A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test SS-31 (Elamipretide).

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: inability to self-administer eye drops; ocular conditions:; ocular hypertension or glaucoma, dry eye, and any other ocular pathology in the study eye requiring treatment with topical ophthalmic drops.

How the Study Was Run

Design: non-randomized and open-label.

Everyone knew when SS-31 (Elamipretide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-11 with completion listed for 2015-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence and severity of systemic and ocular adverse events (time frame: From Baseline to Day 28). Change from Baseline in vital sign measurements (time frame: From Baseline to Day 28). Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale (time frame: From Baseline to Day 28).

It also tracked 4 secondary outcomes, for example Change in central subfield thickness, Change from Baseline in widefield angiography, Change from Baseline in fundus autofluorescence pattern including the occurrence of and aggregate size of areas of macular atrophy and Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of SS-31 (Elamipretide) in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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