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Review Optical coherence tomography versus stereoscopic fundus photography or biomicroscopy for diagnosing diabetic macular edema: a systematic review. free! 2007
Virgili G, Menchini F, Dimastrogiovanni AF, Rapizzi E, Menchini U, Bandello F, Chiodini RG. · Department of Ophthalmology, University of Florence, Florence, Italy. · Invest Ophthalmol Vis Sci. · Pubmed #17962446 links to free full text
Abstract: PURPOSE: To review systematically the sensitivity and specificity of optical coherence tomography (OCT) for diagnosing macular edema attributable to diabetic retinopathy compared with well-established gold standard tests such as fundus stereophotography or contact and noncontact fundus biomicroscopy. METHODS: Medline and Embase were searched electronically and six major ophthalmic journals from 1998 to 2006 were hand searched. Two reviewers independently assessed trial searches, studied quality with the QUADAS (Quality Assessment of Diagnostic Accuracy Studies) checklist, and extracted data. The target disease was clinically significant macular edema (CSME) according to Early Treatment of Diabetic Retinopathy Study (ETDRS) criteria. A bivariate model was used to obtain summary estimates of sensitivity and specificity and fit a summary receiver operating characteristic (ROC) curve. RESULTS: Fifteen studies were considered eligible. These studies were of good quality for most items of the QUADAS checklist, but most studies did not report masking of examiners and did not describe how withdrawals and undetermined results were treated. Seven studies included healthy control subjects, which could have artificially enhanced OCT diagnostic performance. All but one study included both eyes of the patients without taking into account the within-subject correlation in statistical analyses. Sensitivity and specificity data could be extracted from only 6 of 15 studies, because appropriate cross tabulations of index and reference tests were not reported by the others. In five of these studies, central retinal thickness cutoffs between 230 and 300 microm were adopted to define abnormal OCT results and considered the central type of CSME only, whereas in one study a complex algorithm accounting for extrafoveal CSME was used. The design of one study was case-control and was excluded from the meta-analysis. The expected operating point on the summary ROC, a pooled estimate of all studies, corresponded to a sensitivity of 0.79 (95% CI: 0.71-0.86), a specificity of 0.88 (95% CI: 0.80-0.93), a positive likelihood ratio of 6.5 (95% CI: 4.0-10.7), and a negative likelihood ratio of 0.24 (95% CI: 0.17-0.32). These values suggest a good overall performance of OCT for diagnosing CSME. CONCLUSIONS: OCT performs well compared with fundus stereophotography or biomicroscopy to diagnose diabetic macular edema. The quality of reporting of such studies should be improved, and authors should present cross tabulations of index and reference test results. Data adjusted for within-subject correlation should also be provided, although this issue represents a challenge for systematic reviewers.
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Review New therapies for neovascular age-related macular degeneration: critical appraisal of the current evidence. 2007
Virgili G, Do DV, Bressler NM, Menchini U. · Department of Oto-Neuro-Ophthalmological Surgical Sciences, University of Florence, Florence, Italy. · Acta Ophthalmol Scand. · Pubmed #17244204 No free full text.
Abstract: During the past 20 years, several multicentre clinical trials have investigated different therapies for neovascular age-related macular degeneration (AMD). These landmark studies have provided the scientific community with powerful data regarding the ability of laser photocoagulation, verteporfin therapy, pegaptanib sodium and submacular surgery to treat particular choroidal neovascular lesion types. Accurate interpretation of data from these trials is essential to enable clinicians to make informed decisions about therapeutic interventions. Furthermore, several new treatment options are likely to become available in the next few years and clinicians will have to decide how effective these therapies may be, and how (or if) they should be used in clinical practice. It is therefore timely to review the strengths and weaknesses of the body of evidence for the currently available therapeutic options for patients with choroidal neovascularization due to AMD. Evaluation of the quality of reporting in past clinical trials will also enable critical review of new studies that will be published in the future. This review summarizes the design, reporting and results of key randomized clinical trials, in addition to evaluating the available evidence for new therapies and identifying the important issues that need to be considered when evaluating their efficacy.
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Review Cataract surgery and diabetic retinopathy. 2003
Menchini U, Cappelli S, Virgili G. · Eye Clinic II, Department of Oto-Neuro-Ophthalmological Surgical Sciences, University of Florence, Italy. · Semin Ophthalmol. · Pubmed #15513469 No free full text.
Abstract: Diabetes is a risk factor for the development of cataracts. Studies have shown an increased risk of ocular complications in diabetics after cataract surgery, but modern surgical techniques have minimized them, leading to an overall good visual outcome. Macular edema before surgery is the most common condition that limits post-operative visual recovery. Thus, pre-operative laser treatment is needed. Photocoagulation of preproliferative or early proliferative diabetic retinopathy is also advisable, due to the increased risk of iris neovascularization or retinopathy progression after surgery.
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Review When and how to do a grid laser for diabetic macular edema. 1999
Bandello F, Lanzetta P, Menchini U. · Department of Ophthalmology, University of Udine, Italy. · Doc Ophthalmol. · Pubmed #10896358 No free full text.
Abstract: Macular edema is a common feature of posterior segment diseases. It is an expression of abnormal permeability in either retinal vessels (inner blood-retinal barrier) or in the retinal pigment epithelium (outer blood-retinal barrier). It occurs in either a diffuse pattern where the macula appears generally thickened or, in more severe cases, as cystoid edema with the typical petaloid appearance. Grid laser treatment may be useful to reduce macular edema. Spots of 100-250 micrometers in diameter are applied to the whole posterior pole, one to two groups apart. The foveal avascular zone remains untouched. In patients treated bilaterally, areas temporal and nasal to the macula must be spared to prevent the development of deep scotomas. The mechanism yielding positive results with the grid technique is still debated. Among the most reliable hypotheses are: Proliferation of pigment epithelial cells, followed by and improved efficiency of the outer blood-retinal barrier; proliferation of endothelial cells in retinal capillaries followed by an improved efficiency of the inner blood-retinal barrier; improvement of the retinochoroidal exchanges, and finally, release by coagulative necrosis of a factor able to improve the efficiency of the blood-retinal barriers. Lasers with long wavelengths, such as krypton red and diode, are the most appropriate ones to perform grid treatment.
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Clinical Conference Intravitreal bevacizumab therapy for choroidal neovascularization secondary to age-related macular degeneration: 6-month results of an open-label uncontrolled clinical study. 2007
Giansanti F, Virgili G, Bini A, Rapizzi E, Giacomelli G, Donati MC, Verdina T, Menchini U. · Department of Oto-Neuro-Ophthalmological Surgical Sciences, Eye Clinic, University of Florence, Viale Morgagni 85, 50134 Florence, Italy. · Eur J Ophthalmol. · Pubmed #17415697 No free full text.
Abstract: PURPOSE: To investigate the 6-month safety and clinical outcomes of intravitreal injections of bevacizumab administered to treat choroidal neovascularization secondary to age-related macular degeneration. METHODS: Twenty-seven patients underwent 1.25 mg intravitreal injections of bevacizumab at baseline. A similar intravitreal injection was administered to all eyes at 1 and 2 month follow-up visits. At baseline and at each follow-up visit (1, 2, 3, and 6 months), patients underwent best-corrected visual acuity (BCVA) measurement, fluorescein angiography, indocyanine green angiography, and optical coherence tomography. Laboratory testing, visual field analyses, and endothelial cell counts were performed at baseline and third and sixth months. RESULTS: At 3 months, the mean BCVA remained substantially stable at 20/100. Mean central retinal thickness (CRT) decreased from 373 to 279 microm (p<0.01). Mean lesion greatest linear dimension (GLD) decreased from 4087 to 3782 microns (p<0.01). At 6 months, mean BCVA slightly decreased from 20/100(-1) to 20/125(-3) (not significant, p=0.40). Mean CRT was still inferior to baseline (305 microm, p<0.01). Mean lesion GLD was 4186 microm, not different from baseline values (p=0.59), but superior to 3-month mean GLD (p<0.01). Significant visual field defects or endothelial cell losses were not detected at 3 and 6 months. Laboratory testing did not reveal any clinically significant deviations compared to baseline values. CONCLUSIONS: Intravitreal therapy using bevacizumab over 6 months showed stabilization of visual acuity and choroidal neovascularization activity; the safety data were convincing.
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Clinical Conference Verteporfin therapy of subfoveal minimally classic choroidal neovascularization in age-related macular degeneration: 2-year results of a randomized clinical trial. 2005
Azab M, Boyer DS, Bressler NM, Bressler SB, Cihelkova I, Hao Y, Immonen I, Lim JI, Menchini U, Naor J, Potter MJ, Reaves A, Rosenfeld PJ, Slakter JS, Soucek P, Strong HA, Wenkstern A, Su XY, Yang YC, Anonymous00313. · No affiliation provided · Arch Ophthalmol. · Pubmed #15824216 No free full text.
Abstract: OBJECTIVE: To compare the treatment effect and safety of photodynamic therapy with verteporfin using a standard (SF) or reduced (RF) light fluence rate with that of placebo therapy in patients with subfoveal minimally classic choroidal neovascularization (CNV) with age-related macular degeneration. DESIGN: Phase 2, multicenter, double-masked, placebo-controlled, randomized clinical trial. SETTING: Nineteen ophthalmology practices in North America and Europe. PARTICIPANTS: Patients with initial best-corrected visual acuity of at least 20/250 and a lesion size of no greater than 6 Macular Photocoagulation Study (MPS) disc areas. METHODS: We randomly assigned 117 patients (1:1:1) to verteporfin infusion (6 mg/m(2)) and light application with an RF rate (300 mW/cm(2)) for 83 seconds (light dose of 25 J/cm(2)) or an SF rate (600 mW/cm(2)) for 83 seconds (light dose of 50 J/cm(2)) or to placebo infusion with RF or SF. Treatment was repeated every 3 months if the treating physician noted fluorescein leakage from CNV on angiography. Patients in whom a predominantly classic lesion developed could receive open-label standard verteporfin treatment. Best-corrected visual acuity was measured every 3 months, and angiographic changes were assessed by the Photograph Reading Center through the 3-month examination unless an ocular adverse event or conversion to a predominantly classic lesion was identified by an investigator. Safety was assessed throughout the study. All outcomes were on an intent-to-treat basis. RESULTS: One hundred three (88%) of 117 patients completed the 24-month examination. Twelve (30%) of 40 patients assigned to placebo received open-label standard verteporfin treatment after confirmation of presence of predominantly classic CNV. At month 12, a loss of at least 3 lines of visual acuity occurred in 5 (14%) of 36 eyes assigned to RF and 10 (28%) of 36 eyes assigned to SF, compared with 18 (47%) of 38 eyes assigned to placebo (RF, P = .002; SF, P = .08; RF + SF, P = .004). At month 24, this loss occurred in 9 (26%) of 34 eyes assigned to RF and 17 (53%) of 32 assigned to SF, compared with 23 (62%) of 37 eyes assigned to placebo (RF, P = .003; SF, P = .45; RF + SF, P = .03). Progression to predominantly classic CNV by 24 months was more common in the placebo group (11 [28%] of 39 patients compared with 2 [5%] of 38 in the RF group [P = .007] and 1 [3%] of 37 in the SF group [P = .002]). No unexpected ocular or systemic adverse events were identified. Treatment-related, usually transient visual disturbances were 13% with SF, 10% with placebo, and 5% with RF. CONCLUSIONS: Verteporfin therapy safely reduced the risks of losing at least 15 letters (> or =3 lines) of visual acuity and progression to predominantly classic CNV for at least 2 years in individuals with subfoveal minimally classic lesions due to age-related macular degeneration measuring 6 MPS disc areas or less. Based on the overall evidence available on verteporfin therapy for these lesions, the VIM Study Group would consider recommending verteporfin therapy for relatively small minimally classic lesions similar to those enrolled in the VIM Trial.
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Clinical Conference Light panretinal photocoagulation (LPRP) versus classic panretinal photocoagulation (CPRP) in proliferative diabetic retinopathy. 2001
Bandello F, Brancato R, Menchini U, Virgili G, Lanzetta P, Ferrari E, Incorvaia C. · Department of Ophthalmology, University of Udine, Udine, Italy. · Semin Ophthalmol. · Pubmed #15487693 No free full text.
Abstract: PURPOSE: We misled to verify whether a panretinal photocoagulation (PRP) performed using low levels of ARGON laser energy (light PRP) has the same efficacy as a PRP performed in a conventional fashion using argon green wavelengths (classic PRP) in eyes with high-risk proliferative diabetic retinopathy (HRPDR). Furthermore, we misled to compare the session number performed and the side effects produced by the two techniques. METHODS: Sixty-five eyes with HRPDR of 50 consecutive patients were enrolled in a prospective randomized controlled trial. In eyes selected for light PRP, a very light biomicroscopic effect on the retina was obtained for each spot. In eyes assigned to classic PRP, each spot produced a white-yellow biomicroscopic effect. Mean follow-up was 22.4 months +/- 9.7 in the light PRP and 21.6 months +/- 9.3 in the classic PRP group (p = 0.727). RESULTS: The initial mean logMAR visual acuity (VA) in the light PRP group was 0.12 +/- 0.13 and in the classic PRP group 0.14 +/- 0.15 (p = 0.493). The final mean VA in the former was 0.18 +/- 0.25, and in the latter 0.27 +/- 0.30 (p = 0.231). Median power was 235mW (100-540mW) for light and 420mW (200-950mW) for classic PRP (p < 0.001). Regression of HRPDR at the end of the follow-up was obtained in 30/31 eyes (97%) treated with classic PRP and in 31/34 eyes (91%) treated with light PRP (p = 0.615). The total mean session number was 7.4 +/- 2.4 for light and 9.9 +/- 2.2 for the classic PRP group (p < 0.001). Complications were more frequent in the classic PRP group. CONCLUSIONS: The efficacy of Light PRP is similar to that of classic Light PRP in eyes with HRPDR. Light PRP is associated with fewer complications and allows the reduction of the number of treatment sessions.
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Article Intravitreal bevacizumab (Avastin) for choroidal neovascularization in angioid streaks: a case series. 2009
Donati MC, Virgili G, Bini A, Giansanti F, Rapizzi E, Giacomelli G, Menchini U. · Department of Oto-Neuro-Ophthalmological Surgical Sciences, University of Florence, Florence, Italy. · Ophthalmologica. · Pubmed #18849633 No free full text.
Abstract: BACKGROUND: Intravitreal (IV) bevacizumab (Avastin(R), Roche), initially used for the off-label treatment of neovascular age-related macular degeneration (AMD), has extended itself to treat various ocular pathologies such as choroidal neovascularization not associated to AMD. METHODS: IV bevacizumab 1,25 mg (Avastin) was used in the treatment of choroidal neovascularization (CNV) in 6 eyes of 5 patients with angioid streaks. All cases had a history of photodynamic treatment (PDT) or laser treatment and all showed progressive worsening despite the use of these therapies. RESULTS: After injection patients were followed up at nearly 2-month intervals. IV Avastin was repeated in case of recurrence. Three eyes were treated combining PDT and IV Avastin. Cases were followed up for 7-14 months. All patients needed more IV injections. Five out of 6 eyes showed an improvement of BCVA and a slight reduction of leakage and size with FA. CONCLUSION: This small series suggests that IV Avastin might be useful in the treatment of CNV due to AS.
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Article Phenotypic intrafamilial variability associated with S212G mutation in the RDS/peripherin gene. 2007
Passerini I, Sodi A, Giambene B, Menchini U, Torricelli F. · Department of Genetic Diagnosis, Careggi University Hospital, Firenze, Italy. · Eur J Ophthalmol. · Pubmed #18050133 No free full text.
Abstract: PURPOSE: To describe an Italian family in which two separate phenotypes (retinitis pigmentosa and adult onset vitelliform macular dystrophy) are associated with an identical mutation (S212G) in the peripherin/RDS gene. This mutation has already been reported in patients with retinitis pigmentosa, but it has never been previously detected in association with adult onset vitelliform macular dystrophy. METHODS: A 38-year-old woman complained of bilateral mild metamorphopsias and on ophthalmologic examination she showed the clinical phenotype of adult onset vitelliform macular dystrophy. Her 62-year-old mother was clinically diagnosed with a retinitis pigmentosa, with a severe clinical course. RESULTS: In both patients, molecular genetic analysis revealed a 874A-->G transition in the exon 2 of the RDS gene leading to the amino acid change of S212G. CONCLUSIONS: Peripherin/RDS S212G mutation may have damaging effects on the formation and stability of the photoreceptors' disk structure and may be associated with different clinical phenotypes, even in the same family. Intrafamilial phenotypic variability has been reported for other RDS mutations; this supports the possible influence of modifier genes or environmental factors in the clinical expression of RDS gene variants. Moreover, it suggests that in patients with retinal degeneration and peripherin/RDS mutation, caution should be taken both in using molecular genetic results to predict the clinical course of the disease and in offering genetic counseling.
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Article A novel mutation in the VMD2 gene in an Italian family with Best maculopathy. free! 2007
Sodi A, Passerini I, Simonelli F, Testa F, Menchini U, Torricelli F. · Department of Oto-Neuro-Ophthalmological Surgical Sciences, University of Florence, Italy. · J Fr Ophtalmol. · Pubmed #17646752 links to free full text
Abstract: Vitelliform macular dystrophy (Best disease) is an inherited macular degeneration in which the primary defect is thought to occur at the level of the retinal pigment epithelium. The VMD2 gene, considered responsible for the disease, mapped to the long arm of chromosome 11, and it codifies the bestrophin protein, probably acting as a transmembrane ionic channel. In the present study, we screened for mutations the VMD2 gene in Italian patients with Best maculopathy. Five families with Best disease were recruited from central and southern Italy, and family members were evaluated by complete ophthalmologic examination and DNA analysis by means of DHPLC technology. Some mutations of the VMD2 gene were identified and among them there was a novel mutation (R218G), probably involving a functionally active region of the bestrophin protein. In spite of the small number of families considered, it was possible to note a significant phenotypic heterogeneity. First, in one family the R218C mutation was associated with early onset of choroidal neovascularization (CNV) in the affected mother and her son, while no CNV was reported in another family sharing the same mutation. Then a patient with the R25W mutation showed a multifocal location of the vitelliform deposits, while another family with the same mutation showed a typical isolated vitelliform disc in the macular area.
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Article Occurrence of full-thickness macular hole complicating Stargardt disease with ABCR mutation. 2006
Sodi A, Bini A, Passerini I, Menchini U, Torricelli F. · Department of Oto-Neuro-Ophthalmological Surgical Sciences, Eye Clinic, Firenze, Italy. · Eur J Ophthalmol. · Pubmed #16703556 No free full text.
Abstract: PURPOSE: To report an unusual episode of full-thickness macular hole complicating Stargardt disease with an ABCR mutation. METHODS: Case report . RESULTS: Fundus examination of a 20-year-old healthy man showed typical fundus manifestation with yellowish-round or fish-like flecks associated with vitreous macular adhesion and a round punched-out area in the right eye. Optical coherence tomography (OCT) illustrated a full-thickness macular hole. Molecular genetic examination of the ABCR gene showed two heterozygous missense mutations: R1108C (CGC-->TGC) in exon 22 and a splicing mutation IVS6--> 1GT - described in the literature in association with Stargardt disease. CONCLUSIONS: Macular hole was once described in other inherited retinal degenerations (Best disease and Bietti crystal line retinopathy). The pathogenesis gives rise to a host of speculations: widespread alteration of the retinal pigment epithelium; inflammatory mechanisms; a minor trauma which might cause subretinal fibrosis. Surgical procedures were not performed on our patient after his ophthalmologic history and findings were considered.
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Article Retinal angiomatous proliferation: association with clinical and angiographic features. 2006
Donati MC, Carifi G, Virgili G, Menchini U. · Eye Clinic, Department of Oto-Neuro-Ophthalmological Surgical Sciences, University of Florence, Florence, Italy. · Ophthalmologica. · Pubmed #16374046 No free full text.
Abstract: AIM: It was the aim of this study to evaluate the frequency of retinal angiomatous proliferation (RAP) and its association with specific clinical and angiographic characteristics in age-related macular degeneration (AMD). METHODS: A consecutive series of 126 newly diagnosed patients with exudative AMD was reviewed retrospectively. All underwent a complete ophthalmic examination, a red-free photograph and fluorescein angiography. Most patients (85/126) underwent indocyanine green choroidal angiography (ICGA). RAP was diagnosed when a connection between the retinal vasculature and the neovascular complex was recognized angiographically. RESULTS: Out of 126 patients with recent neovascular AMD, 17 had RAP (13.5%; 95% CI 8.1-20.7). The study eye of patients with RAP had more frequent hemorrhages (88.2 vs. 59.6%; p = 0.027), hard exudates (82.4 vs. 26.6%; p < 0.001), pigment epithelium detachment (64.7 vs. 23.8%; p = 0.001) and a hot spot in ICGA (70.6 vs. 22.1%; p < 0.001) with respect to the other forms of exudative AMD. Hemorrhages were more frequently superficial, multiple and within the edge of the lesion in the RAP group. Bilateral AMD was more common in the RAP group (70.6 vs. 38.0%; p = 0.011). No statistically significant differences were found regarding sex, age and visual acuity. CONCLUSION: RAP represents a common lesion in patients with neovascular AMD referred to a tertiary care clinic. The recognition of hemorrhages, hard exudates, pigment epithelium detachment or a hot spot in ICGA can assist a correct diagnosis.
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Article Fluorescein angiography and indocyanine green angiography for identifying occult choroidal neovascularization in age-related macular degeneration. 2005
Pece A, Sannace C, Menchini U, Virgili G, Galli L, Isola V, Brancato R. · Department of Ophthalmology, Hospital of Melegnano, Predabissi (MI), Italy. · Eur J Ophthalmol. · Pubmed #16329062 No free full text.
Abstract: PURPOSE: To assess whether fluorescein angiography (FA) alone without indocyanine green angiography (ICGA) can identify and localize occult choroidal neovascularization (CNV) in age-related macular degeneration (ARMD). METHODS: Seventy-nine eyes of 77 consecutive patients with occult CNV were evaluated independently by two skilled physicians at first with FA alone and then with FA combined with ICGA by fundus camera. RESULTS: The agreement between FA and ICGA was 73% and 68% for the two physicians (K=0.585 and 0.512, respectively). The first operator correctly identified 20/27 as plaque CNV; six had different sizes and locations. The second operator identified 25/30, with one mistaken for size and location. For focal CNV the first operator identified 34/39, and the second one 23/35. CONCLUSIONS: Comparing the FA results with ICGA, CNV was correctly identified in about 60% of cases. Therefore, ICGA should be considered an indispensable diagnostic test to identify the presence, the type, and the location of occult CNV.
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Article Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: meta-analysis of 2-year safety results in three randomized clinical trials: Treatment Of Age-Related Macular Degeneration With Photodynamic Therapy and Verteporfin In Photodynamic Therapy Study Report no. 4. 2004
Azab M, Benchaboune M, Blinder KJ, Bressler NM, Bressler SB, Gragoudas ES, Fish GE, Hao Y, Haynes L, Lim JI, Menchini U, Miller JW, Mones J, Potter MJ, Reaves A, Rosenfeld PJ, Strong A, Su XY, Slakter JS, Schmidt-Erfurth U, Sorenson JA, Anonymous00093, Anonymous00094. · No affiliation provided · Retina. · Pubmed #15076937 No free full text.
Abstract: PURPOSE: We sought to evaluate the detailed safety profile of photodynamic therapy with verteporfin in patients with subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (ARMD) from the combined analysis of three multicenter, double-masked, placebo-controlled, randomized 24-month clinical trials of similar design (TAP Investigation Studies A and B and the VIP ARMD Trial), and to clarify the adverse reaction information in the current verteporfin product prescription information approved in the United States. METHODS: Nine hundred forty-eight patients were randomly assigned to verteporfin or placebo. Treatment was administered as described in previous reports. All general entry criteria were similar, so systemic safety results were combined for this analysis. Entry criteria for CNV lesion composition and visual acuity in the two TAP Investigation trials was different from those used in the VIP ARMD trial, so ocular safety results for the treated eye were not combined. RESULTS: The percentage of patients who experienced at least one ocular or nonocular adverse event, regardless of relationship to therapy, was similar between the verteporfin and placebo groups (92.3 and 89.1%, respectively, P = 0.114). The overall incidence of study eye adverse events was not significantly different between verteporfin and placebo. The only clinically relevant ocular adverse events reported with higher incidence after verteporfin compared with placebo were visual disturbances (22.1 versus 15.5% in TAP [P = 0.054] and 41.7 and 22.8% in VIP [P < 0.001]). Acute severe visual acuity decrease (defined as a visual acuity letter score decrease of at least 20, equivalent to at least four-line decrease, within 7 days of therapy) occurred in 3 patients treated with verteporfin in the TAP Investigation (0.7%) and 11 in the VIP ARMD trial (4.9%). Systemic adverse events with increased incidence after verteporfin compared with placebo, most of which were transient and mild or moderate, were injection site reactions (13.1 versus 5.6%; P < 0.001), photosensitivity reactions (2.4 versus 0.3%; P = 0.016), and infusion-related back pain (2.4 versus 0%; P = 0.004). No clinically relevant difference was observed between the verteporfin and placebo groups in any other adverse event. CONCLUSION: In 948 ARMD patients, verteporfin therapy had an overall safety profile similar to that for placebo, with a few exceptions. Visual disturbances, including acute severe visual acuity decrease, did not affect the net vision outcome benefits associated with treatment that has been reported previously. This detailed safety profile of verteporfin therapy clarifies the adverse reaction information in the current verteporfin product prescription information.
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Article Effect of lesion size, visual acuity, and lesion composition on visual acuity change with and without verteporfin therapy for choroidal neovascularization secondary to age-related macular degeneration: TAP and VIP report no. 1. 2003
Blinder KJ, Bradley S, Bressler NM, Bressler SB, Donati G, Hao Y, Ma C, Menchini U, Miller J, Potter MJ, Pournaras C, Reaves A, Rosenfeld PJ, Strong HA, Stur M, Su XY, Virgili G, Anonymous00153, Anonymous00154. · · Am J Ophthalmol. · Pubmed #12967792 No free full text.
Abstract: PURPOSE: To determine whether differences in baseline lesion size and visual acuity might explain differing results found in three different lesion compositions (predominantly classic, minimally classic, and occult with no classic) among three placebo-controlled, randomized clinical trials evaluating photodynamic therapy with verteporfin (Visudyne, Novartis AG), also termed verteporfin therapy, in patients with subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD). METHODS: Exploratory analyses were conducted in patients with predominantly classic or minimally classic lesions at enrollment in the Treatment of AMD with Photodynamic Therapy (TAP) Investigation and in AMD patients with occult with no classic CNV in the Verteporfin In Photodynamic Therapy (VIP) Trial. Baseline characteristics of patients among these three lesion compositions were compared. In addition, multiple linear regression modeling was used to explore the effect of baseline lesion size, visual acuity, and lesion composition on mean change in visual acuity from baseline to 24 months. RESULTS: At baseline, the mean size of predominantly classic lesions (3.4 disk areas) was smaller than that of minimally classic (4.7 disk areas) and occult with no classic lesions (4.3 disk areas). In the multiple linear regression model of individual lesion compositions, there was a significant treatment-by-lesion-size interaction for minimally classic and occult with no classic lesions, but not for predominantly classic lesions. Interaction between treatment and baseline visual acuity was not significant for any lesion composition. Small verteporfin-treated lesions lost less vision than large verteporfin-treated lesions in each lesion composition. In the multiple linear regression model that included all lesion compositions, lesion size was a more significant predictive factor for the magnitude of treatment benefit than either lesion composition or visual acuity. Smaller (4.0 disk areas or less) minimally classic and occult with no classic lesions had similar visual acuity outcomes to those observed in predominantly classic lesions. CONCLUSIONS: Based on exploratory analyses, lesion size in the TAP Investigation and VIP Trial was an important predictor of the magnitude of treatment benefit with verteporfin therapy in occult with no classic and minimally classic lesion compositions. In patients with AMD, treating smaller rather than larger neovascular lesions, regardless of lesion composition, likely will result in a better level of visual acuity.
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Article Photodynamic therapy in adult-onset vitelliform macular dystrophy misdiagnosed as choroidal neovascularization. 2002
Menchini U, Giacomelli G, Cappelli S, Giansanti F, Romani A, Virgili G. · Department of Oto-Neuro-Ophthalmological Surgical Sciences, Eye Clinic II, University of Florence, Viale Morgagni 85, 50134 Florence, Italy. · Arch Ophthalmol. · Pubmed #12470159 No free full text.
This publication has no abstract.
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Article Unilateral macular retinoschisis with stellate foveal appearance in two females with myopia. 2000
Menchini U, Brancato R, Virgili G, Pierro L. · Department of Ophthalmology, University of Udine, Italy. · Ophthalmic Surg Lasers. · Pubmed #10847501 No free full text.
Abstract: Stellate foveal retinoschisis is considered the hallmark of X-linked retinoschisis. We describe the finding of unilateral retinoschisis with stellate foveal appearance in 2 females with myopia who had no evidence of familial disease. Optical coherence tomography (OCT) and fluorescein angiography were obtained in both cases. Neither patient had a family history of low vision, night blindness, or retinal detachment. Visual acuity in the affected eyes was 20/50 and 20/25, respectively. Both fellow eyes had normal fundi, except for mild myopic changes. With OCT, widespread retinal splitting was detected at the posterior pole in the affected eyes, whereas the fellow eyes were normal. In one case, OCT showed that foveal retinoschisis represented the macular involvement of a flat inferior retinoschisis, although this was not clinically apparent. Macular retinoschisis with stellate foveal appearance may rarely be associated with pathologic myopia. OCT was useful to establish the true extension of these macular changes.
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Minor Retinal astrocytic hamartoma and Stargardt's disease: unusual association in a patient with ABCR mutation without phacomatosis. 2007
Bini A, Sodi A, Passerini I, Menchini U, Torricelli F. · No affiliation provided · Clin Experiment Ophthalmol. · Pubmed #17997789 No free full text.
Abstract: We report the unusual association of a retinal astrocytic hamartoma and Stargardt's disease in a patient with ABCR mutation. A healthy 24-year-old man exhibited the typical fundus appearance of Stargardt's disease in both eyes, associated with a white, well-circumscribed, elevated lesion in the inferotemporal area of the right eye. Molecular genetic examination of the ABCR gene detected three heterozygous missense mutations, described in the literature in association with Stargardt's disease. Optical coherence tomography, fluorangiography, electroretinography and B scan ultrasonography were performed. The clinical findings were consistent with the diagnosis of retinal astrocytic hamartoma. The connection between Stargardt's disease and this tumour has never been previously reported. The astrocytic hamartoma of our patient showed unusual clinical features. This association is probably incidental.
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