Geographic Atrophy Secondary to Age-related Macular DegenerationPhase 2NCT07441642
A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
A Phase 2 study testing FWY003 in people with Geographic Atrophy Secondary to Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 59 sites in 18 countries.
Trial summary
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy Secondary to Age-related Macular Degeneration
- What is being tested?
- FWY003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 59 sitesin 18 countries
- Study dates
- 9 Mar 2026to 22 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively)
- 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
- 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.
Who cannot join
- A history of, or current evidence of, choroidal neovascularization (exudative MNV) in the study eye.
- 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 which in the opinion of the Reading Center could interfere with the assessment of study images.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
59 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
59 sites in 18 countries
United States15 sites, 15 recruiting
- Recruiting
Retina Consultants TX Rsrch Ctr
Bellaire, Texas, 77401
MaryGrace Powers, +1 713 524 3434, marygrace.powers@retinaconsultantstexas.com
David M Brown
- Recruiting
Opthamalic Consultants of Boston
Boston, Massachusetts, 02114
Haylie Carlon, +1 617 314 2636, hcarlon@eyeboston.com
Jeffrey S Heier
- Recruiting
Advanced Research LLC
Boynton Beach, Florida, 33437
Alayka Reddy, areddy@advancedresearchfl.com
Drew Philip Bawcombe
- Recruiting
Advanced Research LLC
Deerfield Beach, Florida, 33064
Quacian Dennis, +1 954 204 0052, qdennis@advancedresearchfl.com
Shailesh Gupta
- Recruiting
Erie Retina Research LLC
Erie, Pennsylvania, 16505
Jade Horn, jhorn@erieretinaresearch.com
David Almeida
- Recruiting
Retina Consultants of Houston PA
Houston, Texas, 77030
Erin Shelato, erin.shelato@retinaconsultantstexas.com
Charles C Wykoff
- Recruiting
Salehi Retina Institute
Huntington Beach, California, 92647
Gillian Nguyen, +1 657 227 9496, g.nguyen@retinasocal.com
Hani Salehi-Had
- Recruiting
Retina Consultants of Texas
Katy, Texas, 77494
Kymmia Majedi, kymmia.majedi@retinaconsultantstexas.com
Kenneth Fan
- Recruiting
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10003
Katy Tai, +1 212 979 4251, ktai@nyee.edu
Richard Rosen
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Sokleab Em, +1 212 305 6361, se2389@cumc.columbia.edu
Tongalp Tezel
- Recruiting
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Angelique Ortiz, +1 800 331 6634, asortiz@midatlanticretina.com
Carl Regillo
- Recruiting
Retinal Consultants Medical Group Inc
Sacramento, California, 95841
Daniel Ortiz, +1 916 339 3655, ortizd@retinalmd.com
Margaret Chang
- Recruiting
California Retina Consultants
Santa Barbara, California, 93103
Muskaan Kaur Bal, +1 805 963 1648, muskaanb@californiaretina.com
Dante Pieramici
- Recruiting
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
Logan Wilson, +1 727 323 0077, lwilson@rvaf.com
David Eichenbaum
- Recruiting
NJ Retina
Toms River, New Jersey, 08755
Andy Merino, +1 732 906 1887, amerino@njretina.com
Howard Fine
Australia4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Albury, New South Wales, 2640
- Recruiting
Novartis Investigative Site
East Melbourne, Victoria, 3002
- Recruiting
Novartis Investigative Site
Parramatta, New South Wales, 2150
- Recruiting
Novartis Investigative Site
Strathfield, New South Wales, 2135
France4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Créteil, 94000
- Recruiting
Novartis Investigative Site
Dijon, 21000
- Recruiting
Novartis Investigative Site
Lyon, Rhone, 69004
- Recruiting
Novartis Investigative Site
Paris, 75940
Germany4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Bonn, 53105
- Recruiting
Novartis Investigative Site
Ludwigshafen, Germany, 67063
- Recruiting
Novartis Investigative Site
Münster, 48145
- Recruiting
Novartis Investigative Site
Tübingen, 72076
Italy4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Florence, FI, 50134
- Recruiting
Novartis Investigative Site
Milan, MI, 20122
- Recruiting
Novartis Investigative Site
Milan, MI, 20132
- Recruiting
Novartis Investigative Site
Roma, RM, 00184
Spain4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Burjassot, Valencia, 46100
- Recruiting
Novartis Investigative Site
Córdoba, 14012
- Recruiting
Novartis Investigative Site
Sant Cugat Del V, Barcelona, 08190
- Recruiting
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
United Kingdom4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Bristol, BS1 2LX
- Recruiting
Novartis Investigative Site
London, NW10 7NS
- Recruiting
Novartis Investigative Site
Newcastle upon Tyne, NE1 4LP
- Recruiting
Novartis Investigative Site
Southampton, SO16 6YD
Hungary3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Budapest, 1083
- Recruiting
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
- Recruiting
Novartis Investigative Site
Pécs, Baranya, 7621
Japan3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138655
- Recruiting
Novartis Investigative Site
Chiyoda-ku, Tokyo, 1018309
- Recruiting
Novartis Investigative Site
Kobe, Hyōgo, 6500047
Brazil2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Blumenau, Santa Catarina, 89010-204
- Recruiting
Novartis Investigative Site
Serra, Espírito Santo, 29160-750
Canada2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
London, Ontario, N6A 4L8
- Recruiting
Novartis Investigative Site
Ottawa, Ontario, K2B 7E9
Czechia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Prague, 100 34
- Recruiting
Novartis Investigative Site
Prague, 128 08
Poland2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-631
- Recruiting
Novartis Investigative Site
Krakow, 31-070
Romania2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Bucharest, 011658
- Recruiting
Novartis Investigative Site
Cluj-Napoca, Cluj, 400006
Argentina1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Caba, C1056
Bulgaria1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Sofia, 1618
Colombia1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Barranquilla, Atlántico, 080001
Puerto Rico1 site, 1 recruiting
- Recruiting
Emanuelli Research and Development Center LLC
Arecibo, 00612
Diane Perez Perez, +1 787 879 7722, dperez@erdpr.com
Andres Emanuelli Anzalotta
About this study
Official title: A Randomized, Double Masked, Placebo-controlled, Multicenter, Dose-range Finding Study to Assess the Efficacy and Safety of FWY003 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Read the 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.
- Being tested
- FWY003, Placebo
- Keywords
- FWY003, safety, tolerability, geographical atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FWY003Drug
FWY003 arm participants will receive a specific dose of FWY003
PlaceboDrug
Placebo arm participants will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| FWY003 dose level 1 | Experimental | Participants will receive FWY003 dose level 1 Receives: Drug: FWY003 |
| FWY003 dose level 2 | Experimental | Participants will receive FWY003 dose level 2 Receives: Drug: FWY003 |
| FWY003 dose level 3 | Experimental | Participants will receive FWY003 dose level 3 Receives: Drug: FWY003 |
| Placebo | Placebo comparator | Participants will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of geographic atrophy (GA) lesion area in the study eye
To evaluate the dose response relationship of FWY003 on GA lesion area in the study eye in participants with GA secondary to age-related macular degeneration (AMD).
Measured: From Baseline to Month 18
Secondary outcomes (11)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of FWY003.
Measured: From first dose (Day 1) to Month 19
Change in visual function measure by ETDRS (Regular Luminance) Best Corrected Visual Acuity (BCVA) in the study eye
To assess the change in visual function over time by measuring Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart under normal lighting conditions. BCVA is the sharpest vision a person can achieve with optimal correction, such as glasses or contact lenses. The ETDRS eye chart is the standardized chart used in clinical trials.
Measured: Baseline through Month 18
Change in visual function measure by ETDRS Low Luminance Visual Acuity (LLVA) in the study eye
To assess the change in visual function using Early Treatment Diabetic Retinopathy Study (ETDRS) Low Luminance Visual Acuity (LLVA) vision test. This test measures how well a person can see under low-light conditions. It is performed using the standard ETDRS eye chart.
Measured: Baseline through Month 18
Change in visual function measure by Quantitative contrast sensitivity function (qCSF) under regular luminance in the study eye
To assess the change in visual function by using a test called the quantitative Contrast Sensitivity Function (qCSF). qCSF checks how faint a pattern a person can see, and how that changes for large vs. small details.
Measured: Baseline through Month 18
Change in visual function measure by Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance in the study eye
To assess the change in visual function using a test called Low Contrast quantitative Visual Acuity (LCqVA). LCqVA is visual acuity test where letters on the chart are printed with reduced contrast. The test is performed in normal lighting conditions.
Measured: Baseline through Month 18
Change in visual function measure by LCqVA under low luminance in the study eye
To assess the change in visual function in dim-light conditions using a test called Low Contrast quantitative Visual Acuity (LCqVA). This test measures how well a person can read low-contrast letters. The test is performed with reduced luminance (making the environment darker).
Measured: Baseline through Month 18
Proportion of participants with ≥15 letters loss
To measure how many participants in a study lose 15 or more letters on a visual test
Measured: Baseline through Month 18
Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula in the study eye
To assess the effect of FWY003 on photoreceptor parameters in the study eye.
Measured: Baseline through Month 18
Plasma concentrations of FWY003
To assess the pharmacokinetic profile of FWY003.
Measured: Baseline through Month 18
Rate of change of GA lesion area (square-root transformed) in the study eye
To assess the rate of change in GA lesion area in the study eye.
Measured: Baseline through Month 18
Change of GA lesion area (square-root transformed)
To assess the effect of FWY003 on GA lesion area.
Measured: Baseline through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start9 Mar 2026
- Primary completion21 Aug 2029 (estimated)
- Study completion22 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic Atrophy Secondary to Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441642
- Sponsor's protocol ID
- CFWY003A12201
- Status last verified
- Oct 2026
- First submitted
- 24 Feb 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Masked, Placebo-controlled, Multicenter, Dose-range Finding Study to Assess the Efficacy and Safety of FWY003 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07441642
- Acronym / sponsor ID
- CFWY003A12201
- Keywords
- FWY003, safety, tolerability, geographical atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 21 Aug 2029 (estimated)
- Study completion
- 22 Aug 2029 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FWY003 dose level 1 | Experimental | Drug: FWY003Participants will receive FWY003 dose level 1 |
| FWY003 dose level 2 | Experimental | Drug: FWY003Participants will receive FWY003 dose level 2 |
| FWY003 dose level 3 | Experimental | Drug: FWY003Participants will receive FWY003 dose level 3 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- ETDRS BCVA ≥ 35 letters (20/200) in the study eye.
Key exclusion criteria (6 listed)
- A history of, or current evidence of, choroidal neovascularization (exudative MNV) in the study eye.
- 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 which in the opinion of the Reading Center could interfere with the assessment of study images.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FWY003FWY003 arm participants will receive a specific dose of FWY003 | Drug | FWY003 dose level 1, FWY003 dose level 2, FWY003 dose level 3 |
| PlaceboPlacebo arm participants will receive placebo | Drug | Placebo |
Primary outcome
Change of geographic atrophy (GA) lesion area in the study eye
Time frame: From Baseline to Month 18
To evaluate the dose response relationship of FWY003 on GA lesion area in the study eye in participants with GA secondary to age-related macular degeneration (AMD).
11 secondary outcomes
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: From first dose (Day 1) to Month 19
Change in visual function measure by ETDRS (Regular Luminance) Best Corrected Visual Acuity (BCVA) in the study eye
Time frame: Baseline through Month 18
Change in visual function measure by ETDRS Low Luminance Visual Acuity (LLVA) in the study eye
Time frame: Baseline through Month 18
Change in visual function measure by Quantitative contrast sensitivity function (qCSF) under regular luminance in the study eye
Time frame: Baseline through Month 18
Change in visual function measure by Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance in the study eye
Time frame: Baseline through Month 18
Change in visual function measure by LCqVA under low luminance in the study eye
Time frame: Baseline through Month 18
Proportion of participants with ≥15 letters loss
Time frame: Baseline through Month 18
Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula in the study eye
Time frame: Baseline through Month 18
Plasma concentrations of FWY003
Time frame: Baseline through Month 18
Rate of change of GA lesion area (square-root transformed) in the study eye
Time frame: Baseline through Month 18
Change of GA lesion area (square-root transformed)
Time frame: Baseline through Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
59 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FWY003 in people with Geographic Atrophy Secondary to Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 59 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Australia, France, Germany, Italy and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of geographic atrophy (GA) lesion area in the study eye (time frame: From Baseline to Month 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.