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Anti-PDGF, anti-VEGF combination for neovascular AMD well tolerated
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MIAMI — An anti-PDGF agent combined with an anti-VEGF was well-tolerated by patients with neovascular age-related macular degeneration, according to results of a phase 1 clinical trial.
Jeffrey S. Heier
“The phase 1 study did not reveal any treatment-emergent adverse events and no reports of inflammation,” Jeffrey S. Heier, MD, said at Angiogenesis, Exudation, and Degeneration 2015. “The treatments were well-tolerated.”
Ongoing study focuses on REGN2176-3 (Regeneron), an anti-PDGF receptor-beta monoclonal antibody co-formulated with 2 mg Eylea (aflibercept, Regeneron) as a single 50-µL intravitreal injection.
PDGF, a growth factor involved in the regulation of cell growth and division, plays a major role in blood vessel formation and maturation, Heier said.
The phase 1 open-label study included four cohorts of three patients who received REGN2176-3 combined with aflibercept at baseline and at 4 weeks.
Mean baseline best corrected visual acuity was 63 letters, and mean baseline central retinal thickness was 312 µm (range: 198 µm to 454 µm).
Combined anti-PDGF/anti-VEGF dosage ratios were 0.2 mg:2 mg in the first cohort, 0.5 mg:2 mg in the second cohort, 1 mg:2 mg in the third cohort and 3 mg:2 mg in the fourth cohort.
Study results showed no dose-limiting toxicities, intraocular inflammation or treatment-related serious adverse events.
Visual acuity was stable or increased in a majority of patients.
Central retinal thickness decreased in all four cohorts, with the greatest decrease in the first and second cohorts, “but keep in mind cohorts one and two had the large majority of treatment-naïve patients,” Heier said.
A phase 2 clinical trial scheduled to begin in the first quarter will include 500 patients randomized to receive high-dose or low-dose REGN2176-3 combined with aflibercept. A control group will receive aflibercept 2 mg alone.
“We’re anxious to see the phase 2 study begin,” Heier said.
Disclosure: Heier reports he is on the scientific advisory board of and receives research funding from Regeneron.