A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD

Conditions

• Geographic Atrophy of the Macula

Eligibility Criteria

Sex

ALL

Age

55 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GAL-101 — DRUG
  Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
• Placebo — DRUG
  Patient will apply daily 2 eye drops of Placebo at 5 minutes interval

Study Details

Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the growth of GA and prevent it from reaching the fovea. GAL-101 is given as eyedrops. eDREAM patients will administer study eyedrops every day. Patients will be assigned by chance (randomly) to receive either eye-drops that contain the new medication, GAL-101, or eyedrops without the active drug (Placebo). Neither patients nor doctors will know which treatment was assigned to each patient until the end of the study.

Key Dates

Start date

Jan 10, 2025

Status verified

Feb 2026

Primary completion

Mar 30, 2027

Completion

May 30, 2027

Study Design

Enrollment

110 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: GAL-101 ophthalmic solution
  Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
• Placebo Comparator: Placebo
  Patient will apply daily 2 eye drops ofPlacebo at 5 minutes interval

Primary Outcome Measure

Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size. [ Time Frame: From baseline to last on-treatment visit (48 up to 96 weeks) ]

Central Contacts

• Galimedix Inc. c/o Imperial CRS, MD
  +1 (301) 9179191
  [email protected]
• Luciana Summo, PhD
  [email protected]

Locations (3)

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