Complement inhibitor and anti-VEGF may be safe for AMD treatment

FORT LAUDERDALE, Fla. — Intravitreal injection of an anti-VEGF agent and a complement inhibitor proved safe in treating age-related macular degeneration, a speaker said here.

Scott W. Cousins, MD, presented study results at the Association for Research in Vision and Ophthalmology meeting.

"Drusen contain all the different complement family of molecules, not just the effectors but also the activator and inhibitor," Dr. Cousins said. "Surprisingly, anti-VEGF is a complement pathway. So, clearly, complement plays a role in AMD. The issue, then, for pharmaceutical companies is, which indications?"

Dr. Cousins and colleagues set out to assess the safety of intravitreal injection of the aptamer ARC1905, a complement factor 5 inhibitor, combined with Lucentis (ranibizumab, Genentech).

The prospective, non-controlled multicenter study included 58 patients with all clinical subtypes of subfoveal neovascular AMD. Patients received three to six monthly injections of 0.03 mg, 0.3 mg, 1 mg or 2 mg of ARC1905 in conjunction with 0.5 mg of ranibizumab.

Outcome measures included visual acuity and central foveal thickness as measured by optical coherence tomography.

Study results showed that increased dosing was safe and tolerable for all patients. In addition, patients with less initial foveal thickness regained better vision, Dr. Cousins said.

Manufacturer Ophthotech plans to proceed with a phase 1 clinical trial of ARC1905 as monotherapy in treating non-neovascular AMD. The study will involve five intravitreal injections of ARC1905 over a period of 48 weeks: three monthly doses followed by two quarterly doses.

Inclusion criteria will be geographic atrophy associated with drusen and drusen in the fellow eye. Outcome measures will include visual acuity and anatomic changes.

Study enrollment is complete, Dr. Cousins said.

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