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Phase 1 study of anti-VEGF agent shows good tolerance, improvement in BCVA
Ophthalmology. 2009;116(11):2141-2148.
Neovascular age-related macular degeneration patients who received high doses of an intraocular injection of an anti-VEGF agent had an improvement in best corrected visual acuity of a mean 13.5 letters, a study found.
"Intravitreal injection of up to 4 mg of VEGF Trap-Eye in patients with [neovascular AMD] was well-tolerated with no evidence of ocular inflammation. ... Several patients, especially those receiving 2 or 4 mg of VEGF Trap-Eye, showed substantial improvement in BCVA associated with reductions in foveal thickness," the study authors said.
The phase 1 dose-escalation, multicenter, interventional clinical trial looked at 21 patients who had neovascular AMD, lesions of 12 disc areas in size or less, and 50% or more of active choroidal neovascularization.
Patients received a single intraocular injection of VEGF Trap-Eye (Regeneron and Bayer HealthCare) in one of the following amounts: 0.05 mg, 0.15 mg, 0.5 mg, 1 mg, 2 mg or 4 mg.
Follow-up was up to 12 weeks.
The researchers found no serious adverse events or intraocular inflammation following injections. At 6 weeks, the mean increase in visual acuity for all treatment doses was 4.43 letters; mean decrease in excess foveal thickness was 104.5 µm.