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

15 сентября 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

576

Фаза

  • Фаза 2
  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Лекарство: Surabgene Lomparvovec
Solution Injection
Лекарство: Topical Steroid
Topical Drops
Экспериментальный: Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B
Participants will receive a single SCS injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen B.
Лекарство: Surabgene Lomparvovec
Solution Injection
Лекарство: Topical Steroid
Topical Drops
Плацебо Компаратор: Phase 2b: Sham + Artificial Tears -Regimen A
Participants will receive a single injection of sham+ artificial tears -Regimen A.
Лекарство: Sham
needleless injection without fluid
Лекарство: Artificial Tears
Topical Drops
Плацебо Компаратор: Phase 2b: Sham + Artificial Tears -Regimen B
Participants will receive a single injection of Sham+ artificial tears -Regimen B.
Лекарство: Sham
needleless injection without fluid
Лекарство: Artificial Tears
Topical Drops
Экспериментальный: Phase 3: Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid
Лекарство: Surabgene Lomparvovec
Solution Injection
Лекарство: Topical Steroid
Topical Drops
Плацебо Компаратор: Phase 3: Sham + Artificial Tears
Participants will receive a single injection of Sham + artificial tears.
Лекарство: Sham
needleless injection without fluid
Лекарство: Artificial Tears
Topical Drops
Экспериментальный: Bilateral: B1-Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid eye drops in each eye.
Лекарство: Surabgene Lomparvovec
Solution Injection
Лекарство: Topical Steroid
Topical Drops
Экспериментальный: Bilateral: B2-Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye.
Лекарство: Surabgene Lomparvovec
Solution Injection
Лекарство: Topical Steroid
Topical Drops

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Up to Approximately Week 104
Percentage of participants who experience scleral inflammation including episcleritis.
Up to Approximately Week 104

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: Up to Approximately Week 104
Change from baseline in ELISpot comparing (whole blood) to capsid or transgene.
Up to Approximately Week 104

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

AbbVie

Следователи

  • Директор по исследованиям: ABBVIE INC., AbbVie

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 июня 2026 г.

Первичное завершение (Оцененный)

1 июня 2028 г.

Завершение исследования (Оцененный)

1 января 2036 г.

Даты регистрации исследования

Первый отправленный

24 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

11 мая 2026 г.

Первый опубликованный (Действительный)

18 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

17 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

15 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • M23-415

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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.

Сроки обмена IPD

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

Критерии совместного доступа к IPD

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

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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