Clinical Trials Resource Center

Macular Edema

November 4, 2013

Regeneron Pharmaceuticals issued results from a phase III study ofEYLEA (aflibercept) Injection for the treatment of macular edema following Branch Retinal Vein Occlusion (BRVO). The phase III trial was a doublemasked, randomized, active-controlled study of 183 patients who received either intravitreal EYLEA 2mg every four weeks or laser treatment, through week 24. In this trial, 53% of patients who received EYLEA 2mg every four weeks gained at least 15 letters in vision from baseline at week 24, the primary endpoint of the study, compared to 27% of patients who received laser, a standard-of-care treatment (p<0.001). Patients who received EYLEA 2mg every four weeks achieved a 17 letter mean improvement over baseline in best corrected visual acuity (BCVA) compared to a 6.9 letter mean improvement in patients who received laser (p<0.0001), a key secondary endpoint. Regeneron intends to submit a regulatory application for marketing approval for macular edema in the U.S. within the next several months.

July 21, 2008

Alimera reported positive interim results from a phase II trial of Medidur for the treatment of diabetic macular edema (DME). This 36-month, open-label study enrolled 36 subjects who received either a low dose (0.23 microgram per day) or a high dose (0.45 microgram per day) of Medidur. Pharmacokinetic data indicated that 20% of the low dose subjects and 18% of the high dose subjects showed an improvement in best-corrected visual acuity (BCVA) of 15 letters or greater from baseline. In addition, both the low dose and the high dose of Medidur resulted in a significant reduction in retinal thickness as compared to the baseline. Treatment was generally well tolerated; no adverse events related to intraocular, or inner eye, pressure were seen in the low dose group. In the high dose group, 12% of the high subjects experienced intraocular pressure increases of greater than 30 mmHg. Based on the results, the trial will continue as planned.

May 12, 2003

Oculex Pharmaceuticals reported positive results from a phase II trial investigating Posurdex, a dexamethasone releasing implant for macular edema. Results showed that after 90 days of receiving Posurdex, subjects experienced a statistically significant improvement in visual acuity compared with subjects receiving no treatment, as measured on a standard eye chart. Data showed that measures of edema demonstrated statistically significant decreases in both retinal thickness and fluorescein leakage. The randomized, multi-center, dose ranging study enrolled 306 subjects who received either a single Posurdex implant containing dexamethasone, or no treatment. The primary efficacy endpoint was to determine whether Posurdex could provide a two-line or greater improvement in visual acuity. Posurdex displayed a positive safety profile with only 4% of subjects experiencing a mild rise in intraocular pressure following treatment.

QLT and Novartis Ophthalmics reported positive results from a phase IV trial investigating Visudyne (verteporfin), a photodynamic therapy for the treatment of choroidal neovascularization. Results suggested that subjects with minimally classic lesions who were treated with Visudyne therapy had a reduced risk of vision loss compared with placebo-treated subjects. Data showed that the mean change in visual acuity scores for Visudyne treated subjects was higher in each group compared with subjects given placebo. The trial also demonstrated that fewer Visudyne-treated subjects developed predominantly classic choroidal neovascularization compared with placebo. The 12-month, multi-center study enrolled 117 subjects with choroidal neovascularization due to age-related macular degeneration. The data confirms six-month trial results presented earlier this year at the Macula Society annual meeting.

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