A clinical trial to learn more about the effects of FWY003 in people with geographic atrophy associated with age-related macular degeneration.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Decision date (initial)

2026-05-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG

External identifiers

EU CT number

2025-523704-77-00

WHO UTN

U1111-1333-0893

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Safety, Therapy, Efficacy, Dose response

To evaluate the dose response relationship of FWY003 on GA lesion area in participants with GA secondary to AMD

Secondary objectives 6

1. To assess the safety and tolerability of FWY003
2. To assess the effect of FWY003 on visual function in the study eye from Baseline through Month 18
3. To assess the effect of FWY003 on photoreceptor parameters from Baseline through Month 18.
4. To assess FWY003 pharmacokinetics from Baseline through Month 18.
5. To assess the rate of change in GA lesion area from Baseline through Month 18.
6. To assess the effect of FWY003 on GA lesion area from baseline through Month 00

Conditions and MedDRA coding

Geographic atrophy secondary to age-related macular degeneration

Regulatory references

Scientific advice from competent authorities

National Agency For The Safety Of Medicine And Health Products, Swedish Medical Products Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan 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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Male or female participants ≥ 50 years of age.
2. A diagnosis of GA secondary to AMD in at least one eye (study eye) MUST meet the following criteria with lesion size assessed by FAF. 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 with 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
3. ETDRS BCVA ≥ 35 letters (20/200) in the study eye.

Exclusion criteria 6

1. 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.
2. Intravitreal drug delivery of a complement inhibitor in either eye in the past 3 months or 5 half-lives from screening (whichever is longer). The study eye should not have received ≥6 doses of intravitreally administered anti-complement therapies.
3. Previous cell or gene therapy in either eye.
4. Macular atrophy in either eye due to a cause other than AMD, such as Stargardt disease, cone rod dystrophy, toxic maculopathies, etc.
5. Intraocular surgery, including cataract and vitreoretinal surgery, in the study eye within 3 months prior to Baseline.
6. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change of GA lesion area from Baseline to Month 18

Secondary endpoints 5

1. Incidence and severity of ocular and non-ocular AEs, and systemic safety measures including physical examinations, vital signs, ECG and laboratory tests.
2. Change in visual function in the study eye from Baseline through Month 18 as measured by: • Early treatment diabetic retinopathy study (ETDRS) (Regular Luminance) Best Corrected Visual Acuity (BCVA) • ETDRS Low Luminance Visual Acuity (LLVA) • Quantitative contrast sensitivity function (qCSF) under regular luminance • Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance • LCqVA under low luminance • Proportion of participants with ≥15 letters loss from baseline
3. Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula from Baseline through Month 18
4. Rate of change of GA lesion area (square-root transformed) in the study eye from Baseline through Month 18
5. Change of GA lesion area (square-root transformed) from Baseline through Month 00.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 14

Locations

9 EU/EEA countries · 30 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 104 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications