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NCT07606365PHASE2Recruiting

A Study in Adults With Geographic Atrophy

Sitala Bio LTD

Start Date

9/11/2026

Completion Date

8/1/2029

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.

Detailed Description

This study is designed as a randomized, multi-center, double-masked, dose-range finding study to characterize the efficacy and safety of STL303.

Eligibility Criteria

Age Range: 60 years to No maximum

Inclusion Criteria: The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with the better visual acuity at the Screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be selected as the study eye. 1. Participants ≥60 years of age at the time of Screening (signing the ICF). 2. Diagnosis of non-exudative AMD in both eyes, with confirmed presence of phenotypic hallmarks of AMD such as hard and/or soft drusen. 3. The GA lesion in the study eye must meet the following criteria as determined by the central Reading Centre's assessment at Screening: 1. Total GA area must be ≥2.5 and ≤10.16 mm2 (1 and 4 DA, respectively) as measured using SD-OCT. 2. 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. 3. 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. 4. 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). 5. All GA lesions must be at least 150 μm from foveal centre. 4. Confirmed presence of any pattern of hyper-autofluorescence in the junctional zone of GA; absence of hyper-autofluorescence is exclusionary. 5. 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. 6. Low luminance visual acuity (LLVA) by ETDRS score of ≥10 letters in the study eye at the Screening visit and Baseline visit. 7. Meets the following criteria related to microperimetry: 1. Able to detect fixation target. 2. Fixation losses must be ≤20%. 3. Participant is willing and able to undertake microperimetry assessment in the opinion of the Investigator. 8. Able to take IMP or have an appropriate designee who can administer the IMP (i.e., a capable family member or caregiver). 9. Able to provide written informed consent and willing to comply with all site visits, examinations, daily IMP administrations and dosing diary entries, and other conditions of the study protocol. 10. Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator. 11. The fellow eye may have any of the following: AMD without GA, AMD with GA, or foveal GA (ongoing treatment with complement inhibitor therapies in the fellow eye is allowed). 12. Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection are required at least two weeks prior to the start of the treatment with STL303. 13. If not received previously, vaccination against Haemophilus influenzae type b infection should be given, if available and according to local regulations. 14. Body mass index (BMI) ≥18 kg/m2 to ≤40 kg/m2. 15. Participants of childbearing potential (POCBP) must use an appropriate birth control if not confirmed postmenopausal; male participants with partners of childbearing potential must agree to use highly effective contraception methods during the study and for 1 month after the last dose of the IMP. 16. Participants must agree to refrain from donating gametes during the duration of the study and for 1 month after the last dose of the IMP. Exclusion Criteria: 1. 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. 2. 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). 3. Previous treatment with any ocular photodynamic therapy or laser coagulation to the macula in the study eye. 4. Presence of active/current retinal vein occlusion in the study eye. 5. Presence of vitreous haemorrhage in the study eye. 6. History of retinal detachment in the study eye. 7. Ocular conditions - either eye: 1. Presence of at least moderate non-proliferative diabetic retinopathy (or worse) in either eye (a history of diabetes mellitus without retinopathy and mild non-proliferative diabetic retinopathy is not a criterion for exclusion). 2. 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. 3. History of herpetic infection in either eye. 4. Active uveitis and/or vitritis (grade trace or above) in either eye. 5. History of idiopathic or autoimmune-associated uveitis in either eye. 6. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye. 7. Spherical equivalent of the refractive error demonstrating \>6 diopters of myopia or an axial length \>26 mm in either eye. 8. Intraocular surgery (including lens replacement surgery) within 3 months prior to randomisation in either eye. 9. Yttrium Aluminium Garnet (YAG) laser in either eye within 1 month prior to randomisation. 8. History of infection with Neisseria meningitidis, Streptococcus pneumoniae or Haemophilus influenzae type b despite vaccination. 9. History or known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)-positivity (unless treated \[for HBV and HCV only\]) and achieved sustained viral response with negative polymerase chain reaction (PCR). 10. Known ongoing immunodeficiency with or without treatment. 11. Previous participation in a retinal gene therapy clinical study where the gene therapy was delivered to either eye. 12. History of any prior IVT treatment for any indication other than AMD in either eye. Prior IVT treatment for CNV is permitted in the fellow eye so long as the last injection was more than two years previously. 13. Any prior treatment for AMD in the study eye (for example, surgical, radiation, thermotherapeutic, or laser intervention), except oral supplements or minerals; prior treatment with Izervay or Syfovre is allowed in the study eye so long as 6 months have elapsed since the last treatment and so long as the participant did not experience any ocular inflammation or adverse events during the treatment with either Izervay or Syfovre. Ongoing treatment with Izervay or Syfovre is permitted in the fellow eye. 14. Usage of systemic immunosuppressants or other immunomodulatory drugs within 90 days prior to the first administration or within 5 half-lives of the drug (whichever is longer), specifically including but not limited to cyclophosphamide, rituximab, infliximab, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, systemic corticosteroids (inhaled or topical corticosteroids, or corticosteroids directly injected into the joints are allowed). 15. Previous treatment with other systemic complement inhibitors within 30 days prior to the first dose, or within 5 half-lives of the drug, or within the potential period of residual effects from previous clinical studies, such as anti-sense oligonucleotide (ASO) or ribonucleic acid interference (RNAi), whichever is longer. 16. Participants with any unstable or clinically significant medical condition that, in the opinion of the Investigator, could pose a risk of complications or interfere with participation during the course of the study. 17. Participants with prolonged corrected QT interval (QTc) at Screening or at Baseline (QT interval corrected using Fridericia's formula \[QTcF\] \>480 ms). 18. Participants with clinically-relevant cardiac events within the last 2 years. 19. Participants with significantly abnormal liver function at Screening or at Baseline: any parameter of ALT, AST, gamma glutamyl transferase (GGT) or alkaline phosphatase (ALP) \>3 × upper limit of normal (ULN); serum bilirubin total \>1.5 × ULN. 20. Platelet count \<75000 cells/mm3. 21. Haemoglobin value \<8 gm/dL. 22. History of end stage liver or kidney disease requiring dialysis or transplant. 23. History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes or clinically relevant sensitivity to fluorescein dye as assessed by the Investigator. 24. History of alcohol or drug abuse within the last 5 years. 25. Ongoing treatment with cytochrome P450 2C8 (CYP2C8) inhibitors, or inducers or strong P-glycoprotein inhibitors. 26. Ongoing participation in any other clinical study.

Interventions

DRUG

STL303

DRUG

Placebo

Interested in This Trial?

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Conditions

Geographic Atrophy

Locations

California Retina Consultants

Bakersfield, California 93309

United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California 90211

United States

Retina Specialists of Colorado

Aurora, Colorado 80012

United States

Retina Group of New England, PC

Waterford, Connecticut 06385

United States

University Retina and Macula Associates, P.C.

Lemont, Illinois 60439

United States

Cumberland Valley Retina Consultants,P.C.

Hagerstown, Maryland 21740

United States

Mid Atlantic Retina Specialists

Hagerstown, Maryland 21740

United States

Ophthalmic Consultants of Boston

Waltham, Massachusetts 02451

United States

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

Hauppauge, New York 11788

United States

Erie Retina Research

Erie, Pennsylvania 16507

United States

Tennessee Retina, PC

Nashville, Tennessee 37203

United States

Retina Consultants of Texas

Bellaire, Texas 77401

United States

Star Vision Research

Burleson, Texas 76028

United States

Retina Consultants of Texas

Schertz, Texas 78154

United States

Northeast Wisconsin Retina Associates

Appleton, Wisconsin 54914

United States

Eye Clinic of Wisconsin

Wausau, Wisconsin 54403

United States

Buenos Aires Macula S.A

Buenos Aires, Buenos Aires 1061

Argentina

Centro Medico Viamonte SRL

Buenos Aires, Buenos Aires C1120AAC

Argentina

Centro de Ojos Quilmes

Quilmes, Buenos Aires 1878

Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Ciudad Autonoma Buenos Aires 1008

Argentina

Instituoto Oftalmologico de Buenos Aires S.A.

Buenos Aires, Ciudad Autonoma Buenos Aires C1056

Argentina

Centro Oftalmologico Dr. Charles S.A.

Buenos Aires, Ciudad Autonoma Buenos Aires C1121ABB

Argentina

Centro Privado de Ojos

Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires C1033AAW

Argentina

IMOC Instituto de Microcirugia Ocular Cordoba

Córdoba, Córdoba Province X5000

Argentina

Centrovision Mendoza SA

Mendoza, Mendoza Province 5500

Argentina

Centro de la Vision

Salta, Salta Province 4400

Argentina

Grupo Laser Visión - Rosario Eximer Laser Visión

Rosario, Santa Fe Province 2000

Argentina

Sydney Eye Hospital

Sydney, New South Wales 2000

Australia

Sydney West Retina

Westmead, New South Wales 2145

Australia

Queensland Eye Institute

South Brisbane, Queensland 4101

Australia

Adelaide Eye and Retina Centre

Adelaide, South Australia 5000

Australia

Cerulea Pty Ltd

East Melbourne, Victoria 3002

Australia

Royal Melbourne Hospital

Parkville, Victoria 3050

Australia

OFTEX, s.r.o.

Pardubice, Prague 530 02

Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Prague 100 34

Czechia

Axon Clinical s.r.o.

Prague, Prague 150 00

Czechia

Szpital Swietego Lukasza S. A.

Bielsko-Biala, 43-309

Poland

Specjalistyczny Osrodek Okulistyczny Oculomedica

Bydgoszcz, 00-189

Poland

Prywatna Klinika Okulistyczna OFTALMIKA

Bydgoszcz, 85-631

Poland

Clinical Medical Research Sp. z o.o.

Katowice, 40-156

Poland

Specjalistyczna Praktyka Lekarska Prof. Edward Wylęgała

Katowice, 40-594

Poland

Centrum Medyczne Dietla 19

Krakow, 31-070

Poland

Centrum Diagnostyki i Mikrochirurgii Oka LENS

Olsztyn, 10-424

Poland

Poznanskie Centrum Wzroku sp z o o

Poznan, 60-538

Poland

Centrum Zdrowia MDM

Warsaw, 00-189

Poland

Centrum Medyczne

Wałbrzych, 58304

Poland

Ente Ospedaliero Cantonale

Bellinzona, 6500

Switzerland

Berner Augenklinik

Bern, 3007

Switzerland

Augenarzte Bern Zentrum Marktgasse

Bern, 3011

Switzerland

Vista Augenklinik Binningen

Binningen, 4102

Switzerland

Swiss Visio Montchoisi

Lausanne, 1006

Switzerland

Stadtspital Triemli

Zurich, 8063

Switzerland

The Retina Clinic London

London, Greater London W1G 7LB

United Kingdom

Southampton General Hospital

Southampton, Hampshire SO16 6YD

United Kingdom

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire LE5 4PW

United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, Tyne & Wear NE1 4LP

United Kingdom