Macular Degeneration: Heier JS

Comer GM, Ciulla TA, Heier JS, Criswell MH. · Indiana University School of Medicine, Department of Ophthalmology, 702 Rotary Circle, Indianapolis, IN 46202, USA. · Expert Opin Emerg Drugs. · Pubmed #15757408 No free full text.

Abstract: Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in the industrialised world. Within the past decade, researchers have introduced many promising prevention and treatment options in an attempt to minimise the central vision loss imparted from AMD. Based on large-scale, randomised, prospective, placebo-controlled trials, a specially formulated combination of the antioxidants vitamin C, vitamin E, beta-carotene, copper and zinc is the only proven means of AMD prophylaxis. Thermal laser photocoagulation and photodynamic therapy with verteporfin are the only standard treatment options. However, efficacy is limited and treatment is only applicable to a minority of AMD patients. Thus, alternative pharmacological interventions are in all phases of clinical development. Researchers are guardedly optimistic that these advances may change the entire approach to AMD management in the near future. This review article will detail the currently accepted treatment options, as well as describe several of the more promising investigational pharmacological approaches to AMD.

Kim RW, Heier JS. · Ophthalmic Consultants of Boston, MA 02114, USA. · Int Ophthalmol Clin. · Pubmed #15577563 No free full text.

This publication has no abstract.

Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T, Anonymous00115. · Vitreoretinal Consultants, Methodist Hospital, Houston, Texas 77030, USA. · Ophthalmology. · Pubmed #19118696 No free full text.

Abstract: OBJECTIVE: The 2-year, phase III trial designated Anti-vascular endothelial growth factor (VEGF) Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization (CNV) in Age-related Macular Degeneration (ANCHOR) compared ranibizumab with verteporfin photodynamic therapy (PDT) in treating predominantly classic CNV. DESIGN: Multicenter, international, randomized, double-masked, active-treatment-controlled clinical trial. PARTICIPANTS: Patients with predominantly classic, subfoveal CNV not previously treated with PDT or antiangiogenic drugs. INTERVENTION: Patients were randomized 1:1:1 to verteporfin PDT plus monthly sham intraocular injection or to sham verteporfin PDT plus monthly intravitreal ranibizumab (0.3 mg or 0.5 mg) injection. The need for PDT (active or sham) retreatment was evaluated every 3 months using fluorescein angiography (FA). MAIN OUTCOME MEASURES: The primary, intent-to-treat efficacy analysis was at 12 months, with continued measurements to month 24. Key measures included the percentage losing <15 letters from baseline visual acuity (VA) score (month 12 primary efficacy outcome measure), percentage gaining >or=15 letters from baseline, and mean change over time in VA score and FA-assessed lesion characteristics. Adverse events were monitored. RESULTS: Of 423 patients (143 PDT, 140 each in the 2 ranibizumab groups), the majority (>or=77% in each group) completed the 2-year study. Consistent with results at month 12, at month 24 the VA benefit from ranibizumab was statistically significant (P<0.0001 vs. PDT) and clinically meaningful: 89.9% to 90.0% of ranibizumab-treated patients had lost <15 letters from baseline (vs. 65.7% of PDT patients); 34% to 41.0% had gained >or=15 letters (vs. 6.3% of PDT group); and, on average, VA was improved from baseline by 8.1 to 10.7 letters (vs. a mean decline of 9.8 letters in PDT group). Changes in lesion anatomic characteristics on FA also favored ranibizumab (all comparisons P<0.0001 vs. PDT). Overall, there was no imbalance among groups in rates of serious ocular and nonocular adverse events. In the pooled ranibizumab groups, 3 of 277 (1.1%) patients developed presumed endophthalmitis in the study eye (rate per injection = 3/5921 [0.05%]). CONCLUSIONS: In this 2-year study, ranibizumab provided greater clinical benefit than verteporfin PDT in patients with age-related macular degeneration with new-onset, predominantly classic CNV. Rates of serious adverse events were low. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Heier JS, Boyer DS, Ciulla TA, Ferrone PJ, Jumper JM, Gentile RC, Kotlovker D, Chung CY, Kim RY, Anonymous00353. · Ophthalmic Consultants of Boston, Boston, MA 02114, USA. · Arch Ophthalmol. · Pubmed #17101999 links to  free full text

Abstract: OBJECTIVE: To investigate the safety and efficacy of intravitreal ranibizumab treatment combined with verteporfin photodynamic therapy (PDT) in patients with predominantly classic choroidal neovascularization secondary to age-related macular degeneration. METHODS: In this 2-year, phase I/II, multicenter, randomized, single-masked, controlled study, patients received monthly ranibizumab (0.5 mg) (n = 106) or sham (n = 56) injections. The PDT was performed 7 days before initial ranibizumab or sham treatment and then quarterly as needed. MAIN OUTCOMES MEASURES: Proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months (primary efficacy outcome) and the incidence and severity of adverse events. RESULTS: At 12 months, 90.5% of the ranibizumab-treated patients and 67.9% of the control patients had lost fewer than 15 letters (P<.001). The most frequent ranibizumab-associated serious ocular adverse events were intraocular inflammation (11.4%) and endophthalmitis (1.9%; 4.8% if including presumed cases). On average, patients with serious inflammation had better visual acuity outcomes at 12 months than did controls. Key serious nonocular adverse events included myocardial infarctions in the PDT-alone group (3.6%) and cerebrovascular accidents in the ranibizumab-treated group (3.8%). CONCLUSION/APPLICATION TO CLINICAL PRACTICE: Ranibizumab + PDT was more efficacious than PDT alone for treating neovascular age-related macular degeneration. Although ranibizumab treatment increased the risk of serious intraocular inflammation, affected patients, on average, still experienced visual acuity benefit.

Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY, Anonymous00301. · Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, FL 33136, USA. · N Engl J Med. · Pubmed #17021318 links to  free full text

Abstract: BACKGROUND: Ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--has been evaluated for the treatment of neovascular age-related macular degeneration. METHODS: In this multicenter, 2-year, double-blind, sham-controlled study, we randomly assigned patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization to receive 24 monthly intravitreal injections of ranibizumab (either 0.3 mg or 0.5 mg) or sham injections. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. RESULTS: We enrolled 716 patients in the study. At 12 months, 94.5% of the group given 0.3 mg of ranibizumab and 94.6% of those given 0.5 mg lost fewer than 15 letters, as compared with 62.2% of patients receiving sham injections (P<0.001 for both comparisons). Visual acuity improved by 15 or more letters in 24.8% of the 0.3-mg group and 33.8% of the 0.5-mg group, as compared with 5.0% of the sham-injection group (P<0.001 for both doses). Mean increases in visual acuity were 6.5 letters in the 0.3-mg group and 7.2 letters in the 0.5-mg group, as compared with a decrease of 10.4 letters in the sham-injection group (P<0.001 for both comparisons). The benefit in visual acuity was maintained at 24 months. During 24 months, presumed endophthalmitis was identified in five patients (1.0%) and serious uveitis in six patients (1.3%) given ranibizumab. CONCLUSIONS: Intravitreal administration of ranibizumab for 2 years prevented vision loss and improved mean visual acuity, with low rates of serious adverse events, in patients with minimally classic or occult (with no classic lesions) choroidal neovascularization secondary to age-related macular degeneration. (ClinicalTrials.gov number, NCT00056836 [ClinicalTrials.gov].).

Rosenfeld PJ, Heier JS, Hantsbarger G, Shams N. · Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami, Miami, Florida 33136, USA. · Ophthalmology. · Pubmed #16581423 No free full text.

Abstract: PURPOSE: To investigate whether multiple intravitreal doses of up to 2 mg of an antigen-binding fragment known as ranibizumab, derived from a humanized anti-vascular endothelial growth factor antibody, can be tolerated and are biologically active when injected using a dose-escalating strategy in eyes of patients with neovascular age-related macular degeneration (AMD). DESIGN: Open-label, 2-center, uncontrolled, randomized clinical study of 3 different dose-escalating regimens of ranibizumab. PARTICIPANTS: Thirty-two patients with primary or recurrent subfoveal choroidal neovascularization secondary to AMD were enrolled. Baseline best-corrected visual acuity (VA) in the study eye was from 20/40 to 20/640 (Snellen equivalent). METHODS: Treatment regimens consisted of 5, 7, or 9 intravitreal injections of ranibizumab at 2- or 4-week intervals for 16 weeks, with escalating doses ranging from 0.3 to 2.0 mg. Patients were evaluated through day 140, 4 weeks after their last injection. MAIN OUTCOME MEASURES: Safety was assessed based on ocular and nonocular adverse events, changes in VA, changes in intraocular pressure (IOP), slit-lamp ocular examination, changes in lesion characteristics based on fluorescein angiography and color fundus photography, and the presence of anti-ranibizumab antibodies. RESULTS: Twenty-nine patients received an injection at baseline, and 27 patients completed the study through day 140. Results were similar across the 3 treatment groups. All patients experienced ocular adverse events, most of which were mild. The most common ocular adverse events were iridocyclitis (83%) and injection-site reactions (72%). Inflammation did not increase with repeated injections, despite the increasing ranibizumab doses. Transient mild IOP elevations were common after ranibizumab injection. No serum anti-ranibizumab antibodies were detected. Overall, median and mean VAs in the study eyes improved by day 140 in all 3 groups. Only 3 of the 27 patients lost significant vision. There was no significant lesion growth, and a decrease in area of leakage from choroidal neovascularization was detected through day 140. CONCLUSIONS: Multiple intravitreal injections of ranibizumab at escalating doses ranging from 0.3 to 2.0 mg were well tolerated and biologically active in eyes with neovascular AMD through 20 weeks. Mild transient ocular inflammation was the most common postinjection adverse event.

Heier JS, Antoszyk AN, Pavan PR, Leff SR, Rosenfeld PJ, Ciulla TA, Dreyer RF, Gentile RC, Sy JP, Hantsbarger G, Shams N. · Ophthalmic Consultants of Boston, Boston, Massachusetts 02114, USA. · Ophthalmology. · Pubmed #16483659 No free full text.

Abstract: OBJECTIVE: To assess safety of repeated intravitreal injections of ranibizumab in treating neovascular age-related macular degeneration (AMD), and to assess changes in visual acuity (VA) and AMD lesion characteristics. DESIGN: Multicenter, controlled, open-label, clinical trial. PARTICIPANTS: Sixty-four patients with subfoveal predominantly or minimally classic AMD-related choroidal neovascularization. METHODS: In part 1, subjects were randomized to monthly intravitreal ranibizumab for 3 months (4 injections of 0.3 mg or 1 injection of 0.3 mg followed by 3 injections of 0.5 mg; n = 53) or usual care (UC; n = 11). In part 2, subjects could continue their regimen for 3 additional months or cross over to the alternative treatment. MAIN OUTCOME MEASURES: Adverse events (AEs), intraocular pressure (IOP), VA, and lesion characteristics assessed by fluorescein angiography and fundus photography. RESULTS: Of the 64 randomized subjects, 62 completed the 6-month study. Twenty of 25 subjects (80%) randomized to 0.3 mg, and 22 of 28 subjects (79%) randomized to 0.5-mg ranibizumab in part 1 continued on that treatment in part 2; 9 of 11 (82%) subjects randomized to UC in part 1 crossed over to ranibizumab treatment in part 2. The most common AEs with ranibizumab were reversible inflammation and minor injection-site hemorrhages. Serious AEs were iridocyclitis, endophthalmitis, and central retinal vein occlusion (1 subject each). Postinjection, IOP increased transiently in 22.6% of ranibizumab-treated eyes in parts 1 and 2. After 4 ranibizumab injections (day 98), mean (+/- standard deviation) VA had increased 9.4+/-13.3 and 9.1+/-17.2 letters in the 0.3- and 0.5-mg groups, respectively, but had decreased 5.1+/-9.6 letters with UC. In part 2 (day 210), VA increased from baseline 12.8+/-14.7 and 15.0+/-14.2 letters in subjects continuing on 0.3 and 0.5 mg, respectively. Visual acuity improved from baseline > or =15 letters in 26% (day 98) and 45% (day 210) of subjects initially randomized to and continuing on ranibizumab, respectively, and areas of leakage and subretinal fluid decreased. No UC subject had a > or =15-letter improvement at day 98. CONCLUSIONS: Repeated intravitreal injections of ranibizumab had a good safety profile and were associated with improved VA and decreased leakage from choroidal neovascularization in subjects with neovascular AMD.

Heier JS, Topping TM, Baumann W, Dirks MS, Chern S. · Ophthalmic Consultants of Boston, Boston, Massachusetts, USA. · Ophthalmology. · Pubmed #11054327 No free full text.

Abstract: OBJECTIVE: To evaluate the efficacy of ketorolac tromethamine 0.5% ophthalmic solution, prednisolone acetate 1.0% ophthalmic solution, and ketorolac and prednisolone combination therapy in the treatment of acute, visually significant, cystoid macular edema (CME) occurring after cataract extraction surgery. DESIGN: Randomized, double-masked, prospective trial. PARTICIPANTS: Twenty-eight patients who had undergone cataract extraction and in whom clinical CME developed within 21 to 90 days after cataract surgery. METHODS: Patients were randomized to topical therapy with ketorolac (group K), prednisolone (group P), or ketorolac and prednisolone combination therapy (group C) four times daily. Treatment was continued until CME resolved or for 3 months, whichever occurred first. Treatment was then tapered over 3 weeks. Examinations were monthly and included Snellen visual acuity, contrast sensitivity, Amsler grid, slit-lamp examination, dilated fundus examination, and fluorescein angiography. RESULTS: Twenty-six of 28 patients completed the study. Patients were enrolled an average of 48 days after surgery. The average improvements in Snellen visual acuity were as follows: 1.6 lines in group K, 1.1 lines in group P, and 3.8 lines in group C. This reached statistical significance for all visits when group C was compared with group P, and for visits 4 and 5 when group C was compared with group K. Group C reached a mean change of two lines or more by visit 2; at no time did either group K or P reach a mean two-line improvement. At no time was a significant difference detected between group K and P with regard to visual acuity or change from baseline. A two-line or more improvement in Snellen acuity was achieved in 16 of 26 patients (61%). Analysis by group revealed four of eight patients (50%) in group P, six of nine patients (67%) in group K, and eight of nine patients (89%) in group C who had achieved a two-line or more improvement. In patients who did improve two lines or more, improvement occurred an average of 2.75 months after initiating therapy in group P, 1.43 months in group K, and 1.33 months in group C. Improvements in contrast sensitivity and leakage on fluorescein angiography tended to mirror improvements in Snellen acuity. CONCLUSIONS: Treatment of acute, visually significant pseudophakic CME with ketorolac and prednisolone combination therapy appears to offer benefits over monotherapy with either agent alone. Patients were more likely to experience recovery of two lines or more of visual acuity. Patients treated with combination therapy or ketorolac monotherapy responded more quickly than did patients treated with prednisolone alone.

Heier JS. · Ophthalmic Consultants of Boston, Boston, Massachusetts 02114, USA. · Retina. · Pubmed #19553799 No free full text.

Abstract: Control of choroid neovascularization may be important but insufficient to preserve long-term vision threatened by age-related macular degeneration. A retrospective analysis of patients who were early participants in anti-vascular endothelial growth factor studies, other pathologic processes, particularly fibrosis and atrophy, have participated in vision loss independent of new vessel growth. The recent interest in combination treatment strategies has been dominated by more effective blockade of angiogenic signaling, but it may also be necessary to incorporate therapies that block fibrosis, inhibit atrophy or other pathophysiologic processes not directly related to neovascularization to achieve the ultimate goal of preserving sight for a long term.

Hudson HL, Stulting RD, Heier JS, Lane SS, Chang DF, Singerman LJ, Bradford CA, Leonard RE, Anonymous00049. · Retina Centers, P.C., Tucson, Arizona, USA. · Am J Ophthalmol. · Pubmed #18760765 No free full text.

Abstract: PURPOSE: To evaluate long-term safety and best-corrected visual acuity (BCVA) results of a telescope prosthesis in patients with end-stage age-related macular degeneration (AMD). DESIGN: Prospective, open-label clinical trial with fellow-eye controls. METHODS: Patients with end-stage AMD (bilateral geographic atrophy or disciform scars; BCVA, 20/80 to 20/800) received the telescope prosthesis at 28 centers. Methods were similar to those described in the one-year results, with follow-up visits continuing at 18 and 24 months. Main outcome measures included BCVA change from baseline, endothelial cell density (ECD) and morphometry, and incidence of complications. RESULTS: At two years, data from 174 (92.6%) of 188 available patients were analyzed. Overall, 103 (59.5%) of 173 telescope-implanted eyes gained three lines or more (doubling of visual angle) of BCVA compared with 18 (10.3%) of 174 fellow control eyes (P < .0001). Mean BCVA improved 3.6 lines (standard deviation [SD], 1.9 lines) and 2.8 lines (SD, 2.3 lines) from baseline in eyes with the 3X and 2.2X device models, respectively. Mean ECD stabilized through two years, with 2.4% mean cell loss occurring from one to two years. There was no significant change in coefficient of variation or percentage of hexagonal endothelial cells from within six months to two years after surgery. The most common complication was inflammatory deposits. CONCLUSIONS: Long-term results of this telescope prosthesis show the substantial BCVA improvement at one year is maintained at two years. Key indicators of corneal health demonstrate ECD change that reflects remodeling of the endothelium associated with the implantation procedure. ECD stabilizes over time, and there is no evidence of any ongoing endothelial trauma.

Subramanian ML, Heier JS, Esrick E, Devaiah AK, Topping TM, Frederick AR, Morley MG. · Ophthalmic Consultants of Boston, USA. · Ophthalmic Surg Lasers Imaging. · Pubmed #17152539 No free full text.

Abstract: BACKGROUND AND OBJECTIVE: To determine the visual outcome of laser treatments for macular edema due to branch retinal vein occlusion (BRVO) in patients with a preoperative visual acuity (VA) of 20/200 or worse compared to patients with a preoperative VA of better than 20/200. PATIENTS AND METHODS: Records of 88 patients with macular edema secondary to BRVO undergoing laser treatment from 1984 to 2003 were reviewed. Mean VA was measured before and after each treatment and after the final treatment. RESULTS: All patients received between one and five laser treatments. Preoperative VA was better than 20/200 in 56 patients (group 1) and 20/200 or worse in 32 patients (group 2). Patients in group 1 had a mean improvement of 0.48 lines and 57% had a final VA of 20/40 or better. Patients in group 2 had a mean improvement of 1.69 lines and 20% had a final VA of 20/40 or better. CONCLUSIONS: Patients with poor VA (20/200 or worse) secondary to macular edema due to BRVO responded positively to laser treatment. The level of preoperative VA can be a useful predictor of visual outcome. These patients should consider laser treatment before alternative, more aggressive approaches.

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].).

Chun DW, Heier JS, Topping TM, Duker JS, Bankert JM. · Ophthalmic Consultants of Boston, Boston, Massachusetts 02114, USA. · Ophthalmology. · Pubmed #17011952 No free full text.

Abstract: OBJECTIVE: To evaluate the biologic activity of multiple intravitreal injections of ranibizumab in patients with center-involving clinically significant diabetic macular edema (DME) and to report any associated adverse events. DESIGN: Single-center, open-label, dose-escalating pilot study. PARTICIPANTS: A total of 10 eyes of 10 patients (mean age, 69.3 years [range, 59-81]) with DME involving the center of the macula and best-corrected visual acuity (BCVA) in the study eye between 20/63 and 20/400. INTERVENTION: Three intravitreal injections of ranibizumab (0.3 mg or 0.5 mg each injection) administered on day 0, month 1, and month 2, and observation until month 24. MAIN OUTCOME MEASURES: Primary end points were the frequency and severity of ocular and systemic adverse events. Secondary end points were BCVA and measurement of retinal thickness by optical coherence tomography. RESULTS: Of the 10 patients enrolled, 5 received 0.3-mg and 5 received 0.5-mg ranibizumab. Intravitreal injections of ranibizumab were well tolerated. No systemic adverse events were reported. Five occurrences of mild to moderate ocular inflammation were reported. At month 3, 4 of 10 patients gained > or =15 letters, 5 of 10 gained > or =10 letters, and 8 of 10 gained > or =1 letters. At month 3, the mean decrease in retinal thickness of the center point of the central subfield was 45.3+/-196.3 microm for the low-dose group and 197.8+/-85.9 microm for the high-dose group. CONCLUSIONS: Ranibizumab appears to be a well-tolerated therapy for patients with DME. This pilot study demonstrates that ranibizumab therapy has the potential to maintain or improve BCVA and reduce retinal thickness in patients with center-involved clinically significant DME.

Hudson HL, Lane SS, Heier JS, Stulting RD, Singerman L, Lichter PR, Sternberg P, Chang DF, Anonymous00087. · Retina Centers, Tucson, Arizona, USA. · Ophthalmology. · Pubmed #16989902 No free full text.

Abstract: PURPOSE: To evaluate the safety and efficacy of an implantable visual prosthetic device (IMT; VisionCare Ophthalmic Technologies, Saratoga, CA) in patients with bilateral, end-stage age-related macular degeneration (AMD). DESIGN: Prospective, open-label, multicenter clinical trial with fellow eye controls. PARTICIPANTS: A total of 217 patients (mean age, 76 years) with AMD and moderate to profound bilateral central visual acuity loss (20/80-20/800) resulting from bilateral untreatable geographic atrophy, disciform scars, or both were enrolled. METHODS: A visual prosthetic device (implantable telescope), designed to enlarge retinal images of the central visual field, was implanted monocularly in the capsular bag after lens extraction. Fellow eyes were not implanted to provide peripheral vision and served as controls. Study patients participated in 6 visual rehabilitation visits after surgery. MAIN OUTCOME MEASURES: Best-corrected distance visual acuity (BCDVA) and best-corrected near visual acuity (BCNVA), quality-of-life scores from the National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) and the Activities of Daily Life scale, endothelial cell density (ECD), and incidence of complications and adverse events. RESULTS: At 1 year, 67% of implanted eyes achieved a 3-line or more improvement in BCDVA versus 13% of fellow eye controls (P<0.0001). Fifty-three percent of implanted eyes achieved a 3-line or more improvement in both BCDVA and BCNVA versus 10% of fellow eyes (P<0.0001). Mean BCDVA and BCNVA improved 3.5 lines and 3.2 lines, respectively, in implanted eyes versus 0.8 lines and 1.8 lines, respectively, in fellow eyes (P<0.0001). Change in visual acuity was not related to lesion type. Mean NEI VFQ-25 scores improved by more than 7 points from baseline (P<0.01) on 7 of 8 relevant subscales. Eleven eyes did not receive the device because of an aborted procedure. Endothelial cell density was reduced by 20% at 3 months and 25% at 1 year. The decrease in ECD was correlated with postsurgical edema (P<0.0001), and there was no evidence that endothelial cell loss is accelerated by ongoing endothelial trauma after implantation. CONCLUSIONS: This implantable visual prosthesis can improve visual acuity and quality of life in patients with moderate to profound visual impairment caused by bilateral, end-stage AMD.

Chun DW, Heier JS, Raizman MB. · Ophthalmic Consultants of Boston, Tufts -- New England Eye Center, 50 Staniford Street, Suite 600, Boston, MA 02114, USA. · Expert Rev Med Devices. · Pubmed #16293092 No free full text.

Abstract: Age-related macular degeneration is the leading cause of blindness in the USA. For the 1.8 million patients in the most advanced stages, there are currently no available treatments to improve vision. A visual prosthetic device that provides one eye with an enlarged retinal image of the central visual field has been developed with the goal of improving central vision in patients with bilateral end-stage macular degeneration. The other eye is left unimplanted to provide peripheral vision. This device is designed for implantation in the posterior chamber of the eye during an outpatient surgical procedure. In US Food and Drug Administration clinical trials, 72% of patients experienced an improvement in their level of visual impairment (profound or severe, to severe or moderate). This was accompanied by a clinically significant improvement in quality of life.

Alster Y, Bressler NM, Bressler SB, Brimacombe JA, Crompton RM, Duh YJ, Gabel VP, Heier JS, Ip MS, Loewenstein A, Packo KH, Stur M, Toaff T, Anonymous00244. · Clin Reg Consulting Services Inc., Irvine, California, USA. · Ophthalmology. · Pubmed #16154198 No free full text.

Abstract: PURPOSE: To assess the ability of the Preferential Hyperacuity Perimeter (PreView PHP; Carl Zeiss Meditec, Dublin, CA) to detect recent-onset choroidal neovascularization (CNV) resulting from age-related macular degeneration (AMD) and to differentiate it from an intermediate stage of AMD. DESIGN: Prospective, comparative, concurrent, nonrandomized, multicenter study. PARTICIPANTS: Eligible participants' study eyes had a corrected visual acuity of 20/160 or better and either untreated CNV from AMD diagnosed within the last 60 days or an intermediate stage of AMD. METHODS: After obtaining consent, visual acuity with habitual correction, masked PHP testing, stereoscopic color fundus photography, and fluorescein angiography were performed. Photographs and angiograms were evaluated by graders masked to diagnosis and PHP results. The reading center's diagnosis determined if the patient was categorized as having intermediate AMD or neovascular AMD. MAIN OUTCOME MEASURES: A successful study outcome was defined a priori as a sensitivity of at least 80% and a specificity of at least 80%. RESULTS: Of 185 patients who gave consent to be enrolled, 11 (6%) had PHP results judged to be unreliable. An additional 52 were not included because they did not meet all eligibility criteria. Of the remaining 122 patients, 57 had an intermediate stage of AMD and 65 had neovascular AMD. The sensitivity to detect newly diagnosed CNV using PHP testing was 82% (95% confidence interval [CI], 70%-90%). The specificity to differentiate newly diagnosed CNV from the intermediate stage of AMD using PHP testing was 88% (95% CI, 76%-95%). CONCLUSIONS: Preferential Hyperacuity Perimeter testing can detect recent-onset CNV resulting from AMD and can differentiate it from an intermediate stage of AMD with high sensitivity and specificity. These data suggest that monitoring with PHP should detect most cases of CNV of recent onset with few false-positive results at a stage when treatment usually would be beneficial. Thus, this monitoring should be considered in the management of the intermediate stage of AMD.

Esrick E, Subramanian ML, Heier JS, Devaiah AK, Topping TM, Frederick AR, Morley MG. · Ophthalmic Consultants of Boston, Boston, Massachusetts 02114, USA. · Am J Ophthalmol. · Pubmed #15808160 No free full text.

Abstract: PURPOSE: To report the visual outcome of multiple laser treatments for macular edema attributable to branch retinal vein occlusions (BRVO) and to determine if any prognostic factors exist for improvement. DESIGN: Retrospective chart review. METHODS: A private practice with four vitreoretinal surgeons performed laser treatments on 88 eyes of 88 patients with macular edema secondary to BRVO from 1984 to 2003. Mean preoperative and postoperative visual acuities were collected after each laser treatment. Final visual acuities were also documented. RESULTS: All 88 patients received at least one laser treatment, and 46 patients of the initial 88 underwent multiple treatments. Overall, forty-one (46.6%) of the total 88 patients improved by 2 or more lines, whereas 33 patients (37.5%) were within 1 line of the preoperative vision, and 14 patients (15.9%) worsened by 2 or more lines. The mean final visual improvement was 0.92 lines for all 88 patients. The group of patients that responded favorably to the first laser treatment (n = 37) showed an overall improvement of 3.5 lines. However, patients who responded poorly to the first laser treatment resulted in an overall worsening of vision by 0.96 lines. CONCLUSIONS: Our study found that multiple laser treatments can improve visual acuity and resolve macular edema and that each additional laser treatment gives a patient a modest chance of visual improvement. A positive or stable visual response to first laser treatment portends a favorable prognosis with subsequent laser treatments.