At a glance
ClinicalIndex Comparison Record- ✓Age ≥55 years with at least 1 eye with AMD with non-central geographic atrophy (GA) confirmed by FAF
- ✓Study eye GA size ≥0.05 mm² and ≤10.16 mm² total, completely within FAF 30 or 35° image, ≥150 μm from foveal center with preserved outer retinal structural details
- ✓No CNV history or evidence by OCT or FA in study eye
- ✓BCVA ≥55 letters ETDRS (Snellen ≥20/70) and low-luminance BCVA ≥10 letters in study eye at Screening and Baseline
- ✕Exudative AMD or CNV in study eye
- ✕Retinal vein occlusion, diabetic retinopathy, vitreous hemorrhage, retinal detachment, or macular hole (stages 2-4) in study eye
- ✕Epiretinal membrane causing retinal contour distortion or vitreomacular traction in study eye
- ✕Advanced glaucoma (cup-to-disc >0.8) or uncontrolled glaucoma (IOP >22 mmHg on treatment) or using >2 anti-glaucoma medications in study eye
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Randomized, Double-Masked, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Elamipretide in Subjects With Age-Related Macular Degeneration With Non-central Geographic Atrophy
In Brief
A Phase 2 clinical trial evaluating Subcutaneous elamipretide through the elamipretide delivery system and Subcutaneos placebo through the elamipretide delivery system for Age-related Macular Degeneration. Completed, enrolled 176 participants across 37 sites.
Detailed Summary
A randomized, double-masked, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of elamipretide in subjects with Age-Related Macular Degeneration with non-central Geographic Atrophy.
Study Details
Timeline
Interventions
Subjects will be randomized in a 2:1 ratio to receive either elamipretide or placebo through the elamipretide delivery system. Subjects will dose daily for up to 48 weeks.
Subjects will be randomized in a 2:1 ratio to receive either elamipretide or placebo through the elamipretide delivery system. Subjects will dose daily for up to 48 weeks.