ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone Preservation

Ehlers JP, Hu A, Boyer D, et al. · Ophthalmology Science

Missed both primary endpoints (low-luminance visual acuity and geographic-atrophy area), with nominally significant secondary signals — 43-47% less ellipsoid-zone degradation and more patients gaining ≥10 letters (14.6% vs 2.1%). Adverse events in 86% on drug versus 71% on placebo, dominated by injection-site reactions.

Population

176 adults with dry AMD and noncentral geographic atrophy

Intervention

Elamipretide 40 mg subcutaneous daily for 48 weeks

Comparator

Placebo (2:1 randomization)

Limitations

Phase 2 designed at alpha 0.10; the positive findings are nominal secondary endpoints now awaiting the phase 3 (ReNEW); sponsor employees among authors.