ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA

What Was Tested

The trial (phase 2) is built around SS-31 (Elamipretide).

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

Once daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.

The registry classes the interventions as combination product.

More on the Plan

The study drug (i.e., elamipretide or placebo) was administered once daily via SC injection using the elamipretide delivery system during the 48 week Treatment Period.

After completion of the 48-week Treatment Period subjects continued to be monitored for safety during the 4-week Follow-up Period and an end of study (EOS) Follow-up Visit was conducted at Week 52.

Who Took Part

176 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: Adults ≥ 55 years of age with at least 1 eye with AMD with non-central GA as determined by FAF. GA in the study eye at the Screening Visit may be multi-focal, but the cumulative GA lesion and size must:. Be ≥ 0.05 mm2 and ≤ 10.16 mm2 and. Reside completely within the FAF 30 or 35 degree image. Must be at least 150 μm from foveal center with preserved outer retinal structural details.

The full record lists 11 inclusion and 37 exclusion criteria; among the exclusions: the absence of observable hyper-faf at the margins of the ga in the study eye(only for lesions ≥ 0.25mm2); presence or diagnosis of exudative amd or cnv in the study eye; presence of retinal vein occlusion in the study eye.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on SS-31 (Elamipretide), so expectations could not easily colour the readings.

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

It started in 2019-03-27 with completion listed for 2022-02-22.

It ran at 37 sites in United States (37).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): LL BCVA Score Change From Baseline (time frame: Baseline and Weeks 4, 8, 12, 24, 36, 48). GA Area Change From Baseline by OCT (time frame: Baseline and Weeks 12, 24, 36, 48).

It also tracked 3 secondary outcomes, for example LL RA Change From Baseline, BCVA Change From Baseline and GA Area as Measured by Fundus Autofluorescence (FAF) Change From Baseline.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of SS-31 (Elamipretide) in 176 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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