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

Purpose

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

Condition

  • Geographic Atrophy Secondary to Age-related Macular Degeneration

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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. 1. Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively) 2. 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 3. 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.

Exclusion Criteria

  • A history of, or current evidence of, choroidal neovascularization (exudative MNV) in either eye, as determined by the central reading center on multimodal imaging at screening. - Previous cell or gene therapy in either eye. - Macular atrophy in either eye due to a cause other than AMD, such as Stargardt disease, cone rod dystrophy, toxic maculopathies, etc. - Intraocular surgery, including cataract and vitreoretinal surgery, in the study eye within 3 months prior to Baseline. - Presence of significant media opacity, eye movement disorder (nystagmus), severe ptosis, extraocular motility restriction or head tremor, which in the opinion of the investigator, would prevent adequate fundus visualization or interfere with retinal imaging data quality. Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
FWY003 dose level 1
Participants will receive FWY003 dose level 1
  • Drug: FWY003
    FWY003 arm participants will receive a specific dose of FWY003
Experimental
FWY003 dose level 2
Participants will receive FWY003 dose level 2
  • Drug: FWY003
    FWY003 arm participants will receive a specific dose of FWY003
Experimental
FWY003 dose level 3
Participants will receive FWY003 dose level 3
  • Drug: FWY003
    FWY003 arm participants will receive a specific dose of FWY003
Placebo Comparator
Placebo
Participants will receive placebo
  • Drug: Placebo
    Placebo arm participants will receive placebo

Recruiting Locations

Salehi Retina Institute
Huntington Beach, California 92647
Contact:
Gillian Nguyen
657-227-9496
g.nguyen@retinasocal.com

Advanced Research LLC
Boynton Beach, Florida 33437
Contact:
Alayka Reddy
areddy@advancedresearchfl.com

Advanced Research LLC
Deerfield Beach, Florida 33064
Contact:
Isabella Villalonga
954-204-0052
ivillalonga@advancedresearchfl.com

Retina Vitreous Associates of Florida
St. Petersburg, Florida 33711
Contact:
Logan Wilson
727-323-0077
lwilson@rvaf.com

Opthamalic Consultants of Boston
Boston, Massachusetts 02114
Contact:
Hanna Raymond
617-314-2636
hraymond@eyeboston.com

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Detailed Description

This study is designed as a randomized, multi-center, double-masked, prospective study to characterize the dose response relationship, efficacy and safety of FWY003.