Geographic Atrophy Clinical Trials

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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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

∙ 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.

Locations
United States
California
Salehi Retina Institute
RECRUITING
Huntington Beach
Florida
Advanced Research LLC
RECRUITING
Boynton Beach
Advanced Research LLC
RECRUITING
Deerfield Beach
Retina Vitreous Associates of Florida
RECRUITING
St. Petersburg
Massachusetts
Opthamalic Consultants of Boston
RECRUITING
Boston
Other Locations
Australia
Novartis Investigative Site
RECRUITING
Albury
Novartis Investigative Site
RECRUITING
Parramatta
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2026-03-09
Estimated Completion Date: 2029-08-22
Participants
Target number of participants: 272
Treatments
Experimental: FWY003 dose level 1
Participants will receive FWY003 dose level 1
Experimental: FWY003 dose level 2
Participants will receive FWY003 dose level 2
Experimental: FWY003 dose level 3
Participants will receive FWY003 dose level 3
Placebo_comparator: Placebo
Participants will receive placebo
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov