A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Part of paid clinical trials in Huntington Beach, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07441642
Phase
PHASE2
Status
Recruiting
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Conditions

  • Geographic Atrophy Secondary to Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FWY003 — DRUG
    FWY003 arm participants will receive a specific dose of FWY003
  • Placebo — DRUG
    Placebo arm participants will receive placebo

Study Details

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

Key Dates

Start date
Mar 9, 2026
Status verified
Jun 2026
Primary completion
Aug 21, 2029
Completion
Aug 22, 2029

Study Design

Enrollment
272 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change of geographic atrophy (GA) lesion area [ Time Frame: From Baseline to Month 18 ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (12)

FacilityCityStateZIPSite coordinators
Salehi Retina InstituteHuntington BeachCalifornia92647
Gillian Nguyen
[email protected]
657-227-9496
Hani Salehi-Had (PRINCIPAL_INVESTIGATOR)
Retinal Consultants Medical Group IncSacramentoCalifornia95841
Daniel Ortiz
[email protected]
916-339-3655
Margaret Chang. (PRINCIPAL_INVESTIGATOR)
California Retina ConsultantsSanta BarbaraCalifornia93103
Muskaan Kaur Bal
[email protected]
+1 805 963 1648
Dante Pieramici (PRINCIPAL_INVESTIGATOR)
Advanced Research LLCBoynton BeachFlorida33437
Alayka Reddy
[email protected]
Drew Philip Bawcombe (PRINCIPAL_INVESTIGATOR)
Advanced Research LLCDeerfield BeachFlorida33064
Isabella Villalonga
[email protected]
954-204-0052
Shailesh Gupta (PRINCIPAL_INVESTIGATOR)
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33711
Logan Wilson
[email protected]
727-323-0077
David Eichenbaum (PRINCIPAL_INVESTIGATOR)
Opthamalic Consultants of BostonBostonMassachusetts02114
Hanna Raymond
[email protected]
617-314-2636
Jeffrey S Heier (PRINCIPAL_INVESTIGATOR)
NJ RetinaToms RiverNew Jersey08755
Andy Merino
[email protected]
732-906-1887
Howard Fine (PRINCIPAL_INVESTIGATOR)
Erie Retina Research LLCEriePennsylvania16505
David Almeida (PRINCIPAL_INVESTIGATOR)
Retina Consultants TX Rsrch CtrBellaireTexas77401
MaryGrace Powers
[email protected]
713-524-3434
David M Brown (PRINCIPAL_INVESTIGATOR)
Retina Consultants of Houston PAHoustonTexas77030
Erin Shelato
[email protected]
Charles C Wykoff (PRINCIPAL_INVESTIGATOR)
Retina Consultants of TexasKatyTexas77494
Kymmia Majedi
[email protected]
Kenneth Fan (PRINCIPAL_INVESTIGATOR)

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Salehi Retina Institute· Huntington Beach, CARetinal Consultants Medical Group Inc· Sacramento, CACalifornia Retina Consultants· Santa Barbara, CAAdvanced Research LLC· Boynton Beach, FLAdvanced Research LLC· Deerfield Beach, FLRetina Vitreous Associates of Florida· St. Petersburg, FL

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