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PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing FWY003 for Geographic Atrophy Secondary to Age-related Macular Degeneration

To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Official registry: https://clinicaltrials.gov/study/NCT07441642 · Novartis Pharmaceuticals · enrollment listed as 272

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 FWY003, or Placebo. The registry lists allocation as randomized. To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

They plan to enroll about 272 people at 63 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized, Double Masked, Placebo-controlled, Multicenter, Dose-range Finding Study to Assess the Efficacy and Safety of FWY003 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

Interventions: FWY003, Placebo

Primary outcome (registry wording): Change of geographic atrophy (GA) lesion area in the study eye

Who it is for (from inclusion criteria)

  • Ages 50 Years to any
  • Male or female participants ≥ 50 years of age
  • A diagnosis of GA secondary to AMD in at least one eye (study eye). If both eyes qualify, then the eye with the better BCVA would be assigned as study eye
  • Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively)
  • If GA lesion is multifocal, then the total lesion area must be between 2.5-17.5 mm2 and at least one lesion should have an area of at least 1.25 mm2
  • Entire GA lesion must be visualized on the macula centered image and not contiguous with peripapillary atrophy
  • ETDRS BCVA ≥ 35 letters (20/200) in the study eye

Public study contact (from the registry)

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

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

Sites listed on ClinicalTrials.gov

63 listed

+ 47 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07441642 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 NCT07441642?

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 NCT07441642?

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