Clinical trial • Phase II • Ophthalmology

FWY003 TOSILATE for Geographic atrophy secondary to age-related macular degeneration | Dry age-related macular degeneration

Phase II trial of FWY003 TOSILATE for Geographic atrophy secondary to age-related macular degeneration | Dry age-related macular degeneration.

Overview

Trial Therapeutic Area
Ophthalmology
Trial Disease
Geographic atrophy secondary to age-related macular degeneration | Dry age-related macular degeneration
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
13-01-2026
First CTIS Authorization Date
04-05-2026

Trial design

Randomised, placebo to fwy003; dose/schedule not specified in the available record-controlled Phase II trial in Bulgaria, Czechia, France and others.

Randomised
Yes
Comparator
Placebo to FWY003; dose/schedule not specified in the available record
Target Sample Size
130
Trial Duration For Participant
540

Eligibility

Recruits 130 adults.

Inclusion criteria

  • {"criterion_text":"- Male or female participants ≥ 50 years of age.\n- 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\n- ETDRS BCVA ≥ 35 letters (20/200) in the study eye."}

Exclusion criteria

  • {"criterion_text":"- 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.\n- 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.\n- Previous cell or gene therapy in either eye.\n- Macular atrophy in either eye due to a cause other than AMD, such as Stargardt disease, cone rod dystrophy, toxic maculopathies, etc.\n- Intraocular surgery, including cataract and vitreoretinal surgery, in the study eye within 3 months prior to Baseline.\n- 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 endpoints

  • {"endpoint_text":"- Change of GA lesion area from Baseline to Month 18","definition_or_measurement_approach":"Change of GA lesion area from Baseline to Month 18 measured by fundus autofluorescence (FAF)."}

Secondary endpoints

  • {"endpoint_text":"- Incidence and severity of ocular and non-ocular AEs, and systemic safety measures including physical examinations, vital signs, ECG and laboratory tests.\n- 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\n- Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula from Baseline through Month 18\n- Rate of change of GA lesion area (square-root transformed) in the study eye from Baseline through Month 18\n- Change of GA lesion area (square-root transformed) from Baseline through Month 00.","definition_or_measurement_approach":"1) Safety endpoints: incidence/severity of ocular and non-ocular AEs; systemic safety via physical examinations, vital signs, ECG, laboratory tests.\n2) Visual function endpoints: measured using ETDRS BCVA (regular luminance), ETDRS LLVA, quantitative contrast sensitivity function (qCSF), LCqVA (regular and low luminance); proportion with ≥15 letter loss from baseline.\n3) EZ attenuation: measured by optical coherence tomography (OCT).\n4) GA lesion area rate of change: square-root transformation applied; measured by FAF.\n5) GA lesion area change (square-root transformed): measured by FAF."}

Recruitment

Planned Sample Size
130
Recruitment Window Months
38
Consent Approach
Informed consent is obtained from adult participants using main adult ICF documents. Main ICF and related participant documents are available in multiple country/languages (examples from submitted documents include English, Bulgarian, Czech, French, Hungarian, Italian, Polish, Spanish, Romanian, German). Separate follow-up/pregnancy information sheets and optional assessment/genetics consent forms are provided where indicated. No assent or minor/parental consent materials are provided in the available documentation.

Geography

Total Number Of Sites
30
Total Number Of Participants
142

Bulgaria

Earliest CTIS Part Ii Submission Date
29-01-2026
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
99
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Multispecialty hospital for active treatment Sveta Sofia EOOD
Department Name
3001: Clinic of Ophthalmology Diseases
Contact Person Name
Veronika Bacheva

Czechia

Earliest CTIS Part Ii Submission Date
03-04-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
31
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
3102: Ocni klinika
Contact Person Name
Bohdan Kousal
Contact Person Email
bohdan.kousal@vfn.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
3101: Oftalmologicka klinika
Contact Person Name
Miroslav Veith
Contact Person Email
mveith@email.cz

France

Earliest CTIS Part Ii Submission Date
06-04-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
28
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Fondation A De Rothschild
Department Name
3202: Optalmology
Contact Person Name
Yannick Le Mer
Contact Person Email
ylemer@for.paris
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
3203: Ophtalmology
Contact Person Name
Catherine Creuzot-Garcher
Site Name
Hospices Civils De Lyon
Department Name
3204: Ophtalmology
Contact Person Name
Laurent Kodjikian
Contact Person Email
laurent.kodjikian@chu-lyon.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
3205: Ophtalmology
Contact Person Name
Eric Souied
Contact Person Email
eric.souied@chicreteil.fr
Site Name
Retina
Department Name
3201: Optalmology
Contact Person Name
Hessam Razavi
Contact Person Email
razavisam3@gmaiI.com

Germany

Earliest CTIS Part Ii Submission Date
02-04-2026
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
33
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Department Name
3304: Dept. of Ophthalmology
Contact Person Name
Lars-Olof Hattenbach
Contact Person Email
hattenbach.lo@klilu.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
3301: Dept. of Ophthalmology
Contact Person Name
Kristina Pfau
Contact Person Email
Kristina.Pfau@ukbonn.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
3302: Department für Augenheilkunde
Contact Person Name
Lisa Vanessa Strudel
Site Name
Augenzentrum Am St Franziskus-Hospital Muenster
Department Name
3303
Contact Person Name
Georg Spital

Hungary

Earliest CTIS Part Ii Submission Date
29-01-2026
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
99
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
3404: Dep. Of Ophthalmology
Contact Person Name
Gabor Vogt
Contact Person Email
gabor.vogt@tosho.hu
Site Name
Nozologen Kft.
Department Name
3403
Contact Person Name
Balazs Varsanyi
Contact Person Email
varsanyi.balazs@ganglion.hu
Site Name
Semmelweis University
Department Name
3401: Ophthalmology Clinic
Contact Person Name
Andras Papp
Contact Person Email
papp.andras1@semmelweis.hu
Site Name
Budapest Retina Associates Kft.
Department Name
3405
Contact Person Name
Andras Seres
Contact Person Email
seres@budapestretina.hu
Site Name
University Of Debrecen
Department Name
3402: Ophthalmology Clinic
Contact Person Name
Attila Vajas
Contact Person Email
Vajasa@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
27-03-2026
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
40
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Department Name
3507: U.O.S. Retina Medica
Contact Person Name
Mariacristina Parravano
Contact Person Email
mcparravano@gmail.com
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
3502: S.O.D. Oculistica
Contact Person Name
Fabrizio Giansanti
Contact Person Email
fabrizio.giansanti@unifi.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
3505: U.O. Oculistica Padiglione Monteggia
Contact Person Name
Francesco Viola
Contact Person Email
francesco.viola@uni.mi.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
3504: U.O. di Oculistica
Contact Person Name
Francesco Bandello
Contact Person Email
bandello.francesco@hsr.it

Romania

Earliest CTIS Part Ii Submission Date
02-04-2026
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
36
Number Of Sites
2
Number Of Participants
34

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
3702: Ophthalmology
Contact Person Name
Simona Nicoara
Site Name
Arensia Clinics S.R.L.
Department Name
3701: Ophthalmology
Contact Person Name
Ruxandra Simionescu

Spain

Earliest CTIS Part Ii Submission Date
01-04-2026
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
37
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Metavision Arruzafa S.L.
Department Name
3801: Oftalmología
Contact Person Name
Juan Manuel Cubero Parra
Contact Person Email
jmcubero@hospitalarruzafa.com
Site Name
Instituto Oftalmologico Gomez-Ulla S.L.
Department Name
3805: Oftalmología
Contact Person Name
Maximino Jose Abraldes Lopez-Veiga
Site Name
Hospital Universitari General De Catalunya
Department Name
3804: Oftalmología
Contact Person Name
Laura Sararols Ramsay
Contact Person Email
lsararols@omiq.es
Site Name
Oftalmologia Vistahermosa S.L.
Department Name
3803: Oftalmología
Contact Person Name
Roberto Gallego Pinazo
Contact Person Email
robertogallegopinazo@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
02-04-2026
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
34
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Oftalmika Sp. z o.o.
Department Name
3604: Ophthalmology
Contact Person Name
Jakub Kałużny
Contact Person Email
jjkaluzny@oftalmika.pl
Site Name
Centrum Medyczne Dietla 19 Sp. z o.o.
Department Name
3602: Ophthalmology
Contact Person Name
Piotr Oleksy
Contact Person Email
Piotroleksy@yahoo.pl
Site Name
Caminomed Sp. z o.o.
Department Name
3605: Ophthalmology
Contact Person Name
Wojciech Jędrzejewski

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
code 1
Name
Parexel International (IRL) Limited
Responsibilities
code 12
Name
IQVIA Limited
Responsibilities
codes 1,13,3,4
Name
Syneos Health Inc.
Responsibilities
code 1
Name
Veeda Clinical Research Limited
Responsibilities
code 4
Name
Icon Laboratory Services Inc.
Responsibilities
code 4

Third parties

  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"code 15: Provision of ancillary supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"SGS France","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes 1,13,3,4","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Veeda Clinical Research Limited","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Adaptive Sensory Technology Inc.","duties_or_roles":"code 13","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Eurofins Danmark A/S","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Global Eye Trials Limited","duties_or_roles":"code 13","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Duke University","duties_or_roles":"code 13","organisation_type":"Educational Institution"}
  • {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"code 15: Sample storage","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
FWY003
Active Substance
FWY003 TOSILATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Investigational Product Name
Placebo to FWY003
Modality
Other

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