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A Study in Adults With Geographic Atrophy

RecruitingPhase 2Ages 60 Years - anyAllSitala Bio LTD
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 r
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What it tests

  • STL303
  • Placebo
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Where

56 sites
California Retina Consultants
Bakersfield, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, United States
Retina Specialists of Colorado
Aurora, United States
Retina Group of New England, PC
Waterford, United States
University Retina and Macula Associates, P.C.
Lemont, United States
Cumberland Valley Retina Consultants,P.C.
Hagerstown, United States
Mid Atlantic Retina Specialists
Hagerstown, United States
Ophthalmic Consultants of Boston
Waltham, United States

…and 48 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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