A Study to Investigate Efficacy and Safety of FWY003 Comp... | NCT07441642

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

NCT07441642

Sponsor

Novartis Pharmaceuticals

Status

Recruiting

Last Update Posted

Jul 9, 2026Actual

Enrollment

272Estimated

Phase

Phase 2

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Interventions

FWY003
Placebo

Countries

United States
Australia
Bulgaria
Canada
Czechia
France
Germany
Hungary
Italy
Japan
Poland
Puerto Rico
Romania
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2026Actual

Primary Completion Date

Aug 21, 2029Estimated

Completion Date

Aug 22, 2029Estimated

First Submitted Date

Feb 24, 2026

First Submission Date that Met QC Criteria

Feb 24, 2026

First Posted Date

Mar 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2026

Last Update Posted Date

Jul 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

272Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FWY003 dose level 1	Experimental	Participants will receive FWY003 dose level 1	Drug: FWY003
FWY003 dose level 2	Experimental	Participants will receive FWY003 dose level 2	Drug: FWY003
FWY003 dose level 3	Experimental	Participants will receive FWY003 dose level 3	Drug: FWY003
Placebo	Placebo Comparator	Participants will receive placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FWY003	Drug	FWY003 arm participants will receive a specific dose of FWY003	FWY003 dose level 1 FWY003 dose level 2 FWY003 dose level 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of geographic atrophy (GA) lesion area	To evaluate the dose response relationship of FWY003 on GA lesion area in participants with GA secondary to age-related macular degeneration (AMD).	From Baseline to Month 18

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events (AEs) and serious adverse events (SAEs)	To assess the safety and tolerability of FWY003.	From first dose (Day 1) to Month 19
Change in visual function measure by ETDRS (Regular Luminance) Best Corrected Visual Acuity (BCVA)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Novartis Pharmaceuticals	Contact	1-888-669-6682		novartis.email@novartis.com
Novartis Pharmaceuticals	Contact	+41613241111

Facility	Status	City	State	ZIP	Country	Contacts
Salehi Retina Institute	Recruiting	Huntington Beach	California	92647	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided