Table of contents
- Trial overview
- Study design and phase
- Who can participate
- What is being measured
- Trial status and size
Trial overview
The available study is titled eDREAM and is a phase 2 trial of GAL-101 2% ophthalmic solution in patients with non-foveal geographic atrophy secondary to non-neovascular age-related macular degeneration.[1]
This trial is designed to test both efficacy and safety, meaning it wants to see whether the study treatment helps and whether it can be used safely in the study setting.[1]
Study design and phase
The study is described as double-masked, randomized, multicenter, parallel group, and placebo-controlled.[1]
Double-masked means that neither the participants nor the study team know who receives the study treatment or the placebo during the trial.[1]
Randomized means participants are assigned by chance, and placebo-controlled means one group receives a look-alike treatment without the active study drug.[1]
Multicenter means the trial takes place at more than one study site, and parallel group means the groups are followed at the same time.[1]
Who can participate
The target population is people with non-foveal geographic atrophy secondary to non-neovascular age-related macular degeneration.[1]
In simple terms, this means the study is for patients with a specific type of retina damage from age-related macular degeneration, and the center of sharp vision, called the fovea, is not yet involved.[1]
The trial data do not provide extra eligibility details such as age limits, lab tests, or other inclusion and exclusion rules.[1]
What is being measured
The main endpoint is the annual rate of change in the area of geographic atrophy, measured by fundus autofluorescence from baseline to the last on-treatment visit.[1]
Baseline means the starting point before treatment begins, and the last on-treatment visit is the final study visit while the person is still receiving the trial treatment.[1]
This endpoint is meant to show whether the treatment can slow the growth of the damaged area in the retina.[1]
Trial status and size
The study status is listed as Authorised.[1]
The planned enrollment is 155 participants, which means the study aims to include 155 people in total.[1]
The intervention list includes GAL-101 salt and a matching placebo made to have the same osmolarity, which means the fluid balance is adjusted to be similar between groups.[1]
