Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema (NAAVIGATE)
2026년 9월 15일 업데이트: 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.
연구 개요
상태
모병
정황
연구 유형
중재적
등록 (추정된)
576
단계
- 2 단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: ABBVIE CALL CENTER
- 전화번호: 844-663-3742
- 이메일: abbvieclinicaltrials@abbvie.com
연구 장소
-
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Arizona
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Phoenix, Arizona, 미국, 85053
- 모병
- Retinal Consultants Of Arizona - Phoenix - North /ID# 283407
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Scottsdale, Arizona, 미국, 85255-4134
- 모병
- Retina Macula Institute of Arizona /ID# 282881
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Sun City, Arizona, 미국, 85351
- 모병
- Barnet Dulaney Perkins Eye Center - Sun City /ID# 283000
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California
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Bakersfield, California, 미국, 93309
- 모병
- California Retina Consultants - Bakersfield /ID# 282990
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Encino, California, 미국, 91436
- 모병
- The Retina Partners /ID# 274741
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Mountain View, California, 미국, 94040-4119
- 모병
- Northern California Retina Vitreous Associates /ID# 282994
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Pasadena, California, 미국, 91107
- 모병
- California Eye Specialists Medical Group /ID# 274705
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Poway, California, 미국, 92064
- 모병
- Retina Consultants San Diego /ID# 274748
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San Francisco, California, 미국, 94109
- 모병
- West Coast Retinal Medical Group /ID# 283007
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Torrance, California, 미국, 90503
- 모병
- Macula Retina Vitreous Center - Torrance /ID# 282878
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Walnut Creek, California, 미국, 94598-5910
- 모병
- Bay Area Retina Associates /ID# 275032
-
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Colorado
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Durango, Colorado, 미국, 81303
- 모병
- Southwest Retina Research Center /ID# 276094
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Lakewood, Colorado, 미국, 80228
- 모병
- Colorado Retina Associates /ID# 283006
-
Longmont, Colorado, 미국, 80503
- 모병
- Advanced Vision Surgery Center /ID# 275017
-
-
Florida
-
Lakeland, Florida, 미국, 33805
- 모병
- Florida Retina Consultants - Lakeland /ID# 275012
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Orlando, Florida, 미국, 32806
- 모병
- Florida Retina Institute - Orlando /ID# 283034
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Pensacola, Florida, 미국, 32503
- 모병
- Retina Speciality Institute /ID# 274996
-
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Georgia
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Augusta, Georgia, 미국, 30909
- 모병
- Southeast Retina Center /ID# 274739
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Illinois
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Chicago, Illinois, 미국, 60657
- 모병
- Illinois Retina Associates S.C /ID# 283048
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Oak Forest, Illinois, 미국, 60452
- 모병
- University Retina - Oak Forest /ID# 283021
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Springfield, Illinois, 미국, 62702
- 모병
- Springfield Clinic - First /ID# 283028
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Kansas
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Lenexa, Kansas, 미국, 66215
- 모병
- Retina Associates - Lenexa /ID# 283004
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Maine
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Portland, Maine, 미국, 04101
- 모병
- Maine Eye Center - Marginal Way Campus /ID# 275039
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Maryland
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Hagerstown, Maryland, 미국, 21740
- 모병
- Mid Atlantic Retina Specialists - Hagerstown /ID# 274725
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Nevada
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Reno, Nevada, 미국, 89502
- 모병
- Sierra Eye Associates /ID# 274737
-
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New Jersey
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Bloomfield, New Jersey, 미국, 07003
- 모병
- Retina Center Of New Jersey /ID# 283088
-
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Ohio
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Beachwood, Ohio, 미국, 44122
- 모병
- Retina Associates Of Cleveland - Beachwood /ID# 275985
-
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South Carolina
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Charleston, South Carolina, 미국, 29414
- 모병
- Charleston Neuroscience Institute - Charleston /ID# 275047
-
-
Texas
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Austin, Texas, 미국, 78705
- 모병
- Austin Research Center for Retina /ID# 276101
-
Burleson, Texas, 미국, 76028
- 모병
- Star Retina /ID# 276513
-
Dallas, Texas, 미국, 75231
- 모병
- Texas Retina Associates - Dallas /ID# 276117
-
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Virginia
-
Salem, Virginia, 미국, 24153
- 모병
- Vistar Eye Center - Salem /ID# 282879
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-
-
-
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Arecibo, 푸에르토 리코, 00612
- 모병
- Emanuelli Research & Development Center /ID# 275378
-
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
Solution Injection
Topical Drops
|
|
실험적: Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B
Participants will receive a single SCS injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen B.
|
Solution Injection
Topical Drops
|
|
위약 비교기: Phase 2b: Sham + Artificial Tears -Regimen A
Participants will receive a single injection of sham+ artificial tears -Regimen A.
|
needleless injection without fluid
Topical Drops
|
|
위약 비교기: Phase 2b: Sham + Artificial Tears -Regimen B
Participants will receive a single injection of Sham+ artificial tears -Regimen B.
|
needleless injection without fluid
Topical Drops
|
|
실험적: Phase 3: Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid
|
Solution Injection
Topical Drops
|
|
위약 비교기: Phase 3: Sham + Artificial Tears
Participants will receive a single injection of Sham + artificial tears.
|
needleless injection without fluid
Topical Drops
|
|
실험적: Bilateral: B1-Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid eye drops in each eye.
|
Solution Injection
Topical Drops
|
|
실험적: Bilateral: B2-Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye.
|
Solution Injection
Topical Drops
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
기간: 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
기간: 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)
기간: 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
기간: 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
기간: Up to Approximately Week 104
|
Percentage of participants who experience scleral inflammation including episcleritis.
|
Up to Approximately Week 104
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: Up to Approximately Week 104
|
Change from baseline in ELISpot comparing (whole blood) to capsid or transgene.
|
Up to Approximately Week 104
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: ABBVIE INC., AbbVie
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 1일
기본 완료 (추정된)
2028년 6월 1일
연구 완료 (추정된)
2036년 1월 1일
연구 등록 날짜
최초 제출
2026년 4월 24일
QC 기준을 충족하는 최초 제출
2026년 5월 11일
처음 게시됨 (실제)
2026년 5월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 15일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- M23-415
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 공유 액세스 기준
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .