Intravitreal avacincaptad pegol appears to significantly decrease the rate of geographic atrophy secondary to macular degeneration with minimal adverse events.
Study design
This was an international, multicenter, prospective, double-masked, randomized, sham-controlled phase 2/3 study to assess the safety and efficacy of avacincaptad pegol for geographic atrophy (GA). Progression of GA was assessed using the mean rate of change in GA over 12 months as measured by fundus autofluorescence (FAF). A total of 286 patients were randomized into groups based on avacincaptad pegol dose (1 mg, 2 mg, 4 mg, or sham).
Outcomes
There was a 27.4% decrease in the mean rate of GA change in the avacincaptad pegol 2 mg group (0.110 mm, P = 0.0072) compared to sham controls and a 27.8% decrease (0.124 mm, P = 0.0051) in the avacincaptad pegol 4 mg group compared to sham controls. Choroidal neovascular membrane was reported in the fellow eyes of 10 participants (3.5%), in the study eye of 3 sham-group participants (2.7%), in 1 avacincaptad pegol 1 mg group participant (4%), in 6 avacincaptad pegol 2 mg group participants (9.0%), and in 8 avacincaptad pegol 4 mg group participants (9.6%).
Limitations
Patients who developed choroidal neovascularization (CNV) during the trial were discontinued from the study. Further data about their outcomes would be helpful to better understand the impact of CNV development in this population.
Clinical significance
Avacincaptad pegol appears to be effective in slowing down GA progression. There is a higher rate of CNV development in patients undergoing 2 mg or 4 mg avacincaptad pegol treatment than those receiving 1 mg treatment or in the control group.
Financial Disclosures: Dr. Ajay Kuriyan discloses financial relationships with Adverum, Annexon, National Eye Institute (Grant Support); Alimera Sciences, Allergan, Bausch + Lomb, EyePoint Pharmaceuticals, Novartis, Alcon Pharmaceuticals (Consultant/Advisor); Genentech (Consultant/Advisor, Grant Support); Lumata Health (Consultant/Advisor, Private Equity/Stock Holder); Optos, Spark Therapeutics (Lecture Fees/Speakers Bureau); Recens Medical (Consultant/Advisor, Private Equity/Stock Holder).