study of modified Early Treatment of Diabetic Retinopathy Study (mETDRS) versus modified macular grid (MMG) photocoagulation for DME and 96 subjects from a study of diurnal variation of DME. METHODS: Correlations were calculated for pairs of OCT variables at baseline and for changes in the variables over time. Distribution of OCT measurement changes, predictive factors for OCT measurement changes, and treatment group outcomes were compared when 3 measures of change in macular thickness were analyzed: absolute change in retinal thickness, relative change in retinal thickness, and relative change in retinal thickening. MAIN OUTCOME MEASURES: Concordance of results using different OCT variables and analysis methods. RESULTS: Center point thickness correlated highly with central subfield mean thickness (CSMT) at baseline (0.98-0.99). The distributions of changes in CSMT were approximately normally distributed for absolute change in retinal thickness and relative change in retinal thickness, but not for relative change in retinal thickening. Macular thinning in the mETDRS group was significantly greater than in the MMG group when absolute change in retinal thickness was used, but not when relative change in thickness and relative change in thickening were used. Relative change in macular thickening provides unstable data in eyes with mild degrees of baseline thickening, unlike the situation with absolute or relative change in retinal thickness. CONCLUSIONS: Central subfield mean thickness is the preferred OCT measurement for the central macula because of its higher reproducibility and correlation with other measurements of the central macula. Total macular volume may be preferred when the central macula is less important. Absolute change in retinal thickness is the preferred analysis method in studies involving eyes with mild macular thickening. Relative change in thickening may be preferable when retinal thickening is more severe.

Galor A, Margolis R, Brasil OM, Perez VL, Kaiser PK, Sears JE, Lowder CY, Smith SD. · Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, USA. · Ophthalmology. · Pubmed #17908594 No free full text.

Abstract: PURPOSE: To evaluate the rates of adverse ocular events after intravitreal triamcinolone acetonide (IVTA) injection in patients with and without uveitis. DESIGN: Retrospective observational case series. PARTICIPANTS: Two hundred twenty-two eyes of 173 patients were included in the study: 45 eyes of 31 patients with macular edema (ME) due to uveitis and 177 eyes of 142 patients with ME secondary to other etiologies. METHODS: Retrospective review of patients who received IVTA at the Cole Eye Institute for ME attributable to various causes between the years 2001 and 2005. Data review of clinical records included patient demographics, etiology of ME, and adverse outcomes after injection. Rates of adverse outcomes in patients with and without uveitis were compared. MAIN OUTCOME MEASURES: Intraocular pressure (IOP) elevation and posterior subcapsular cataract (PSC) progression. RESULTS: Uveitis patients were significantly younger, more likely to be female, and more likely to have had prior posterior sub-Tenon's capsule steroid injection and/or glaucoma therapy than their nonuveitis counterparts. In a multivariate analysis adjusting for the differences in these factors, the presence of uveitis was the strongest risk factor for an adverse IOP event (odds ratio, 2.5; 95% confidence interval [CI], 1.0-6.1; P = 0.05). The odds of having a documented increase in PSC after IVTA injection were 5.6 times greater in uveitis eyes (P = 0.007; 95% CI, 1.6-19.6). CONCLUSIONS: Intraocular pressure elevation and PSC progression occurred with greater frequency in uveitis patients receiving IVTA. Patients with uveitis treated with IVTA should be counseled about these risks and monitored closely.

Margolis R, Singh RP, Bhatnagar P, Kaiser PK. · Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. · Acta Ophthalmol. · Pubmed #17608830 No free full text.

Abstract: PURPOSE: To evaluate the effect of intravitreal injections of triamcinolone acetonide (IVTA) combined with panretinal photocoagulation (PRP) on visual acuity (VA) and foveal thickness in patients with concomitant high-risk proliferative diabetic retinopathy (PDR) and clinically significant macular oedema (CSMO). METHODS: This retrospective interventional case series included seven eyes diagnosed with both high-risk PDR and CSMO that underwent PRP and a single injection of 4 mg of IVTA. The main outcome measures were VA and foveal thickness, measured by optical coherence tomography (OCT) before treatment and throughout the follow-up period. RESULTS: Median follow-up was 301 days (range 180-715 days). Foveal thickness data were available for four of seven eyes. Before the combined treatment, median LogMAR (logarithm of the minimum angle of resolution) VA and median foveal thickness were 1 (Snellen 20/200, range 20/40-20/800) and 559 microm (range 333-689 microm), respectively. After treatment, median vision improved to LogMAR 0.544 (Snellen 20/70, range 20/40-20/1000) (P = 0.13). Vision improved or remained stable in six of seven eyes. Median foveal thickness at final follow-up was 436 microm (range 259-623 microm) (P = 0.15). Foveal thickness decreased or remained stable in all eyes. CONCLUSION: The addition of IVTA to PRP in the treatment of eyes with high-risk PDR and CSMO may prevent PRP-induced foveal thickening and loss of vision.

Taban M, Singh RP, Chung JY, Lowder CY, Perez VL, Kaiser PK. · Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. · Am J Ophthalmol. · Pubmed #17601427 No free full text.

Abstract: PURPOSE: To report an association between uveitis and sterile endophthalmitis after intravitreal triamcinolone acetonide injection. DESIGN: Retrospective case series. METHODS: A retrospective analysis of all patients receiving intravitreal triamcinolone injection at the Cole Eye Institute from January 2006 through September 2006 was carried out to evaluate for the occurrence of bacterial or sterile endophthalmitis. Indication for treatment, ocular history, best-corrected Snellen visual acuity, and clinical examination findings were recorded from the clinical charts before injection and at last follow-up. RESULTS: A total of 310 eyes received intravitreal triamcinolone injection for various causes, including age-related macular degeneration (AMD), diabetic retinopathy, vascular occlusion, and cystoid macular edema (CME) resulting from uveitis. There were no cases of culture-positive infectious endophthalmitis. There were six cases (1.9%) of sterile endophthalmitis. Of these six cases, four had prior history of uveitis, whereas only 20 of the 310 cases had a prior history of uveitis. All six patients sought treatment within three days of injection, and all recovered rapidly. Presenting visual acuity was either counting fingers or hand movements. Median best-corrected visual acuity before injection was 20/100(+), whereas median final visual acuity was 20/80(-). CONCLUSIONS: Patients with a history of uveitis may be at increased risk of experiencing sterile endophthalmitis resulting from intravitreal triamcinolone injection.

Margolis R, Lowder CY, Sears JE, Kaiser PK. · Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, OH 44195, USA. · Semin Ophthalmol. · Pubmed #17564933 No free full text.

Abstract: Systemic vasculitides can cause retinal vascular pathology, including cotton-wool spots, retinal hemorrhages, vascular occlusion, and capillary nonperfusion. Two main causes of visual decline include macular edema and retinal neovascularization. Presumably, both of these complications are caused by increased intraocular levels of vascular growth and permeability factors. We report a patient with occlusive retinal vasculitis associated with mixed connective tissue disease who was treated with intravitreal bevacizumab for chronic macular edema. One month after treatment, visual acuity improved from 20/80 to 20/60, and foveal thickness decreased from 543 microns to 306 microns. This effect persisted for at least 3 months after treatment. No complications, including increased retinal ischemia, were observed.

Chan CK, Meyer CH, Gross JG, Abraham P, Nuthi AS, Kokame GT, Lin SG, Rauser ME, Kaiser PK. · Southern California Desert Retina Consultants, Palm Springs, CA 92263, USA. · Retina. · Pubmed #17558314 No free full text.

Abstract: PURPOSE: To study retinal pigment epithelium (RPE) tears after off-label intravitreal bevacizumab (Avastin; Genentech, Inc., South San Francisco, CA) injection for neovascular age-related macular degeneration. Eyes with a vascularized pigment epithelial detachment (PED) that developed an RPE tear were compared with eyes with a vascularized PED but without an RPE tear. METHODS: Nine retina specialists across the United States and in Europe participated in this retrospective case series. All eyes that received intravitreal bevacizumab injection for choroidal neovascularization (CNV) over 12 months (October 2005 to September 2006) were included. Eyes without all three confirmed tests (fluorescein angiography, fundus photography, and optical coherence tomography) were excluded from analysis. Statistical analyses were performed on multiple characteristics of eyes with a vascularized PED that did and did not develop an RPE tear. RESULTS: Among 2,785 intravitreal bevacizumab injections for 1,064 eyes, RPE tears were found in 22 eyes in 22 patients (2.2%). A vascularized PED was present in 21 of 22 eyes that developed an RPE tear (17.1% of PED eyes; 15, 100% occult CNV; 6, predominantly occult CNV). Mean interval from bevacizumab injections to RPE tears was 37.3 days. Mean follow-up time was 124.9 days. Mean subfoveal PED size was larger for eyes with tears than for those without tears (13.97 mm vs 9.9 mm, respectively; P = 0.01; odds ratio, 1.09). There was substantially smaller mean ratio of CNV size to PED size for eyes with tears than for those without tears (27.9% vs 67.6%, respectively; P = 0.005). Mean pre-bevacizumab injection best-corrected Snellen visual acuity was 20/162, and mean post-RPE tear best-corrected visual acuity was 20/160 (P = 0.48). CONCLUSION: Large PED size is a predictor for RPE tears, and a small ratio of CNV size to PED size (<50%) is more common in eyes with RPE tears. Vision may be preserved despite RPE tears.

Ufret-Vincenty RL, Singh RP, Lowder CY, Kaiser PK. · Cleveland Clinic Cole Eye Institute, Cleveland, Ohio 44195, USA. · Am J Ophthalmol. · Pubmed #17258523 No free full text.

Abstract: PURPOSE: To report a case of cytomegalovirus (CMV) retinitis after placement of a fluocinolone acetonide (Retisert) implant. DESIGN: Interventional case report. METHODS: Retrospective chart review. RESULTS: A 65-year-old man with a history of Adamantiades-Behcet disease and bilateral recurrent uveitis that was unresponsive to systemic corticosteroid-sparing immunosuppressive therapy developed clinical evidence of CMV retinitis after receiving his second intravitreal Retisert implant in the left eye, while on no systemic immunosuppression. He did not develop CMV retinitis in the right eye despite multiple intraocular and periocular steroid injections. The patient responded well to intravitreal foscarnet followed by placement of an intravitreal ganciclovir implant. CONCLUSIONS: Ophthalmologists should be aware of the potential risk for development of CMV retinitis after local ocular immunosuppressive therapy.

Singh RP, Margolis R, Kaiser PK. · Digital Optical Coherence, Tomography Reading Center (DOCTR), 9500 Euclid Avenue, Cleveland, OH 44195, USA. · Br J Ophthalmol. · Pubmed #17229807 No free full text.

Abstract: OBJECTIVE: To evaluate the new surgical technique of cystoid macular oedema puncture (CMOP) in patients with longstanding cystoid macular oedema refractory to standard treatments. DESIGN: Interventional, retrospective case series METHODS: Retrospective review of patients with chronic cystoid macular oedema from vascular retinopathy for whom maximal medical or surgical treatment failed and who underwent pars plana vitrectomy and CMOP. Clinical findings, best-corrected Snellen visual acuity, stereo colour fundus photography, intravenous fluorescein angiograms, and optical coherence tomography were obtained before and after treatment to evaluate the efficacy and safety of the treatment. RESULTS: Seven patients were included in the study. Cystoid macular oedema was due to diabetic retinopathy in five patients, central retinal vein occlusion in one patient and branch retinal vein occlusion in one patient. Preoperative intravitreal steroids failed for all patients, and three patients also had focal grid photocoagulation. Previous pars plana vitrectomy, with elevation of the posterior hyaloid, internal limiting membrane peeling, and intravitreal steroid injection, had failed in three patients. The median time to CMOP was 488 days. Resolution or improvement of cystoid oedema occurred in all patients as determined by fluorescein angiography or optical coherence tomography, or both. However, visual acuity was unchanged in five patients, declined in one patient and stable in one patient. CONCLUSIONS: Although cystoid macular oedema does improve quantitatively after CMOP, the technique fails to improve visual acuity in patients.

Brasil OF, Smith SD, Galor A, Lowder CY, Sears JE, Kaiser PK. · The Cleveland Clinic, Cole Eye Institute, Cleveland, Ohio 44195, USA. · Br J Ophthalmol. · Pubmed #17108013 No free full text.

Abstract: AIM: To evaluate the predictive factors for visual outcome after intravitreal triamcinolone acetonide injection to treat refractory diabetic macular oedema (DME). METHODS: A retrospective chart review of patients with DME who met the following inclusion criteria was performed: clinically significant diabetic macular oedema, receipt of a 4 mg/0.1 ml intravitreal triamcinolone acetonide injection and an optical coherence tomography (OCT) of the macula performed up to 10 days before injection. All patients received a full ophthalmic examination including best-corrected Snellen visual acuity (VA). The main outcome measure was the mean change in vision 3 months after injection. RESULTS: Data from 73 eyes of 59 patients were analysed. After a mean follow-up of 324 days, the mean change in vision was -0.075 logarithm of minimum angle of resolution (logMAR) units, with 27.3% improving > or =3 lines, 6.8% declining > or =3 lines and 60.2% remaining stable within 1 line of baseline vision. Statistical analysis was performed using multivariate generalised estimating equations on the basis of data from 52 eyes of 42 patients. Factors associated with an improvement in vision 3 months after injection were worse baseline VA (-0.27 logMAR units/unit increase in baseline VA, p = 0.002) and presence of subretinal fluid (-0.17 logMAR units, p = 0.06). The presence of cystoid macular oedema negatively affected the visual outcome (0.15 logMAR units, p = 0.03). In addition, the presence of an epiretinal membrane (ERM) was associated with less visual improvement. ERM modified the effect of baseline VA as demonstrated by a significant interaction between these two variables (0.34 logMAR units/unit increase in baseline VA, p = 0.04). CONCLUSIONS: OCT factors and baseline VA can be useful in predicting the outcomes of VA 3 months after intravitreal triamcinolone acetonide injection in patients with refractory DME.

Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S, Anonymous00302. · Vitreoretinal Consultants, Methodist Hospital, Houston, TX 77030, USA. · N Engl J Med. · Pubmed #17021319 links to  free full text

Abstract: BACKGROUND: We compared ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--with photodynamic therapy with verteporfin in the treatment of predominantly classic neovascular age-related macular degeneration. METHODS: During the first year of this 2-year, multicenter, double-blind study, we randomly assigned patients in a 1:1:1 ratio to receive monthly intravitreal injections of ranibizumab (0.3 mg or 0.5 mg) plus sham verteporfin therapy or monthly sham injections plus active verteporfin therapy. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. RESULTS: Of the 423 patients enrolled, 94.3% of those given 0.3 mg of ranibizumab and 96.4% of those given 0.5 mg lost fewer than 15 letters, as compared with 64.3% of those in the verteporfin group (P<0.001 for each comparison). Visual acuity improved by 15 letters or more in 35.7% of the 0.3-mg group and 40.3% of the 0.5-mg group, as compared with 5.6% of the verteporfin group (P<0.001 for each comparison). Mean visual acuity increased by 8.5 letters in the 0.3-mg group and 11.3 letters in the 0.5-mg group, as compared with a decrease of 9.5 letters in the verteporfin group (P<0.001 for each comparison). Among 140 patients treated with 0.5 mg of ranibizumab, presumed endophthalmitis occurred in 2 patients (1.4%) and serious uveitis in 1 (0.7%). CONCLUSIONS: Ranibizumab was superior to verteporfin as intravitreal treatment of predominantly classic neovascular age-related macular degeneration, with low rates of serious ocular adverse events. Treatment improved visual acuity on average at 1 year. (ClinicalTrials.gov number, NCT00061594 [ClinicalTrials.gov].).

Kaiser PK. · Cleveland Clinic, Cleveland, OH, USA. · Am J Ophthalmol. · Pubmed #17011860 No free full text.

Abstract: PURPOSE: To provide an overview of angiogenesis and vascular endothelial growth factor (VEGF) and discusses the development approach, safety, and efficacy results of current and emerging anti-VEGF therapies for ocular diseases. DESIGN: Analysis of literature and current clinical trials of antiangiogenic agents for age-related macular degeneration (AMD). METHODS: Literature review. RESULTS: There are several novel antiangiogenic molecules that target vascular endothelial growth factor and are being used in the management of AMD. Large scale, Phase III trials have shown promising results in improving vision in this devastating disease. CONCLUSIONS: Therapies that target VEGF have shown tremendous promise as treatments for AMD.

Kim BY, Smith SD, Kaiser PK. · Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA. · Am J Ophthalmol. · Pubmed #16935584 No free full text.

Abstract: PURPOSE: To describe various morphologic patterns of diabetic macular edema (DME) demonstrated by optical coherence tomography (OCT) and correlate them with visual acuity. DESIGN: Retrospective, observational, case series. METHODS: A retrospective review of all patients with DME who underwent OCT evaluation and met the study inclusion criteria between May 1998 and December 2002 at the Cole Eye Institute was performed. The OCT scans were evaluated for the presence of diffuse retinal thickening (DRT), cystoid macular edema (CME), posterior hyaloidal traction (PHT), serous retinal detachment (SRD), and traction retinal detachment (TRD). Additionally, the retinal thickness was measured and visual acuity evaluated. RESULTS: Two hundred seventy-six OCT scans of 164 eyes of 119 patients were identified. OCT revealed five morphologic patterns of DME: DRT (269, 97%), CME (152, 55%), SRD without PHT (19, 7.0%), PHT without TRD (35, 12.7%), and PHT with TRD (8, 2.9%). Mean retinal thickness varied depending on the morphologic pattern. The mean visual acuities (Snellen equivalent) also varied between groups. Increasing retinal thickness in all patterns was significantly correlated with worse visual acuity (P < .005). The OCT patterns containing CME (P = .01) and PHT without TRD (P = .02) were also significantly associated with worse vision. CONCLUSIONS: DME exhibits at least five different morphologic patterns on OCT. There is a significant correlation between retinal thickness and visual acuity.

Kaiser PK, Anonymous00008. · Cole Eye Institute, The Cleveland Clinic Foundation, Cleveland, OH 44195, USA. · Graefes Arch Clin Exp Ophthalmol. · Pubmed #16538452 No free full text.

Abstract: PURPOSE: To report vision and safety outcomes up to 5 years from an extension of the Treatment of Age-related Macular Degeneration with Photodynamic Therapy (TAP) Investigation evaluating verteporfin therapy in patients with subfoveal choroidal neovascularization (CNV) in age-related macular degeneration. METHODS: Patients who completed the 2-year randomized, placebo-controlled portion of the TAP Investigation could participate in the open-label extension study for an additional 3 years. Patients in the study extension received open-label verteporfin therapy in the study eye, fellow eye or both eyes, irrespective of original treatment assignment to placebo or verteporfin, if leakage from CNV was evident on fluorescein angiography. Follow-up visits occurred at 3-month intervals through to month 48, with a final follow-up visit at month 60. RESULTS: Of the 402 verteporfin-treated patients in the randomized trials, 320 (80%) enrolled in the extension study; 193 (60%) of these completed the extension study up to 5 years. Patients received an average of approximately two treatments during the 3 years of the extension study. Seventy-seven (62%) of the 124 verteporfin-treated patients with predominantly classic lesions at baseline who enrolled in the extension completed the month 60 examination. Twenty-six (34%) of these 77 patients had lost 3 or more lines of visual acuity by month 24 and 27 (35%) had lost this amount of vision by month 60; the mean change in visual acuity from baseline was also similar at the month 24 and month 60 examinations (-1.5 and -1.6 lines, respectively). When visual acuity results were examined for all extension patients who received verteporfin at baseline, regardless of baseline lesion composition and extension study completion status, a similar pattern of visual acuity stabilization was evident. Few additional instances of infusion-related back pain or photosensitivity reactions were reported from month 24 to month 60. No additional safety issues were noted after bilateral treatment. CONCLUSIONS: Vision outcomes remained relatively stable from month 24 to month 60 even though the treatment rate was low during this period. The TAP Study Group identified no new safety concerns to preclude repeating verteporfin therapy as described in this study through 5 years.

Bakri SJ, Kaiser PK. · Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio 4195, USA. · Am J Ophthalmol. · Pubmed #15733990 No free full text.

Abstract: PURPOSE: To evaluate posterior subtenon injection of triamcinolone acetonide for refractory diabetic macular edema (DME). DESIGN: Retrospective, interventional, case series. METHODS: SETTING: Clinical practice. PATIENT POPULATION: Patients with persistent clinically significant DME involving the center of the fovea 3 or more months after one or more treatments of focal macular photocoagulation were included. Exclusion criteria were a history of corticosteroid-responsive intraocular pressure (IOP) rise, intraocular surgery within 3 months, and any laser treatment within 1 month. PROCEDURE: All patients received an ophthalmic history and examination including best-corrected Snellen visual acuity, IOP measurement, anterior segment examination including evaluation of lens status with LOCS II criteria, dilated fundus examination, and a posterior subtenon injection of 40 mg triamcinolone acetonide at baseline. Patients were reevaluated at 1, 3, 6, and 12 months after injection. RESULTS: Seventy-three injections were performed in 63 eyes of 50 patients. The mean baseline visual acuity was 20/80. Mean visual acuity significantly improved to 20/50 at 1 month, then stabilized to 20/65 at 3 months, 20/68 at 6 months, and 20/63 at 12 months. Complications were rare, with a transient significant rise in intraocular pressure at the 3-month evaluation and ptosis in two patients. CONCLUSIONS: Visual acuities remained stable or improved over a 12-month period after posterior subtenon triamcinolone injections for refractory DME. There was a statistically significant improvement in visual acuity at 1 month.

Cahill MT, Kaiser PK, Sears JE, Fekrat S. · Duke University Eye Center, Erwin Road, PO Box 3802, Durham, NC 27710, USA. · Br J Ophthalmol. · Pubmed #14609825 links to  free full text

Abstract: BACKGROUND: Arteriovenous (AV) sheathotomy, a potential treatment for branch retinal vein occlusion (BVO), surgically separates retinal vessels at an AV crossing. Relief of the aetiological obstruction, with resolution of cystoid macular oedema (CMO), may result in improved visual acuity. METHODS: A retrospective review of consecutive cases of AV sheathotomy for BVO was undertaken. Eyes were categorised as having resolution (group 1), reduction (group 2), or persistence (group 3) of CMO. Intergroup comparisons were made with regard to preoperative, intraoperative, and postoperative parameters. Preoperative and postoperative visual acuities were compared within each group. RESULTS: Of the 27 eyes identified, eight (29.6%) had resolution, 14 (51.8%) had reduction, and five (18.6%) had persistence of CMO. Median preoperative visual acuity was similar in all groups (1.0, 1.0, 1.3, respectively; p = 0.29). Overall median follow up was 12.0 months (Q1 = 12.0, Q2 = 22.5). Eyes in group 1 had significantly better median postoperative visual acuity than eyes in groups 2 and 3 (0.6, 1.0, 2.0 respectively; p = 0.01). A significantly higher proportion of eyes in group 1 had visual acuity improvement compared with eyes in the other groups (87.5% v 35.7% and 20.0%; p = 0.03). Median postoperative visual acuity was significantly better than median preoperative visual acuity in group 1 eyes only (p = 0.02). A higher percentage of group 1 eyes had evidence of postoperative retinal perfusion (83.0% v 21.43% and 40.0%; p = 0.16). Postoperative retinal detachment occurred in three eyes (11.1%). CONCLUSION: Complete resolution of CMO after AV sheathotomy occurred in one third of patients, and postoperative vision improved significantly in this group. However, in the majority of cases, despite an improvement in CMO, there was no improvement in vision after AV sheathotomy.

Moshfeghi DM, Kaiser PK, Grossniklaus HE, Sternberg P, Sears JE, Johnson MW, Ratliff N, Branco A, Blumenkranz MS, Lewis H. · Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. · Am J Ophthalmol. · Pubmed #12614752 No free full text.

Abstract: PURPOSE: To report the clinicopathologic findings after submacular removal of choroidal neovascular membranes (CNV) treated with verteporfin ocular photodynamic therapy. DESIGN: Interventional case series. METHODS: Retrospective review of eight eyes of eight patients who underwent submacular surgery for CNV after having previously received verteporfin ocular photodynamic therapy for presumed ocular histoplasmosis (one patient), age-related macular degeneration ([AMD] three patients) pathologic myopia (two patients), punctate inner choroiditis (one patient), and idiopathic CNV (one patient). All cases had undergone ocular photodynamic therapy with verteporfin using standard protocols. Six of eight patients suffered a submacular hemorrhage after ocular photodynamic therapy, and two of eight patients refused further ocular photodynamic therapy. All patients subsequently had submacular surgery with removal of the CNV. One membrane was routinely processed, sectioned, and stained with hematoxylin and eosin. Five membranes were stained with toluidine blue for light microscopic examination. Semithin (1.0 microm) sections were cut and stained with uranyl acetate-lead citrate for transmission electron microscopy. RESULTS: Choroidal neovascular membranes were removed at 3 days (presumed ocular histoplasmosis), 29 days (punctate inner choroiditis), 63 days (AMD, pathologic myopia), 66 days (AMD), 107 days (pathologic myopia), 116 days (AMD), and 152 days (idiopathic) after verteporfin ocular photodynamic therapy. Histopathologic and ultrastructural examination showed areas of vascular occlusion at 3 days that were not seen at later time points. All specimens had patent CNV. There were signs of vascular damage with extravasated erythrocytes and fibrin, pigment clumping in cells, and inflammatory cells in all but the 3-day specimen.CONCLUSIONS: This case series presents data only from patients who refused repeat treatment with ocular photodynamic therapy or who developed submacular hemorrhage after initial photodynamic therapy. Histopathologic evaluation of CNV 3 days after verteporfin ocular photodynamic therapy showed partial vascular occlusion that was not present in later specimens. These later specimens demonstrated evidence of vascular damage. Verteporfin ocular photodynamic therapy does not appear to lead to permanent and complete occlusion of the CNV. Thus, treatments that lead to permanent closure of CNV without damage to the retinal pigment epithelium and sensory retina are still needed.

Moshfeghi DM, Lowder CY, Roth DB, Kaiser PK. · Cole Eye Institute, The Cleveland Clinic Foundation, Ohio 44195, USA. · Am J Ophthalmol. · Pubmed #12095826 No free full text.

Abstract: PURPOSE: To report a case of retinal and choroidal vascular occlusion occurring as a complication after posterior sub-Tenon triamcinolone injection for treatment of uveitic cystoid macular edema. DESIGN: Interventional case report. METHODS: Retrospective study. A 32-year-old woman with uveitis and cystoid macular edema underwent a right posterior sub-Tenon injection of triamcinolone (40 mg/ml, 1 ml total) through a superotemporal approach after topical anesthesia. After the procedure, the patient experienced severe eye pain, orbital ecchymosis, and globe proptosis consistent with retrobulbar hemorrhage. RESULTS: Dilated fundus examination of the right eye (OD) demonstrated multiple intraretinal hemorrhages with particulate white emboli occluding the retinal and choroidal vessels. Visual acuity was no light perception. Ocular massage and hypotensive therapy was initiated for an intraocular pressure of 50 mm Hg. Canthotomy and cantholysis were performed. A total of 39 months post-incident, her visual acuity improved to 20/100. CONCLUSION: Posterior sub-Tenon triamcinolone injection can rarely result in retinal and choroidal occlusion. Immediate intervention may preserve limited visual acuity.

Kaiser PK, Riemann CD, Sears JE, Lewis H. · Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA. · Am J Ophthalmol. · Pubmed #11162978 No free full text.

Abstract: PURPOSE: To review the clinical, photographic, fluorescein angiographic, and optical coherence tomographic findings in patients with the diabetic macular traction and edema (DMTE) associated with posterior hyaloidal traction (PHT). METHODS: We performed a prospective review of nine eyes of nine patients with diabetic macular edema (DME) and PHT on clinical examination. The patients had a comprehensive ophthalmic history and examination, color photographs, fluorescein angiography, and optical coherence tomography (OCT). RESULTS: All patients had diabetic retinopathy and DME. Of the nine eyes, eight patients had previous focal or grid photocoagulation. All nine eyes had a thickened, taut, glistening posterior hyaloid on clinical biomicroscopic examination with no posterior vitreous separation. Fluorescein angiography was performed on seven eyes, and all had early hyperfluorescence with deep, diffuse, late leakage in the macular area consistent with DMTE associated with PHT. Optical coherence tomography scans of the macular region revealed retinal thickening in all eyes with a mean retinal thickness of 556.9 +/- 114.7 microns. In addition, eight of the nine eyes had a shallow macular traction detachment associated with PHT. CONCLUSION: Eyes with DME associated with PHT may have a shallow, subclinical, macular detachment. Optical coherence tomography may be useful in evaluating patients with DME to see if a macular detachment is present.

Lewis H, Kaiser PK, Lewis S, Estafanous M. · Cole Eye Institute and the Division of Ophthalmology, The Cleveland Clinic Foundation, Ohio 44195, USA. · Am J Ophthalmol. · Pubmed #10458168 No free full text.

Abstract: PURPOSE: To conduct a prospective study of macular translocation in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. METHODS: In 10 eyes of 10 patients with subfoveal choroidal neovascularization and best-corrected visual acuity ranging from 20/50 to 20/800 (median, 20/111), the fovea was relocated by means of scleral imbrication, intentional retinal detachment with small posterior retinotomies, and partial fluid-air exchange. In two eyes, the choroidal neovascular membranes were removed at the time of macular translocation; in seven eyes they were photocoagulated in the postoperative period; and in one eye the membrane was removed during reoperation to unfold a macular fold. RESULTS: All 10 eyes were followed up for 6 months. The median postoperative foveal displacement was 1286 microm (range, 114 to 1,919 microm). In three eyes (30%), a foveal fold formed postoperatively requiring reoperation, with one of these eyes requiring a second reoperation for a rhegmatogenous retinal detachment. Best-corrected visual acuity improved in four eyes (median, 10.5 letters) and decreased in six eyes (median, 14.5 letters). The median change in visual acuity was a decrease of 5 letters. The final best-corrected visual acuity was 20/80 in two eyes, 20/126 in one eye, 20/160 in four eyes, 20/200 in one eye, 20/250 in one eye, and 20/640 in one eye. CONCLUSIONS: Our initial experience with limited macular translocation suggests that this surgical technique is unpredictable. However, in patients with subfoveal choroidal neovascularization from age-related macular degeneration, it offers the potential for improving visual function and may be associated with less loss of vision than the disease itself, if allowed to progress. Further refinements in surgical indications and technique are needed to make this procedure safer, more predictable, and more beneficial.

Estafanous MF, Lowder CY, Kaiser PK. · No affiliation provided · Ophthalmology. · Pubmed #15691581 No free full text.

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