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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15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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

576

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 波多黎各
      • Arecibo、波多黎各、00612
        • 招聘中
        • Emanuelli Research & Development Center /ID# 275378
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85053
        • 招聘中
        • Retinal Consultants Of Arizona - Phoenix - North /ID# 283407
      • Scottsdale、Arizona、美国、85255-4134
        • 招聘中
        • Retina Macula Institute of Arizona /ID# 282881
      • Sun City、Arizona、美国、85351
        • 招聘中
        • Barnet Dulaney Perkins Eye Center - Sun City /ID# 283000
    • California
      • Bakersfield、California、美国、93309
        • 招聘中
        • California Retina Consultants - Bakersfield /ID# 282990
      • Encino、California、美国、91436
        • 招聘中
        • The Retina Partners /ID# 274741
      • Mountain View、California、美国、94040-4119
        • 招聘中
        • Northern California Retina Vitreous Associates /ID# 282994
      • Pasadena、California、美国、91107
        • 招聘中
        • California Eye Specialists Medical Group /ID# 274705
      • Poway、California、美国、92064
        • 招聘中
        • Retina Consultants San Diego /ID# 274748
      • San Francisco、California、美国、94109
        • 招聘中
        • West Coast Retinal Medical Group /ID# 283007
      • Torrance、California、美国、90503
        • 招聘中
        • Macula Retina Vitreous Center - Torrance /ID# 282878
      • Walnut Creek、California、美国、94598-5910
        • 招聘中
        • Bay Area Retina Associates /ID# 275032
    • Colorado
      • Durango、Colorado、美国、81303
        • 招聘中
        • Southwest Retina Research Center /ID# 276094
      • Lakewood、Colorado、美国、80228
        • 招聘中
        • Colorado Retina Associates /ID# 283006
      • Longmont、Colorado、美国、80503
        • 招聘中
        • Advanced Vision Surgery Center /ID# 275017
    • Florida
      • Lakeland、Florida、美国、33805
        • 招聘中
        • Florida Retina Consultants - Lakeland /ID# 275012
      • Orlando、Florida、美国、32806
        • 招聘中
        • Florida Retina Institute - Orlando /ID# 283034
      • Pensacola、Florida、美国、32503
        • 招聘中
        • Retina Speciality Institute /ID# 274996
    • Georgia
      • Augusta、Georgia、美国、30909
        • 招聘中
        • Southeast Retina Center /ID# 274739
    • Illinois
      • Chicago、Illinois、美国、60657
        • 招聘中
        • Illinois Retina Associates S.C /ID# 283048
      • Oak Forest、Illinois、美国、60452
        • 招聘中
        • University Retina - Oak Forest /ID# 283021
      • Springfield、Illinois、美国、62702
        • 招聘中
        • Springfield Clinic - First /ID# 283028
    • Kansas
      • Lenexa、Kansas、美国、66215
        • 招聘中
        • Retina Associates - Lenexa /ID# 283004
    • Maine
      • Portland、Maine、美国、04101
        • 招聘中
        • Maine Eye Center - Marginal Way Campus /ID# 275039
    • Maryland
      • Hagerstown、Maryland、美国、21740
        • 招聘中
        • Mid Atlantic Retina Specialists - Hagerstown /ID# 274725
    • Nevada
      • Reno、Nevada、美国、89502
        • 招聘中
        • Sierra Eye Associates /ID# 274737
    • New Jersey
      • Bloomfield、New Jersey、美国、07003
        • 招聘中
        • Retina Center Of New Jersey /ID# 283088
    • Ohio
      • Beachwood、Ohio、美国、44122
        • 招聘中
        • Retina Associates Of Cleveland - Beachwood /ID# 275985
    • South Carolina
      • Charleston、South Carolina、美国、29414
        • 招聘中
        • Charleston Neuroscience Institute - Charleston /ID# 275047
    • Texas
      • Austin、Texas、美国、78705
        • 招聘中
        • Austin Research Center for Retina /ID# 276101
      • Burleson、Texas、美国、76028
        • 招聘中
        • Star Retina /ID# 276513
      • Dallas、Texas、美国、75231
        • 招聘中
        • Texas Retina Associates - Dallas /ID# 276117
    • Virginia
      • Salem、Virginia、美国、24153
        • 招聘中
        • Vistar Eye Center - Salem /ID# 282879

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：Surabgene Lomparvovec
Solution Injection
药品：Topical Steroid
Topical Drops
实验性的：Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B
Participants will receive a single SCS injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen B.
药品：Surabgene Lomparvovec
Solution Injection
药品：Topical Steroid
Topical Drops
安慰剂比较：Phase 2b: Sham + Artificial Tears -Regimen A
Participants will receive a single injection of sham+ artificial tears -Regimen A.
药品：Sham
needleless injection without fluid
药品：Artificial Tears
Topical Drops
安慰剂比较：Phase 2b: Sham + Artificial Tears -Regimen B
Participants will receive a single injection of Sham+ artificial tears -Regimen B.
药品：Sham
needleless injection without fluid
药品：Artificial Tears
Topical Drops
实验性的：Phase 3: Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid
药品：Surabgene Lomparvovec
Solution Injection
药品：Topical Steroid
Topical Drops
安慰剂比较：Phase 3: Sham + Artificial Tears
Participants will receive a single injection of Sham + artificial tears.
药品：Sham
needleless injection without fluid
药品：Artificial Tears
Topical Drops
实验性的：Bilateral: B1-Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid eye drops in each eye.
药品：Surabgene Lomparvovec
Solution Injection
药品：Topical Steroid
Topical Drops
实验性的：Bilateral: B2-Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye.
药品：Surabgene Lomparvovec
Solution Injection
药品：Topical Steroid
Topical Drops

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：Up to Approximately Week 104
Percentage of participants who experience scleral inflammation including episcleritis.
Up to Approximately Week 104

次要结果测量

结果测量
措施说明
大体时间
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
大体时间：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.
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
大体时间：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.
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：Up to Approximately Week 104
Change from baseline in ELISpot comparing (whole blood) to capsid or transgene.
Up to Approximately Week 104

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AbbVie

调查人员

  • 研究主任：ABBVIE INC.、AbbVie

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2036年1月1日

研究注册日期

首次提交

2026年4月24日

首先提交符合 QC 标准的

2026年5月11日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • M23-415

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

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

IPD 共享访问标准

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

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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