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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing GAL-101 for Geographic Atrophy of the Macula

Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina.

Official registry: https://clinicaltrials.gov/study/NCT06659549 · Galimedix Therapeutics Inc · enrollment listed as 110

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are GAL-101, or Placebo. The registry lists allocation as randomized. Age-related macular degeneration (AMD) affects millions of elderly patients.

They plan to enroll about 110 people at 24 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: GAL-101, Placebo

Primary outcome (registry wording): Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size.

Who it is for (from inclusion criteria)

  • Ages 55 Years to any
  • Willing and able to comply with the study schedule and study assessments
  • Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution
  • BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20/100 Snellen equivalent). Criterion will be confirmed at Baseline
  • Refractive error between +3 and -6 diopters spherical equivalent in the study eye
  • Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in the opinion of the Investigator. Criterion will be confirmed at Baseline
  • Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as confirmed by the reading center
  • Well-delineated cumulative GA area between 1.25 and 12.0 mm2

Public study contact (from the registry)

Galimedix Inc. c/o Imperial CRS, MD

+1 (301) 9179191

info@galimedix.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

24 listed

+ 21 sites outside the US on the same record

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NCT01432847 · Official ClinicalTrials.gov record · National Eye Institute (NEI)

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Phase 3: testing PDS Implant with Ranibizumab 100 mg/mL for Neovascular Age-Related Macular Degeneration

This study will measure the long-term whether it is safe and how hard side effects are to live with of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomly assigned in WR42221.

NCT03683251 · Official ClinicalTrials.gov record · Hoffmann-La Roche

FAQ about this NCT record

Is NCT06659549 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06659549?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06659549?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary