New pill aims to slow vision loss from dry macular degeneration

NCT ID NCT07606365

Disease control Sponsor: Sitala Bio LTD Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This study tests an oral drug called STL303 for geographic atrophy, a form of dry age-related macular degeneration that causes a blind spot in central vision. About 300 adults aged 60 and older will receive either STL303 or a placebo pill for up to 2 years. The goal is to see if the drug safely slows the loss of cells in the retina and preserves eyesight.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: STL303 (oral drug)
What this could lead to: If it works, this could slow vision loss from geographic atrophy, helping people keep their central eyesight longer.
What could go wrong: This is an early Phase 2 trial with only 300 people. The drug may not slow vision loss or could cause side effects. Success is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration dry age related macular degeneration Geographic Atrophy macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Geographic atrophy

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

56 sites in 7 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

Adelaide Eye and Retina Centre
NOT_YET_RECRUITING

Adelaide, South Australia, 5000, Australia
Augenarzte Bern Zentrum Marktgasse
NOT_YET_RECRUITING

Bern, 3011, Switzerland
Axon Clinical s.r.o.
NOT_YET_RECRUITING

Prague, Prague, 150 00, Czechia
Berner Augenklinik
NOT_YET_RECRUITING

Bern, 3007, Switzerland
Buenos Aires Macula S.A
NOT_YET_RECRUITING

Buenos Aires, Buenos Aires, 1061, Argentina
California Retina Consultants
NOT_YET_RECRUITING

Bakersfield, California, 93309, United States
Centro Medico Viamonte SRL
NOT_YET_RECRUITING

Buenos Aires, Buenos Aires, C1120AAC, Argentina
Centro Oftalmologico Dr. Charles S.A.
NOT_YET_RECRUITING

Buenos Aires, Ciudad Autonoma Buenos Aires, C1121ABB, Argentina
Centro Privado de Ojos
NOT_YET_RECRUITING

Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, C1033AAW, Argentina
Centro de Ojos Quilmes
NOT_YET_RECRUITING

Quilmes, Buenos Aires, 1878, Argentina
Centro de la Vision
NOT_YET_RECRUITING

Salta, Salta Province, 4400, Argentina
Centrovision Mendoza SA
NOT_YET_RECRUITING

Mendoza, Mendoza Province, 5500, Argentina
Centrum Diagnostyki i Mikrochirurgii Oka LENS
NOT_YET_RECRUITING

Olsztyn, 10-424, Poland
Centrum Medyczne
NOT_YET_RECRUITING

Wałbrzych, 58304, Poland
Centrum Medyczne Dietla 19
NOT_YET_RECRUITING

Krakow, 31-070, Poland
Centrum Zdrowia MDM
NOT_YET_RECRUITING

Warsaw, 00-189, Poland
Cerulea Pty Ltd
RECRUITING

East Melbourne, Victoria, 3002, Australia
Clinical Medical Research Sp. z o.o.
NOT_YET_RECRUITING

Katowice, 40-156, Poland
Cumberland Valley Retina Consultants,P.C.
NOT_YET_RECRUITING

Hagerstown, Maryland, 21740, United States
Ente Ospedaliero Cantonale
NOT_YET_RECRUITING

Bellinzona, 6500, Switzerland
Erie Retina Research
RECRUITING

Erie, Pennsylvania, 16507, United States
Eye Clinic of Wisconsin
NOT_YET_RECRUITING

Wausau, Wisconsin, 54403, United States
Fakultni nemocnice Kralovske Vinohrady
NOT_YET_RECRUITING

Prague, Prague, 100 34, Czechia
Grupo Laser Visión - Rosario Eximer Laser Visión
NOT_YET_RECRUITING

Rosario, Santa Fe Province, 2000, Argentina
Hospital Britanico de Buenos Aires
NOT_YET_RECRUITING

Buenos Aires, Ciudad Autonoma Buenos Aires, 1008, Argentina
IMOC Instituto de Microcirugia Ocular Cordoba
NOT_YET_RECRUITING

Córdoba, Córdoba Province, X5000, Argentina
Instituoto Oftalmologico de Buenos Aires S.A.
NOT_YET_RECRUITING

Buenos Aires, Ciudad Autonoma Buenos Aires, C1056, Argentina
Long Island and Queens Vitreoretinal Consultants of NY, P.C.
NOT_YET_RECRUITING

Hauppauge, New York, 11788, United States
Mid Atlantic Retina Specialists
NOT_YET_RECRUITING

Hagerstown, Maryland, 21740, United States
Northeast Wisconsin Retina Associates
NOT_YET_RECRUITING

Appleton, Wisconsin, 54914, United States
OFTEX, s.r.o.
NOT_YET_RECRUITING

Pardubice, Prague, 530 02, Czechia
Ophthalmic Consultants of Boston
NOT_YET_RECRUITING

Waltham, Massachusetts, 02451, United States
Poznanskie Centrum Wzroku sp z o o
NOT_YET_RECRUITING

Poznan, 60-538, Poland
Prywatna Klinika Okulistyczna OFTALMIKA
NOT_YET_RECRUITING

Bydgoszcz, 85-631, Poland
Queensland Eye Institute
NOT_YET_RECRUITING

South Brisbane, Queensland, 4101, Australia
Retina Consultants of Texas
NOT_YET_RECRUITING

Bellaire, Texas, 77401, United States
Retina Consultants of Texas
NOT_YET_RECRUITING

Schertz, Texas, 78154, United States
Retina Group of New England, PC
NOT_YET_RECRUITING

Waterford, Connecticut, 06385, United States
Retina Specialists of Colorado
NOT_YET_RECRUITING

Aurora, Colorado, 80012, United States
Retina-Vitreous Associates Medical Group
NOT_YET_RECRUITING

Beverly Hills, California, 90211, United States
Royal Melbourne Hospital
NOT_YET_RECRUITING

Parkville, Victoria, 3050, Australia
Royal Victoria Infirmary
NOT_YET_RECRUITING

Newcastle upon Tyne, Tyne & Wear, NE1 4LP, United Kingdom
Southampton General Hospital
NOT_YET_RECRUITING

Southampton, Hampshire, SO16 6YD, United Kingdom
Specjalistyczna Praktyka Lekarska Prof. Edward Wylęgała
NOT_YET_RECRUITING

Katowice, 40-594, Poland
Specjalistyczny Osrodek Okulistyczny Oculomedica
NOT_YET_RECRUITING

Bydgoszcz, 00-189, Poland
Stadtspital Triemli
NOT_YET_RECRUITING

Zurich, 8063, Switzerland
Star Vision Research
RECRUITING

Burleson, Texas, 76028, United States
Swiss Visio Montchoisi
NOT_YET_RECRUITING

Lausanne, 1006, Switzerland
Sydney Eye Hospital
NOT_YET_RECRUITING

Sydney, New South Wales, 2000, Australia
Sydney West Retina
NOT_YET_RECRUITING

Westmead, New South Wales, 2145, Australia
Szpital Swietego Lukasza S. A.
NOT_YET_RECRUITING

Bielsko-Biala, 43-309, Poland
Tennessee Retina, PC
NOT_YET_RECRUITING

Nashville, Tennessee, 37203, United States
The Retina Clinic London
NOT_YET_RECRUITING

London, Greater London, W1G 7LB, United Kingdom
University Hospitals of Leicester NHS Trust
NOT_YET_RECRUITING

Leicester, Leicestershire, LE5 4PW, United Kingdom
University Retina and Macula Associates, P.C.
NOT_YET_RECRUITING

Lemont, Illinois, 60439, United States
Vista Augenklinik Binningen
NOT_YET_RECRUITING

Binningen, 4102, Switzerland

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