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Phase 3 studies of lampalizumab for geographic atrophy enrolling
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MIAMI — Phase 3 studies of lampalizumab are underway based on results of the phase 2 MAHALO study, which showed evidence that treatment slows the rate of geographic atrophy progression in patients with age-related macular degeneration, a speaker told colleagues.
Carl D. Regillo
“Certainly there is a significant unmet medical need with regard to geographic atrophy,” Carl D. Regillo, MD, said at Angiogenesis, Exudation, and Degeneration 2015. “There’s more than 5 million people worldwide affected by GA, and there’s no effective treatment.”
Lampalizumab (Roche) is an antibody fragment that binds to factor D and inhibits the activation of the alternative pathway cascade, a suggested mechanism for progression of geographic atrophy.
To further study the use of lampalizumab for treating geographic atrophy, identical prospective phase 3 studies — Chroma and Spectri — are each enrolling 936 patients randomized 2:1:2:1 to receive 10 mg lampalizumab every 4 weeks, sham injections every 4 weeks, 10 mg lampalizumab every 6 weeks or sham injections every 6 weeks. Presence or absence of complement factor I is considered in the enrollment. Primary endpoint at 1 year is change in geographic atrophy area from baseline assessed by fundus autofluorescence.
Secondary efficacy endpoints will evaluate visual function outcomes potentially more relevant for quality of life, according to the presentation, including reading speed, patient-reported outcomes on the National Eye Institute’s VFQ-25, microperimetry, low-light visual acuity and best corrected visual acuity.
“There’s a lot we know already about GA progression from large studies, such as AREDS, but what we don’t know is in regard to visual function with time to progression of geographic atrophy in our patients with AMD,” Regillo said.
Proxima A and Proxima B, two longitudinal non-interventional studies, will gather additional scientific data on visual function in patients with geographic atrophy, as well as information on relationships between genetics and geographic atrophy progression.
Disclosure: Regillo reports receiving research support from Acucela, Allergan, Genentech, GlaxoSmithKline, Ocala, Regeneron and ThromboGenics and consulting for Acucela, Allergan, Genentech, Regeneron and ThromboGenics.