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

Novartis

Status and phase: Enrolling; Phase 2

Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration

Treatments: Drug: FWY003; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07441642

CFWY003A12201

Details and patient eligibility

About

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

Full 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.

Enrollment: 272 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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272 participants in 4 patient groups, including a placebo group

FWY003 dose level 1

Experimental group

Description:

Participants will receive FWY003 dose level 1

Treatment:

Drug: FWY003

FWY003 dose level 2

Experimental group

Description:

Participants will receive FWY003 dose level 2

Treatment:

Drug: FWY003

FWY003 dose level 3

Experimental group

Description:

Participants will receive FWY003 dose level 3

Treatment:

Drug: FWY003

Placebo

Placebo Comparator group

Description:

Participants will receive placebo

Treatment:

Drug: Placebo