이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

A Study in Adults With Geographic Atrophy

2026년 5월 24일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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

연구 유형

중재적

등록 (추정된)

300

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Clinical Operations Manager
  • 전화번호: +41815602193
  • 이메일: studies@sitala.com

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
참가자는 위약을 받게됩니다
의약품: 플라시보
위약군 참가자는 위약을 투여받게 됩니다
실험적: STL303 dose level 1
Participants will receive STL303 dose level 1
의약품: STL303
STL303 arm participants will receive a specific dose of STL303
실험적: STL303 dose level 2
Participants will receive STL303 dose level 2
의약품: STL303
STL303 arm participants will receive a specific dose of STL303

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Reduction of rate of total EZ area loss
기간: From baseline to Week 52
Rate of change in the area of photoreceptor loss
From baseline to Week 52

2차 결과 측정

결과 측정
측정값 설명
기간
Number of reported treatment-emergent adverse events (TEAE) and serious adverse events (SAEs)
기간: Baseline to week 108
Assess safety and tolerability of STL303
Baseline to week 108
Change in Retinal sensitivity
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sitala Bio LTD

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2028년 7월 1일

연구 완료 (추정된)

2029년 8월 1일

연구 등록 날짜

최초 제출

2026년 5월 12일

QC 기준을 충족하는 최초 제출

2026년 5월 18일

처음 게시됨 (실제)

2026년 5월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 24일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • STL303-202

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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