Macular Degeneration: Anonymous00216

Anonymous00215, Anonymous00216, Anonymous00217. · Novartis Ophthalmics Inc., Duluth, GA 30097, USA. · Retina. · Pubmed #11884872 No free full text.

Abstract: OBJECTIVE: Guidelines were developed based on best available scientific data as well as consensus of expert opinion in absence of controlled clinical trial data to: 1) assist ophthalmologists with selection of patients for whom photodynamic therapy with verteporfin, termed "verteporfin therapy," should be considered; and 2) offer suggestions regarding treatment, follow-up, and re-treatment. METHODS: Consensus from roundtable of retina specialists who either participated in randomized clinical trials evaluating verteporfin therapy or had clinical experience with verteporfin therapy was based on results of these trials and expert opinion. Additional input and advice were received from representatives on behalf of the Macula Society, the Retina Society, and the Vitreous Society, as well as principal investigators of randomized clinical trials evaluating verteporfin therapy. RESULTS: Patient selection criteria included the following: 1) in cases due to age-related macular degeneration (AMD), lesion composition either predominantly classic choroidal neovascularization (CNV) or occult with no classic CNV; 2) CNV location subfoveal or so close to the foveal center that conventional laser photocoagulation treatment almost certainly would extend under the center; 3) lesion etiology from AMD, pathologic myopia, or other causes in which the outcome without treatment is likely to be worse than with treatment; 4) vision at a level where further loss would be recognized as detrimental to the quality of life of the patient. Criteria did not include lesion size, except in cases composed of occult with no classic CNV in AMD in which therapy for lesions >4 Macular Photocoagulation Study (MPS) disc areas usually should be considered only when presenting with lower levels of best-corrected visual acuity. Criteria also did not include patient age, history of systemic arterial hypertension, or prior laser photocoagulation. Therapy should occur ideally within 1 week of the initial fluorescein angiogram on which the clinical decision to treat is based. Patients should return for follow-up at least as often as every 3 months after any initial or subsequent treatment to determine if there is fluorescein leakage from CNV. Re-treatment should be considered as often as every 3 months if fluorescein leakage from CNV is noted at that time. Re-treatment could be deferred if the biomicroscopic and fluorescein angiographic appearance of the lesion is unchanged and shows minimal leakage, especially when there is no subretinal fluid or fluorescein leakage from CNV underlying the center of the foveal avascular zone. Patients should avoid exposure of skin or eyes to direct sunlight or bright indoor light for 48 hours after treatment or until resolution of any swelling or discoloration from extravasation. CONCLUSION: These recommendations provide guidelines on the role of verteporfin therapy in the management of CNV due to AMD and other causes. Revisions of these guidelines may be required as new data become available.

Anonymous00216, Aiello LP, Davis MD, Girach A, Kles KA, Milton RC, Sheetz MJ, Vignati L, Zhi XE. · Beetham Eye Institute, Joslin Diabetes Center, 1 Joslin Place, Boston, MA 02215, USA. · Ophthalmology. · Pubmed #16989901 No free full text.

Abstract: OBJECTIVE: To evaluate the effect of ruboxistaurin, an orally administered protein kinase C beta (PKC beta) isozyme-selective inhibitor, on vision loss in patients with diabetes. DESIGN: Thirty-six-month, randomized, double-masked, placebo-controlled, parallel, multicenter trial. PARTICIPANTS: Six hundred eighty-five patients randomized at 70 clinical sites. METHODS: Ophthalmologic examination was performed at screening and at each 3-month visit. Retinopathy status was assessed every 6 months with Early Treatment Diabetic Retinopathy Study (ETDRS) standard 7-field 30 degrees color stereoscopic fundus photography. Levels of diabetic retinopathy and diabetic macular edema were determined by 2 independent graders masked to site and treatment assignment, with additional independent adjudication as required. Eligible patients had a best-corrected visual acuity (VA) score of > or =45 letters, retinopathy level > or = 47A and < or = 53E, and no prior panretinal photocoagulation in at least one eye. MAIN OUTCOME MEASURE: Effect of oral ruboxistaurin (32 mg/day) on reduction of sustained moderate visual loss (> or =15-letter decrease in ETDRS VA score maintained > or = 6 months) in patients with moderately severe to very severe nonproliferative diabetic retinopathy. RESULTS: Sustained moderate visual loss occurred in 9.1% of placebo-treated patients versus 5.5% of ruboxistaurin-treated patients (40% risk reduction, P = 0.034). Mean VA was better in the ruboxistaurin-treated patients after 12 months. Baseline-to-end point visual improvement of > or =15 letters was more frequent (4.9% vs. 2.4%) and > or =15-letter worsening was less frequent (6.7% vs. 9.9%) in ruboxistaurin-treated patients relative to placebo (P = 0.005). When clinically significant macular edema was >100 microm from the center of the macula at baseline, ruboxistaurin treatment was associated with less frequent progression of edema to within 100 microm (68% vs. 50%, P = 0.003). Initial laser treatment for macular edema was 26% less frequent in eyes of ruboxistaurin-treated patients (P = 0.008). CONCLUSION: Oral ruboxistaurin treatment reduced vision loss, need for laser treatment, and macular edema progression, while increasing occurrence of visual improvement in patients with nonproliferative retinopathy.