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A Study in Adults With Geographic Atrophy

24 mai 2026 mis à jour par: Sitala Bio LTD

A Phase 2, Multicentre, Randomised, Double-masked, Placebo-controlled, Parallel-group, Dose-range Finding Study, to Assess the Efficacy and Safety of Oral STL303 in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Estimé)

300

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Clinical Operations Manager
  • Numéro de téléphone: +41815602193
  • E-mail: studies@sitala.com

Lieux d'étude

  • Argentine
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentine, 1061
        • Buenos Aires Macula S.A
      • Buenos Aires, Buenos Aires, Argentine, C1120AAC
        • Centro Medico Viamonte SRL
      • Quilmes, Buenos Aires, Argentine, 1878
        • Centro de Ojos Quilmes
    • Ciudad Autonoma Buenos Aires
      • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentine, 1008
        • Hospital Británico de Buenos Aires
      • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentine, C1056
        • Instituoto Oftalmologico de Buenos Aires S.A.
      • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentine, C1121ABB
        • Centro Oftalmologico Dr. Charles S.A.
      • Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, Argentine, C1033AAW
        • Centro Privado de Ojos
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentine, X5000
        • IMOC Instituto de Microcirugia Ocular Cordoba
    • Mendoza Province
      • Mendoza, Mendoza Province, Argentine, 5500
        • Centrovision Mendoza SA
    • Salta Province
      • Salta, Salta Province, Argentine, 4400
        • Centro de la Visión
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentine, 2000
        • Grupo Laser Visión - Rosario Eximer Laser Visión
  • Australie
    • New South Wales
      • Sydney, New South Wales, Australie, 2000
        • Sydney Eye Hospital
      • Westmead, New South Wales, Australie, 2145
        • Sydney West Retina
    • Queensland
      • South Brisbane, Queensland, Australie, 4101
        • Queensland Eye Institute
    • South Australia
      • Adelaide, South Australia, Australie, 5000
        • Adelaide Eye and Retina Centre
    • Victoria
      • East Melbourne, Victoria, Australie, 3002
        • Cerulea Pty Ltd
      • Parkville, Victoria, Australie, 3050
        • Royal Melbourne Hospital
  • Pologne
      • Bielsko-Biala, Pologne, 43-309
        • Szpital Swietego Lukasza S. A.
      • Bydgoszcz, Pologne, 85-631
        • Prywatna Klinika Okulistyczna OFTALMIKA
      • Bydgoszcz, Pologne, 00-189
        • Specjalistyczny Osrodek Okulistyczny Oculomedica
      • Katowice, Pologne, 40-156
        • Clinical Medical Research Sp. z o.o.
      • Katowice, Pologne, 40-594
        • Specjalistyczna Praktyka Lekarska Prof. Edward Wylęgała
      • Krakow, Pologne, 31-070
        • Centrum Medyczne Dietla 19
      • Olsztyn, Pologne, 10-424
        • Centrum Diagnostyki i Mikrochirurgii Oka LENS
      • Poznan, Pologne, 60-538
        • Poznanskie Centrum Wzroku sp z o o
      • Warsaw, Pologne, 00-189
        • Centrum Zdrowia MDM
      • Wałbrzych, Pologne, 58304
        • Centrum Medyczne
  • Royaume-Uni
    • Greater London
      • London, Greater London, Royaume-Uni, W1G 7LB
        • The Retina Clinic London
    • Hampshire
      • Southampton, Hampshire, Royaume-Uni, SO16 6YD
        • Southampton General Hospital
    • Leicestershire
      • Leicester, Leicestershire, Royaume-Uni, LE5 4PW
        • University Hospitals of Leicester NHS Trust
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, Royaume-Uni, NE1 4LP
        • Royal Victoria Infirmary
  • Suisse
      • Bellinzona, Suisse, 6500
        • Ente Ospedaliero Cantonale
      • Bern, Suisse, 3007
        • Berner Augenklinik
      • Bern, Suisse, 3011
        • Augenarzte Bern Zentrum Marktgasse
      • Binningen, Suisse, 4102
        • Vista Augenklinik Binningen
      • Lausanne, Suisse, 1006
        • Swiss Visio Montchoisi
      • Zurich, Suisse, 8063
        • Stadtspital Triemli
  • Tchéquie
    • Prague
      • Pardubice, Prague, Tchéquie, 530 02
        • OFTEX, s.r.o.
      • Prague, Prague, Tchéquie, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Prague, Tchéquie, 150 00
        • AXON Clinical s.r.o.
  • États-Unis
    • California
      • Bakersfield, California, États-Unis, 93309
        • California Retina Consultants
        • Chercheur principal:
          • Dilsher Dhoot
      • Beverly Hills, California, États-Unis, 90211
        • Retina-Vitreous Associates Medical Group
        • Chercheur principal:
          • Homayoun Tabandeh
      • Oakland, California, États-Unis, 94612
        • Kaiser Permanente - Oakland
        • Chercheur principal:
          • Robin Vora
    • Colorado
      • Aurora, Colorado, États-Unis, 80012
        • Retina Specialists of Colorado
        • Chercheur principal:
          • Michael Jansen
    • Connecticut
      • Waterford, Connecticut, États-Unis, 06385
        • Retina Group of New England, PC
        • Chercheur principal:
          • Nauman Chaudhry
    • Florida
      • St. Petersburg, Florida, États-Unis, 33711
        • Retina Vitreous Associates of Florida
      • Wildwood, Florida, États-Unis, 34785
        • Florida Retina Institute
        • Chercheur principal:
          • Luis Leon Alvarado
    • Illinois
      • Lemont, Illinois, États-Unis, 60439
        • University Retina and Macula Associates, P.C.
    • Indiana
      • Carmel, Indiana, États-Unis, 46032
        • Associated Vitreoretinal and Uveitis Consultants
        • Chercheur principal:
          • Ramana Moorthy
    • Maryland
      • Hagerstown, Maryland, États-Unis, 21740
        • Mid Atlantic Retina Specialists
        • Chercheur principal:
          • Adam Gerstenblith
      • Hagerstown, Maryland, États-Unis, 21740
        • Cumberland Valley Retina Consultants,P.C.
        • Chercheur principal:
          • Allen Hu
    • Massachusetts
      • Waltham, Massachusetts, États-Unis, 02451
        • Ophthalmic Consultants of Boston
        • Chercheur principal:
          • Chirag Shah
    • New York
      • Hauppauge, New York, États-Unis, 11788
        • Long Island and Queens Vitreoretinal Consultants of NY, P.C.
        • Chercheur principal:
          • Brett Rosenblatt
    • Pennsylvania
      • Erie, Pennsylvania, États-Unis, 16507
        • Erie Retina Research
        • Chercheur principal:
          • David Almeida
    • Tennessee
      • Nashville, Tennessee, États-Unis, 37203
        • Tennessee Retina, PC
        • Chercheur principal:
          • Carl Awh
    • Texas
      • Bellaire, Texas, États-Unis, 77401
        • Retina Consultants of Texas
        • Chercheur principal:
          • David Brown
      • Burleson, Texas, États-Unis, 76028
        • Star Vision Research
        • Chercheur principal:
          • Courtney Crawford
      • Schertz, Texas, États-Unis, 78154
        • Retina Consultants of Texas
        • Chercheur principal:
          • Jeremiah Brown
    • Wisconsin
      • Appleton, Wisconsin, États-Unis, 54914
        • Northeast Wisconsin Retina Associates
        • Chercheur principal:
          • Swati Agarwal Sinha
      • Wausau, Wisconsin, États-Unis, 54403
        • Eye Clinic of Wisconsin
        • Chercheur principal:
          • Deepak Sambhara

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo
Les participants recevront un placebo
Médicament: Placebo
Les participants du bras placebo recevront un placebo
Expérimental: STL303 dose level 1
Participants will receive STL303 dose level 1
Médicament: STL303
STL303 arm participants will receive a specific dose of STL303
Expérimental: STL303 dose level 2
Participants will receive STL303 dose level 2
Médicament: STL303
STL303 arm participants will receive a specific dose of STL303

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Reduction of rate of total EZ area loss
Délai: From baseline to Week 52
Rate of change in the area of photoreceptor loss
From baseline to Week 52

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of reported treatment-emergent adverse events (TEAE) and serious adverse events (SAEs)
Délai: Baseline to week 108
Assess safety and tolerability of STL303
Baseline to week 108
Change in Retinal sensitivity
Délai: From enrolment to end of treatment at week 104
Mesopic microperimetry using participant-customised peri-lesional grid.
From enrolment to end of treatment at week 104
Rate of disease progression (photoreceptor loss)
Délai: From enrolment to end of treatment at week 104
Rate of change in the area of photoreceptor loss (defined as ellipsoid zone to retinal pigment epithelium thickness of 0 μm) in the study eye, as assessed by spectral-domain optical coherence tomography (SD-OCT)
From enrolment to end of treatment at week 104
Maximum serum concertation at steady-state (Cmax, ss) of STL303
Délai: Weeks 0, 4, 12, 26, 52, 78, and 104 pre and 2 hours post dose.
Measure maximum plasma concentration at steady-state (Cmax, ss) at steady state.
Weeks 0, 4, 12, 26, 52, 78, and 104 pre and 2 hours post dose.
Determine pharmacodynamic profile of STL 303
Délai: Weeks 0, 4, 12, 26, 52, 78 and 104 pre and 2 hours post dose.
Change from baseline in complement alternative pathway (AP) functional activity as measured by the Wieslab assay in serum
Weeks 0, 4, 12, 26, 52, 78 and 104 pre and 2 hours post dose.
Trough plasma concentration at steady-state of STL303
Délai: Weeks 0, 4, 12, 26, 52, 78, and 104 pre and 2 hours post dose.
Measure trough plasma concentration at steady-state (Cmin, ss /Ctrough, ss),
Weeks 0, 4, 12, 26, 52, 78, and 104 pre and 2 hours post dose.
Area under plasma concentration-time curve for STL303
Délai: Weeks 0, 4, 12, 26, 52, 78, and 104 pre and 2 hours post dose.
Measure the area under the plasma concentration-time curve over one dosing interval at steady state (AUCtau)
Weeks 0, 4, 12, 26, 52, 78, and 104 pre and 2 hours post dose.
Change in Vision-Related Quality of Life
Délai: From Baseline to end of treatment at week 104
Change from baseline in the National Eye Institute 25 item Visual Functioning Questionnaire (NEI VFQ-25). Range: 0-100, where higher scores indicate better vision-related quality of life.
From Baseline to end of treatment at week 104

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sitala Bio LTD

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juillet 2028

Achèvement de l'étude (Estimé)

1 août 2029

Dates d'inscription aux études

Première soumission

12 mai 2026

Première soumission répondant aux critères de contrôle qualité

18 mai 2026

Première publication (Réel)

26 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STL303-202

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data (IPD) will not be shared because participant consent and ethics approvals do not permit public data sharing. A clinical study report will be prepared at the end of the study and result will be shared with research sites and investigators will be able to discuss results with participants if needed.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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