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A Study in Adults With Geographic Atrophy

24. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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

Typ studie

Intervenční

Zápis (Odhadovaný)

300

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Clinical Operations Manager
  • Telefonní číslo: +41815602193
  • E-mail: studies@sitala.com

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo
Účastníci dostanou placebo
Lék: Placebo
Účastníci ve skupině s placebem obdrží placebo
Experimentální: STL303 dose level 1
Participants will receive STL303 dose level 1
Lék: STL303
STL303 arm participants will receive a specific dose of STL303
Experimentální: STL303 dose level 2
Participants will receive STL303 dose level 2
Lék: STL303
STL303 arm participants will receive a specific dose of STL303

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Reduction of rate of total EZ area loss
Časové okno: From baseline to Week 52
Rate of change in the area of photoreceptor loss
From baseline to Week 52

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of reported treatment-emergent adverse events (TEAE) and serious adverse events (SAEs)
Časové okno: Baseline to week 108
Assess safety and tolerability of STL303
Baseline to week 108
Change in Retinal sensitivity
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Sitala Bio LTD

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. července 2028

Dokončení studie (Odhadovaný)

1. srpna 2029

Termíny zápisu do studia

První předloženo

12. května 2026

První předloženo, které splnilo kritéria kontroly kvality

18. května 2026

První zveřejněno (Aktuální)

26. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • STL303-202

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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