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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema (NAAVIGATE)

2026年9月8日 更新者：AbbVie

An Operationally Seamless Phase 2b/3, Multicenter, Randomized, Masked, Sham-controlled Study to Evaluate the Efficacy and Safety of Surabgene Lomparvovec (Sura-vec) Delivered Via Suprachoroidal Space (SCS) Injection Targeting Subjects With Diabetic Retinopathy Without Center Involved-Diabetic Macular Edema (CI-DME) (NAAVIGATE)

Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina). Over time, this damage can lead to vision problems and even blindness if not treated. This study will assess surabgene lomparvovec (sura-vec) as a potential one-time gene therapy administered in the suprachoroidal space (SCS) for the treatment of diabetic retinopathy (DR) and prevention of vision-threatening events (VTEs) in participants with non-proliferative DR (NPDR) without center-involved diabetic macular edema (CI-DME).

This study will consist of 3 portions: a Phase 2b portion, a Phase 3 portion, and a bilateral treatment portion. Approximately 576 adult participants will be enrolled in the study across multiple sites in the United States and Puerto Rico.

In the Phase 2b and Phase 3 portions, participants will be randomized to different groups to receive sura-vec and prophylactic steroids or sham and artificial tears in their study eye. If assigned to sham, participants will be given an opportunity to cross over and receive treatment with sura-vec. In the bilateral treatment portion, participants will be enrolled to receive sura-vec and prophylactic steroids in both eyes. In all 3 portions, follow-up in the study will continue through 5 years following administration of sura-vec in each eye.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

576

段階

  • フェーズ2
  • フェーズ 3

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

研究場所

  • アメリカ
    • Arizona
      • Phoenix、Arizona、アメリカ、85053
        • 募集
        • Retinal Consultants Of Arizona - Phoenix - North /ID# 283407
      • Scottsdale、Arizona、アメリカ、85255-4134
        • 募集
        • Retina Macula Institute of Arizona /ID# 282881
    • California
      • Bakersfield、California、アメリカ、93309
        • 募集
        • California Retina Consultants - Bakersfield /ID# 282990
      • Encino、California、アメリカ、91436
        • 募集
        • The Retina Partners /ID# 274741
      • Mountain View、California、アメリカ、94040-4119
        • 募集
        • Northern California Retina Vitreous Associates /ID# 282994
      • Pasadena、California、アメリカ、91107
        • 募集
        • California Eye Specialists Medical Group /ID# 274705
      • Poway、California、アメリカ、92064
        • 募集
        • Retina Consultants San Diego /ID# 274748
      • San Francisco、California、アメリカ、94109
        • 募集
        • West Coast Retinal Medical Group /ID# 283007
      • Torrance、California、アメリカ、90503
        • 募集
        • Macula Retina Vitreous Center - Torrance /ID# 282878
      • Walnut Creek、California、アメリカ、94598-5910
        • 募集
        • Bay Area Retina Associates /ID# 275032
    • Colorado
      • Durango、Colorado、アメリカ、81303
        • 募集
        • Southwest Retina Research Center /ID# 276094
      • Lakewood、Colorado、アメリカ、80228
        • 募集
        • Colorado Retina Associates /ID# 283006
    • Florida
      • Lakeland、Florida、アメリカ、33805
        • 募集
        • Florida Retina Consultants - Lakeland /ID# 275012
      • Orlando、Florida、アメリカ、32806
        • 募集
        • Florida Retina Institute - Orlando /ID# 283034
      • Pensacola、Florida、アメリカ、32503
        • 募集
        • Retina Speciality Institute /ID# 274996
    • Georgia
      • Augusta、Georgia、アメリカ、30909
        • 募集
        • Southeast Retina Center /ID# 274739
    • Illinois
      • Chicago、Illinois、アメリカ、60657
        • 募集
        • Illinois Retina Associates S.C /ID# 283048
      • Oak Forest、Illinois、アメリカ、60452
        • 募集
        • University Retina - Oak Forest /ID# 283021
      • Springfield、Illinois、アメリカ、62702
        • 募集
        • Springfield Clinic - First /ID# 283028
    • Kansas
      • Lenexa、Kansas、アメリカ、66215
        • 募集
        • Retina Associates - Lenexa /ID# 283004
    • Maine
      • Portland、Maine、アメリカ、04101
        • 募集
        • Maine Eye Center - Marginal Way Campus /ID# 275039
    • Maryland
      • Hagerstown、Maryland、アメリカ、21740
        • 募集
        • Mid Atlantic Retina Specialists - Hagerstown /ID# 274725
    • Nevada
      • Reno、Nevada、アメリカ、89502
        • 募集
        • Sierra Eye Associates /ID# 274737
    • New Jersey
      • Bloomfield、New Jersey、アメリカ、07003
        • 募集
        • Retina Center Of New Jersey /ID# 283088
    • Ohio
      • Beachwood、Ohio、アメリカ、44122
        • 募集
        • Retina Associates Of Cleveland - Beachwood /ID# 275985
    • South Carolina
      • Charleston、South Carolina、アメリカ、29414
        • 募集
        • Charleston Neuroscience Institute - Charleston /ID# 275047
    • Texas
      • Austin、Texas、アメリカ、78705
        • 募集
        • Austin Research Center for Retina /ID# 276101
      • Burleson、Texas、アメリカ、76028
        • 募集
        • Star Retina /ID# 276513
      • Dallas、Texas、アメリカ、75231
        • 募集
        • Texas Retina Associates - Dallas /ID# 276117
    • Virginia
      • Salem、Virginia、アメリカ、24153
        • 募集
        • Vistar Eye Center - Salem /ID# 282879
  • プエルトリコ
      • Arecibo、プエルトリコ、00612
        • 募集
        • Emanuelli Research & Development Center /ID# 275378

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:

Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)

  • Moderately severe or severe nonproliferative diabetic retinopathy (NPDR) (early treatment diabetic retinopathy study-diabetic retinopathy severity scale [DRSS] level 47 or 53) for which panretinal photocoagulation (PRP) or anti- vascular endothelial growth factor (VEGF) can be safely deferred for at least 6 months after Screening Visit 1.
  • Best-corrected visual acuity (BCVA) in the study eye of >= 69 Early treatment diabetic retinopathy study letters (approximate Snellen equivalent 20/40 or better) at Screening Visit 1.

Systemic

• Diabetic retinopathy (DR) secondary to diabetes mellitus Type 1 or 2 with a hemoglobin A1c (HbA1c)< 12% within 60 days prior to Screening Visit 1.

Exclusion Criteria:

Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)

  • Presence of active center involved-diabetic macular edema (CI-DME) in the study eye as determined by spectral domain optical coherence tomography (SD-OCT) evaluated by the central reading center (CRC), using the following threshold:

Central retinal thickness (CRT) >= 320 μm as measured by Heidelberg Spectralis SD-OCT (conversion to equivalent measurement is required and performed by the CRC if imaging is done with another SD-OCT instrument).

  • Active ocular inflammation including scleral inflammation (including episcleritis) or ocular/ periocular infection present in either eye at Screening Visit 1 or Screening Visit 2
  • Neovascularization from a cause other than DR, per investigator
  • Evidence or documented history of panretinal photocoagulation (PRP) or retinal laser therapy
  • History of intravitreal therapy, including anti-VEGF and long- or short-acting steroid therapy, within the prior 6 months and documentation of more than 10 prior anti-VEGF or short acting steroid intravitreal injections within 36 months of Screening Visit 1
  • Pregnant and breastfeeding individuals are excluded from this clinical study.

Systemic

  • Initiation of intensive insulin treatment (pump or multiple daily injections) within the past 6 months or plans to do so within 52 weeks after Day 1
  • Initiation of any treatment containing a GLP-1 receptor agonist within the 3 months prior to Screening Visit 1 or plans to do so within 52 weeks after Day 1
  • Pregnant and breastfeeding individuals are excluded from this 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：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Phase 2b: Surabgene Lomparvovec + Steroid-Regimen A
Participants will receive a single Suprachoroidal space (SCS) injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen A.
薬：Surabgene Lomparvovec
Solution Injection
薬：Topical Steroid
Topical Drops
実験的：Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B
Participants will receive a single SCS injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen B.
薬：Surabgene Lomparvovec
Solution Injection
薬：Topical Steroid
Topical Drops
プラセボコンパレーター：Phase 2b: Sham + Artificial Tears -Regimen A
Participants will receive a single injection of sham+ artificial tears -Regimen A.
薬：Sham
needleless injection without fluid
薬：Artificial Tears
Topical Drops
プラセボコンパレーター：Phase 2b: Sham + Artificial Tears -Regimen B
Participants will receive a single injection of Sham+ artificial tears -Regimen B.
薬：Sham
needleless injection without fluid
薬：Artificial Tears
Topical Drops
実験的：Phase 3: Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid
薬：Surabgene Lomparvovec
Solution Injection
薬：Topical Steroid
Topical Drops
プラセボコンパレーター：Phase 3: Sham + Artificial Tears
Participants will receive a single injection of Sham + artificial tears.
薬：Sham
needleless injection without fluid
薬：Artificial Tears
Topical Drops
実験的：Bilateral: B1-Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid eye drops in each eye.
薬：Surabgene Lomparvovec
Solution Injection
薬：Topical Steroid
Topical Drops
実験的：Bilateral: B2-Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye.
薬：Surabgene Lomparvovec
Solution Injection
薬：Topical Steroid
Topical Drops

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
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 52
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 52
Phase 3: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 52
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 52
Bilateral Portion: Bilateral portion: Number of participants experiencing ocular Adverse Events (AEs), Serious Adverse Events (SAEs), or any Adverse Events of Special Interest (AESIs)
時間枠：Up to Approximately Week 104
Safety of bilateral administration with sura-vec will be assessed with Ocular AEs, SAEs, and AESIs. An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to Approximately Week 104
Bilateral Portion: Participants Who Experience Intraocular Inflammation
時間枠：Up to Approximately Week 104
Percentage of participants who experience intraocular inflammation.
Up to Approximately Week 104
Bilateral Portion: Participants Who Experience Scleral Inflammation Including Episcleritis
時間枠：Up to Approximately Week 104
Percentage of participants who experience scleral inflammation including episcleritis.
Up to Approximately Week 104

二次結果の測定

結果測定
メジャーの説明
時間枠
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
時間枠：Up to Approximately Week 52
Participants will be assessed for the development of VTEs
Up to Approximately Week 52
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
時間枠：Up to Approximately Week 104
Participants will be assessed for the development of VTEs
Up to Approximately Week 104
Phase 2B: Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye
時間枠：Up to Approximately Week 52
Participants will be assessed for the progression to PDR or ASNV.
Up to Approximately Week 52
Phase 2B: Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye
時間枠：Up to Approximately Week 104
Participants will be assessed for the progression to PDR or ASNV.
Up to Approximately Week 104
Phase 2B: Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye
時間枠：Up to Approximately Week 52
Participants will be assessed for the development of CI-DME.
Up to Approximately Week 52
Phase 2B: Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye
時間枠：Up to Approximately Week 104
Participants will be assessed for the development of CI-DME.
Up to Approximately Week 104
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 104
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 104
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.
時間枠：Up to approximately Week 14
Percentage of participants who develop treatment-emergent ocular inflammation.
Up to approximately Week 14
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.
時間枠：Up to approximately Week 24
Percentage of participants who develop treatment-emergent ocular inflammation.
Up to approximately Week 24
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.
時間枠：Up to approximately Week 38
Percentage of participants who develop treatment-emergent ocular inflammation.
Up to approximately Week 38
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.
時間枠：Up to approximately Week 52
Percentage of participants who develop treatment-emergent ocular inflammation.
Up to approximately Week 52
Phase 2B: Percentage of Participants Achieving>= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 52
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 52
Phase 2B: Percentage of Participants Achieving >= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 104
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 104
Phase 2B: Percentage of Participants With No Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 52
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 52
Phase 2B: Percentage of participants With No Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 104
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 104
Phase 2B: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.
時間枠：At Week 52
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 52
Phase 2B: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.
時間枠：At Week 104
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 104
Phase 2B: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 52
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 52
Phase 2B: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 104
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 104
Phase 2B: Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 52
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 52
Phase 2B: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 104
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 104
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis
時間枠：Up to approximately Week 14
Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.
Up to approximately Week 14
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis
時間枠：Up to approximately Week 24
Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.
Up to approximately Week 24
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis
時間枠：Up to approximately Week 38
Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.
Up to approximately Week 38
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis
時間枠：Up to approximately Week 52
Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.
Up to approximately Week 52
Phase 2B: Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye
時間枠：Up to Approximately Week 52
Percentage of participants who receive treatments for DR complications in the study eye.
Up to Approximately Week 52
Phase 2B: Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye
時間枠：Up to Approximately Week 104
Percentage of participants who receive treatments for DR complications in the study eye.
Up to Approximately Week 104
Phase 3 (key secondary): Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
時間枠：Up to Approximately Week 52
Participants will be assessed for the development of VTEs
Up to Approximately Week 52
Phase 3 (key secondary): Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
時間枠：Up to Approximately Week 104
Participants will be assessed for the development of VTEs
Up to Approximately Week 104
Phase 3 (key secondary): Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye
時間枠：Up to Approximately Week 52
Participants will be assessed for the progression to PDR or ASNV.
Up to Approximately Week 52
Phase 3 (key secondary): Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye
時間枠：Up to Approximately Week104
Participants will be assessed for the progression to PDR or ASNV.
Up to Approximately Week104
Phase 3 (key secondary): Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye
時間枠：Up to Approximately Week 52
Participants will be assessed for the development of CI-DME.
Up to Approximately Week 52
Phase 3 (key secondary): Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye
時間枠：Up to Approximately Week 104
Participants will be assessed for the development of CI-DME.
Up to Approximately Week 104
Phase 3 (key secondary):Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 104
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 104
Phase 3: Percentage of Participants Achieving >= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 104
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 104
Phase 3: Percentage of Participants With No change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 52
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 52
Phase 3: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 104
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 104
Phase 3: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.
時間枠：At Week 52
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 52
Phase 3: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.
時間枠：At Week 104
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 104
Phase 3: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 52
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 52
Phase 3: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
時間枠：At Week 104
The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.
At Week 104
Phase 3: Percentage of Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye
時間枠：Up to approximately Week 52
Percentage of participants who receive treatments for DR complications in the study eye.
Up to approximately Week 52
Phase 3: Percentage of Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye
時間枠：Up to approximately Week 104
Percentage of participants who receive treatments for DR complications in the study eye.
Up to approximately Week 104
Bilateral Portion: Percentage of Participants Experiencing Nonocular Adverse Events (AE)s
時間枠：Up to Approximately Week 104
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to Approximately Week 104
Bilateral Portion: Percentage of Participants Experiencing Nonocular Serious Adverse Events (SAE)s
時間枠：Up to Approximately Week 104
An SAE is defined as any AE, whether or not associated with study treatment that meets any of the following criteria: death of a participant, hospitalization or prolonged hospitalization, congenital anomaly, persistent or significant disability/incapacity, and important medical event requiring medical or surgical intervention to prevent serious outcome.
Up to Approximately Week 104
Bilateral Portion: Percentage of Participants With Vector Shedding in Urine
時間枠：Up to Approximately Week 12
Vector shedding in urine is defined as measurement of vector Deoxyribonucleic Acid (DNA) concentrations in urine.
Up to Approximately Week 12
Bilateral Portion: Percentage of Participants With Vector Shedding in Tears
時間枠：Up to Approximately Week 12
Vector shedding in tears is defined as measurement of vector DNA concentrations in tears.
Up to Approximately Week 12
Bilateral Portion: Percentage of Participants With Vector DNA Concentrations in Serum
時間枠：Up to Approximately Week 104
Vector shedding in urine is defined as measurement of vector DNA concentrations in serum.
Up to Approximately Week 104
Bilateral Portion: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) Level
時間枠：Up to Approximately Week 104
Change from baseline in DRSS level is defined as 0-step (no change), a ≥ 1-step, a ≥ 2-step, or a ≥ 3-step change.
Up to Approximately Week 104
Bilateral Portion: Maintenance of Visual Acuity From Baseline
時間枠：Up to Approximately Week 104
Maintenance of visual acuity is defined as not losing 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters from baseline.
Up to Approximately Week 104
Bilateral portion: Change from baseline in serum anti-sura-vec Transgene product (TP) antibodies
時間枠：Up to Approximately Week 104
Change from baseline in serum anti-sura-vec antibodies
Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Central Retinal Thickness (CRT) on Spectral Domain-Optical Coherence Tomography (SD-OCT)
時間枠：Up to Approximately Week 104
Change from baseline in CRT on SD-OCT.
Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Aqueous Humor Surabgene Lomparvovec (Sura-vec) Transgene product (TP) Concentration
時間枠：Up to Approximately Week 104
Change from baseline in aqueous humor sura-vec TP concentration.
Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Serum Sura-vec Transgene product (TP) concentration
時間枠：Up to Approximately Week 104
Change from baseline in serum sura-vec TP concentration.
Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Anti- Associated Virus Serotype 8 (AAV8) Transgene product (TP) antibodies
時間枠：Up to Approximately Week 104
Change from baseline in serum anti-AAV8 TP antibodies.
Up to Approximately Week 104
Bilateral Portion: Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
時間枠：Up to Approximately Week 104
Participants will be assessed for the development of VTEs
Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Enzyme-linked ImmunoSpot (ELISpot to capsid or transgene)
時間枠：Up to Approximately Week 104
Change from baseline in ELISpot comparing (whole blood) to capsid or transgene.
Up to Approximately 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

AbbVie

捜査官

  • スタディディレクター：ABBVIE INC.、AbbVie

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

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 (実際)

2026年6月1日

一次修了 (推定)

2028年6月1日

研究の完了 (推定)

2036年1月1日

試験登録日

最初に提出

2026年4月24日

QC基準を満たした最初の提出物

2026年5月11日

最初の投稿 (実際)

2026年5月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月10日

QC基準を満たした最後の更新が送信されました

2026年9月8日

最終確認日

2026年9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

  • M23-415

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?

はい

IPD プランの説明

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD 共有時間枠

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD 共有アクセス基準

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

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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