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A Study in Adults With Geographic Atrophy

2026年5月24日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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

研究の種類

介入

入学 (推定)

300

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Clinical Operations Manager
  • 電話番号：+41815602193
  • メール：studies@sitala.com

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：プラセボ
参加者はプラセボを受け取ります
薬：プラセボ
プラセボ群の参加者はプラセボを受け取ります
実験的：STL303 dose level 1
Participants will receive STL303 dose level 1
薬：STL303
STL303 arm participants will receive a specific dose of STL303
実験的：STL303 dose level 2
Participants will receive STL303 dose level 2
薬：STL303
STL303 arm participants will receive a specific dose of STL303

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Reduction of rate of total EZ area loss
時間枠：From baseline to Week 52
Rate of change in the area of photoreceptor loss
From baseline to Week 52

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of reported treatment-emergent adverse events (TEAE) and serious adverse events (SAEs)
時間枠：Baseline to week 108
Assess safety and tolerability of STL303
Baseline to week 108
Change in Retinal sensitivity
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Sitala Bio LTD

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2028年7月1日

研究の完了 (推定)

2029年8月1日

試験登録日

最初に提出

2026年5月12日

QC基準を満たした最初の提出物

2026年5月18日

最初の投稿 (実際)

2026年5月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月28日

QC基準を満たした最後の更新が送信されました

2026年5月24日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • STL303-202

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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