Actively Recruiting
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
Led by Novartis Pharmaceuticals · Updated on 2026-06-08
272
Participants Needed
28
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the dose response, effectiveness, and safety of FWY003 in people with geographic atrophy (GA) caused by age-related macular degeneration (AMD). This randomized, multi-center, double-masked study aims to understand how different doses of FWY003 affect GA progression. The study is sponsored by Novartis Pharmaceuticals and focuses on adults aged 50 and older with GA secondary to AMD. Participants are randomly assigned to receive one of three different dose levels of FWY003 or a placebo. Treatment is administered under controlled conditions without participants or staff knowing the assigned group to ensure unbiased results. The study will assess changes in GA lesion area and various measures of visual function over an 18-month period. During the study, participants will undergo regular eye exams and imaging to measure GA lesion size and visual acuity using standardized tests such as ETDRS Best Corrected Visual Acuity and low luminance visual acuity. Safety will be monitored by recording any adverse events from the first dose through month 19. Blood samples will be collected to measure FWY003 levels. The total study duration per participant is 18 months with close monitoring throughout.
CONDITIONS
Brief Title
A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants 50 years of age or older
- Diagnosis of geographic atrophy secondary to age-related macular degeneration in at least one eye
- Total geographic atrophy lesion area between 2.5 and 17.5 mm2
- For multifocal lesions, total area between 2.5 and 17.5 mm2 with at least one lesion of 1.25 mm2 or larger
- Entire lesion must be visible on macula-centered image and not connected to peripapillary atrophy
- Best corrected visual acuity (BCVA) in the study eye of at least 35 letters (20/200 vision or better)
You will not qualify if you...
- History or current evidence of choroidal neovascularization (exudative macular neovascularization) in either eye
- Previous cell or gene therapy in either eye
- Macular atrophy caused by conditions other than age-related macular degeneration
- Intraocular surgery in the study eye within 3 months before baseline
- Significant media opacity, eye movement disorder, severe ptosis, extraocular motility restriction, or head tremor interfering with fundus visualization or retinal imaging
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 18 months
Participants receive FWY003 or placebo to assess efficacy and safety in geographic atrophy secondary to age-related macular degeneration.
Regular visits during treatment period (visit frequency not specified)
Trial Site Locations
Total: 28 locations
1
Salehi Retina Institute
Huntington Beach, California, United States, 92647
Actively Recruiting
2
Retinal Consultants Medical Group Inc
Sacramento, California, United States, 95841
Actively Recruiting
3
California Retina Consultants
Santa Barbara, California, United States, 93103
Actively Recruiting
4
Advanced Research LLC
Boynton Beach, Florida, United States, 33437
Actively Recruiting
5
Advanced Research LLC
Deerfield Beach, Florida, United States, 33064
Actively Recruiting
6
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States, 33711
Actively Recruiting
7
Opthamalic Consultants of Boston
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
NJ Retina
Toms River, New Jersey, United States, 08755
Actively Recruiting
9
Erie Retina Research LLC
Erie, Pennsylvania, United States, 16505
Actively Recruiting
10
Retina Consultants TX Rsrch Ctr
Bellaire, Texas, United States, 77401
Actively Recruiting
11
Retina Consultants of Houston PA
Houston, Texas, United States, 77030
Actively Recruiting
12
Retina Consultants of Texas
Katy, Texas, United States, 77494
Actively Recruiting
13
Novartis Investigative Site
Albury, New South Wales, Australia, 2640
Actively Recruiting
14
Novartis Investigative Site
Parramatta, New South Wales, Australia, 2150
Actively Recruiting
15
Novartis Investigative Site
Strathfield, New South Wales, Australia, 2135
Actively Recruiting
16
Novartis Investigative Site
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
17
Novartis Investigative Site
Sofia, Bulgaria, 1618
Actively Recruiting
18
Novartis Investigative Site
Ottawa, Ontario, Canada, K2B 7E9
Actively Recruiting
19
Novartis Investigative Site
Prague, Czechia, 128 08
Actively Recruiting
20
Novartis Investigative Site
Créteil, France, 94000
Actively Recruiting
21
Novartis Investigative Site
Bonn, Germany, 53105
Actively Recruiting
22
Novartis Investigative Site
Pécs, Baranya, Hungary, 7621
Actively Recruiting
23
Novartis Investigative Site
Milan, MI, Italy, 20132
Actively Recruiting
24
Novartis Investigative Site
Roma, RM, Italy, 00184
Actively Recruiting
25
Novartis Investigative Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85 631
Actively Recruiting
26
Novartis Investigative Site
Krakow, Poland, 31-070
Actively Recruiting
27
Novartis Investigative Site
Bucharest, Romania, 011658
Actively Recruiting
28
Novartis Investigative Site
Burjassot, Valencia, Spain, 46100
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here