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A phase 2, double-masked, randomized, multicenter, parallel group, placebo-controlled study to investigate the efficacy and safety of GAL-101, 2%, ophthalmic solution in patients with non-foveal geographic atrophy secondary to non-neovascular age-related macular degeneration: eDREAM study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519128-26-00
Acronym
GAL-101-C0201
Enrollment
65
Registered
2025-04-04
Start date
2025-05-22
Completion date
Unknown
Last updated
2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-foveal geographic atrophy secondary to non-neovascular age-related macular degeneration

Brief summary

Comparision between groups of annual rate of change in the area of GA as measured by fundus autofluorescence (FAF) (Baseline to last on-treatment visit)

Detailed description

Comparision between groups of annual rate of change in the area of PRD as measured by optical coherence tomography (OCT) (Baseline to last on-treatment visit), Comparision between groups of annual rate of change in mean sensitivity of grid points using mesopic microperimetry (MP) (Baseline to last on-treatment visit)

Interventions

DRUGGAL-101 ophtalmic solution matching placebo. It contains the excipients as GAL-101 ophtalmic solution plus Sodium Chloride instead of the API
DRUGwhich allows to achieve the same osmolarity as GAL-101 ophtalmic solution

Sponsors

Galimedix Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Comparision between groups of annual rate of change in the area of GA as measured by fundus autofluorescence (FAF) (Baseline to last on-treatment visit)

Secondary

MeasureTime frame
Comparision between groups of annual rate of change in the area of PRD as measured by optical coherence tomography (OCT) (Baseline to last on-treatment visit), Comparision between groups of annual rate of change in mean sensitivity of grid points using mesopic microperimetry (MP) (Baseline to last on-treatment visit)

Countries

France, Germany, Ireland, Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026