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Clinical Trials in the USA / NCT07606365
Starting soon Phase 2

A Study in Adults With Geographic Atrophy

NCT07606365 · tracked via the Priya Life Science USA tracker
Sponsor
Sitala Bio LTD
Phase
Phase 2
Started
2026-06
Last updated
2026-05-28

Condition(s) studied

Geographic Atrophy

Investigational drug(s) / intervention(s)

STL303Placebo

STL303: STL303 arm participants will receive a specific dose of STL303

Placebo: Placebo arm participants will receive placebo

Study 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (60)

FacilityCityRegionStatus
California Retina Consultants Bakersfield California
Retina-Vitreous Associates Medical Group Beverly Hills California
Kaiser Permanente - Oakland Oakland California
Retina Specialists of Colorado Aurora Colorado
Retina Group of New England, PC Waterford Connecticut
Retina Vitreous Associates of Florida St. Petersburg Florida
Florida Retina Institute Wildwood Florida
University Retina and Macula Associates, P.C. Lemont Illinois
Associated Vitreoretinal and Uveitis Consultants Carmel Indiana
Cumberland Valley Retina Consultants,P.C. Hagerstown Maryland
Mid Atlantic Retina Specialists Hagerstown Maryland
Ophthalmic Consultants of Boston Waltham Massachusetts
Long Island and Queens Vitreoretinal Consultants of NY, P.C. Hauppauge New York
Erie Retina Research Erie Pennsylvania
Tennessee Retina, PC Nashville Tennessee
Retina Consultants of Texas Bellaire Texas
Star Vision Research Burleson Texas
Retina Consultants of Texas Schertz Texas
Northeast Wisconsin Retina Associates Appleton Wisconsin
Eye Clinic of Wisconsin Wausau Wisconsin
Buenos Aires Macula S.A Buenos Aires Buenos Aires
Centro Medico Viamonte SRL Buenos Aires Buenos Aires
Centro de Ojos Quilmes Quilmes Buenos Aires
Hospital Britanico de Buenos Aires Buenos Aires Ciudad Autonoma Buenos Aires
Instituoto Oftalmologico de Buenos Aires S.A. Buenos Aires Ciudad Autonoma Buenos Aires
Centro Oftalmologico Dr. Charles S.A. Buenos Aires Ciudad Autonoma Buenos Aires
Centro Privado de Ojos Ciudad Autonoma Buenos Aires Ciudad Autonoma Buenos Aires
IMOC Instituto de Microcirugia Ocular Cordoba Córdoba Córdoba Province
Centrovision Mendoza SA Mendoza Mendoza Province
Centro de la Vision Salta Salta Province
Grupo Laser Visión - Rosario Eximer Laser Visión Rosario Santa Fe Province
Sydney Eye Hospital Sydney New South Wales
Sydney West Retina Westmead New South Wales
Queensland Eye Institute South Brisbane Queensland
Adelaide Eye and Retina Centre Adelaide South Australia
Cerulea Pty Ltd East Melbourne Victoria
Royal Melbourne Hospital Parkville Victoria
OFTEX, s.r.o. Pardubice Prague
Fakultni nemocnice Kralovske Vinohrady Prague Prague
Axon Clinical s.r.o. Prague Prague

+ 20 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07606365 on ClinicalTrials.gov ↗ ← All trials in the USA