A Study in Adults With Geographic Atrophy

NCT07606365 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STL303-202
• Study Type: interventional
• Target: 300
• Locations: 7 countries
• Sites: 60

Brief Summary

The purpose of this clinical research study is to look at how safe STL303 is and whether it works when given to people with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). Geographic atrophy secondary to AMD is a condition where cells in the back part of the eye slowly die, causing a blurry, or missing spot in the centre of vision.

Conditions

Geographic Atrophy

Keywords

Age-Related Macular Degeneration; Geographic Atrophy

Outcome Measures

Primary Outcomes (1)

• Reduction of rate of total EZ area loss

  Rate of change in the area of photoreceptor loss

  From baseline to Week 52

Secondary Outcomes (8)

• Number of reported treatment-emergent adverse events (TEAE) and serious adverse events (SAEs)

  Baseline to week 108

• Change in Retinal sensitivity

  From enrolment to end of treatment at week 104

• Rate of disease progression (photoreceptor loss)

  From enrolment to end of treatment at week 104

• Change in Vision-Related Quality of Life

  From Baseline to end of treatment at week 104

• Maximum serum concertation at steady-state (Cmax, ss) of STL303

  Weeks 0, 4, 12, 26, 52, 78, and 104 pre and 2 hours post dose.

Study Arms (3)

STL303 dose level 1

EXPERIMENTAL

Participants will receive STL303 dose level 1

Drug: STL303

STL303 dose level 2

EXPERIMENTAL

Participants will receive STL303 dose level 2

Drug: STL303

Placebo

PLACEBO COMPARATOR

Participants will receive placebo

Drug: Placebo

Interventions

STL303 DRUG

STL303 arm participants will receive a specific dose of STL303

STL303 dose level 1; STL303 dose level 2

Placebo DRUG

Placebo arm participants will receive placebo

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants ≥60 years of age at the time of Screening (signing the ICF).
• Diagnosis of non-exudative AMD in both eyes, with confirmed presence of phenotypic hallmarks of AMD such as hard and/or soft drusen.
• The GA lesion in the study eye must meet the following criteria as determined by the central Reading Centre's assessment at Screening:
• Total GA area must be ≥2.5 and ≤10.16 mm2 (1 and 4 DA, respectively) as measured using SD-OCT.
• If GA is multifocal, at least one focal lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA, as specified above in 3a.
• The entire GA lesion must be completely visualised on the 6 × 6 mm fovea-centred OCT scan and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
• The entire EZ loss border must be completely visualised on the 6 × 6 mm fovea centred OCT scan as determined by the central Reading Centre's assessment at Screening; in cases where the EZ loss border is close to the grid boundary, a grid centred on the atrophic area may be used at the Baseline visit (as advised by the Reading Centre).
• All GA lesions must be at least 150 μm from foveal centre.
• BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) score of ≥55 letters (Snellen equivalent ≥20/70) in the study eye at the Screening visit and Baseline visit.
• Low luminance visual acuity (LLVA) by ETDRS score of ≥10 letters in the study eye at the Screening visit and Baseline visit.
• Meets the following criteria related to microperimetry:
• Able to detect fixation target.
• Fixation losses must be ≤20%.
• Participant is willing and able to undertake microperimetry assessment in the opinion of the Investigator.
• Able to take IMP or have an appropriate designee who can administer the IMP (i.e., a capable family member or caregiver).

You may not qualify if:

• Atrophic retinal disease of causality other than AMD including myopia-related maculopathy and macular dystrophies such as pattern dystrophy and Stargardt disease in either eye.
• Evidence of ongoing exudative AMD, polypoidal choroidal vasculopathy, or macular neovascularisation in either eye by history, OCT, fluorescein angiography (FA) or optical coherence tomography angiography (OCTA) as determined by the Reading Centre (prior IVT treatment for CNV is permitted in the fellow eye so long as the last injection was more than two years previously).
• Previous treatment with any ocular photodynamic therapy or laser coagulation to the macula in the study eye.
• Presence of active/current retinal vein occlusion in the study eye.
• Presence of vitreous haemorrhage in the study eye.
• History of retinal detachment in the study eye.
• Ocular conditions - either eye:
• Presence of any other retinal pathology that, in the opinion of the Investigator, would confound the diagnosis or assessment of GA or would make follow-up not feasible.
• History of herpetic infection in either eye.
• Active uveitis and/or vitritis (grade trace or above) in either eye.
• History of idiopathic or autoimmune-associated uveitis in either eye.
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
• Spherical equivalent of the refractive error demonstrating \>6 diopters of myopia or an axial length \>26 mm in either eye.
• Intraocular surgery (including lens replacement surgery) within 3 months prior to randomisation in either eye.
• Yttrium Aluminium Garnet (YAG) laser in either eye within 1 month prior to randomisation.

Sponsors & Collaborators

• Sitala Bio LTD: lead

Study Sites (60)

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Kaiser Permanente - Oakland

Oakland, California, 94612, United States

Location

Retina Specialists of Colorado

Aurora, Colorado, 80012, United States

Location

Retina Group of New England, PC

Waterford, Connecticut, 06385, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

Florida Retina Institute

Wildwood, Florida, 34785, United States

Location

University Retina and Macula Associates, P.C.

Lemont, Illinois, 60439, United States

Location

Associated Vitreoretinal and Uveitis Consultants

Carmel, Indiana, 46032, United States

Location

Cumberland Valley Retina Consultants,P.C.

Hagerstown, Maryland, 21740, United States

Location

Mid Atlantic Retina Specialists

Hagerstown, Maryland, 21740, United States

Location

Ophthalmic Consultants of Boston

Waltham, Massachusetts, 02451, United States

Location

Long Island and Queens Vitreoretinal Consultants of NY, P.C.

Hauppauge, New York, 11788, United States

Location

Erie Retina Research

Erie, Pennsylvania, 16507, United States

Location

Tennessee Retina, PC

Nashville, Tennessee, 37203, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Star Vision Research

Burleson, Texas, 76028, United States

Location

Retina Consultants of Texas

Schertz, Texas, 78154, United States

Location

Northeast Wisconsin Retina Associates

Appleton, Wisconsin, 54914, United States

Location

Eye Clinic of Wisconsin

Wausau, Wisconsin, 54403, United States

Location

Buenos Aires Macula S.A

Buenos Aires, Buenos Aires, 1061, Argentina

Location

Centro Medico Viamonte SRL

Buenos Aires, Buenos Aires, C1120AAC, Argentina

Location

Centro de Ojos Quilmes

Quilmes, Buenos Aires, 1878, Argentina

Location

Hospital Britanico de Buenos Aires

Buenos Aires, Ciudad Autonoma Buenos Aires, 1008, Argentina

Location

Instituoto Oftalmologico de Buenos Aires S.A.

Buenos Aires, Ciudad Autonoma Buenos Aires, C1056, Argentina

Location

Centro Oftalmologico Dr. Charles S.A.

Buenos Aires, Ciudad Autonoma Buenos Aires, C1121ABB, Argentina

Location

Centro Privado de Ojos

Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, C1033AAW, Argentina

Location

IMOC Instituto de Microcirugia Ocular Cordoba

Córdoba, Córdoba Province, X5000, Argentina

Location

Centrovision Mendoza SA

Mendoza, Mendoza Province, 5500, Argentina

Location

Centro de la Vision

Salta, Salta Province, 4400, Argentina

Location

Grupo Laser Visión - Rosario Eximer Laser Visión

Rosario, Santa Fe Province, 2000, Argentina

Location

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Sydney West Retina

Westmead, New South Wales, 2145, Australia

Location

Queensland Eye Institute

South Brisbane, Queensland, 4101, Australia

Location

Adelaide Eye and Retina Centre

Adelaide, South Australia, 5000, Australia

Location

Cerulea Pty Ltd

East Melbourne, Victoria, 3002, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

OFTEX, s.r.o.

Pardubice, Prague, 530 02, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, Prague, 100 34, Czechia

Location

Axon Clinical s.r.o.

Prague, Prague, 150 00, Czechia

Location

Szpital Swietego Lukasza S. A.

Bielsko-Biala, 43-309, Poland

Location

Specjalistyczny Osrodek Okulistyczny Oculomedica

Bydgoszcz, 00-189, Poland

Location

Prywatna Klinika Okulistyczna OFTALMIKA

Bydgoszcz, 85-631, Poland

Location

Clinical Medical Research Sp. z o.o.

Katowice, 40-156, Poland

Location

Specjalistyczna Praktyka Lekarska Prof. Edward Wylęgała

Katowice, 40-594, Poland

Location

Centrum Medyczne Dietla 19

Krakow, 31-070, Poland

Location

Centrum Diagnostyki i Mikrochirurgii Oka LENS

Olsztyn, 10-424, Poland

Location

Poznanskie Centrum Wzroku sp z o o

Poznan, 60-538, Poland

Location

Centrum Zdrowia MDM

Warsaw, 00-189, Poland

Location

Centrum Medyczne

Wałbrzych, 58304, Poland

Location

Ente Ospedaliero Cantonale

Bellinzona, 6500, Switzerland

Location

Berner Augenklinik

Bern, 3007, Switzerland

Location

Augenarzte Bern Zentrum Marktgasse

Bern, 3011, Switzerland

Location

Vista Augenklinik Binningen

Binningen, 4102, Switzerland

Location

Swiss Visio Montchoisi

Lausanne, 1006, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

The Retina Clinic London

London, Greater London, W1G 7LB, United Kingdom

Location

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, Tyne & Wear, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Clinical Operations Manager

CONTACT

+41815602193; studies@sitala.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); AU (6); PL (10); CZ (3); AR (11); US (20); CH (6)