ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

What Was Tested

The trial (phase 3) is built around SS-31 (Elamipretide).

It had two arms (groups): Elamipretide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 313 actual participants took part.

It was open to people of any sex aged from 55 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Well-demarcated area(s) of GA. GA in the study eye at the Screening Visit may be multi-focal, but the cumulative GA lesion and size (by FAF, as determined by the Reading Center) must:. Be ≥ 0.50 mm2 and ≤ 10.16 mm2 AND. Reside completely within the FAF 30- or 35-degree image. BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) score of ≥ 55 letters in the study eye.

The full record lists 17 inclusion and 43 exclusion criteria; among the exclusions: the absence of observable hyper-faf at the margins of the ga in the study eye at the screening visit by the reading center; evidence of exudative amd or cnv in the study eye by history or fa , as determined by the reading center; presence of retinal vein occlusion in the study eye.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this SS-31 (Elamipretide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The SS-31 (Elamipretide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received SS-31 (Elamipretide).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-05-30 with completion listed for 2027-08.

It ran at 53 sites in United States (31), Italy (5), Spain (4), United Kingdom (4), Germany (3) and Hungary (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Week 48 Rate of change in the macular area of photoreceptor loss (time frame: Baseline, Week 48).

It also tracked 4 secondary outcomes, for example Week 72 Rate of change in the Macular area of photoreceptor loss, Week 96 Rate of change in the Macular area of photoreceptor loss, Proportion of subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best-Corrected Visual Acuity (LL BCVA) and Proportion of subjects gaining ≥ 15 letters in Low Luminance Best-Corrected Visual Acuity (LL BCVA).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of SS-31 (Elamipretide) in 313 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the SS-31 (Elamipretide) compound page, all human trials.