Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema (NAAVIGATE)
15 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
576
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: ABBVIE CALL CENTER
- Número de telefone: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Locais de estudo
-
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Arizona
-
Phoenix, Arizona, Estados Unidos, 85053
- Recrutamento
- Retinal Consultants Of Arizona - Phoenix - North /ID# 283407
-
Scottsdale, Arizona, Estados Unidos, 85255-4134
- Recrutamento
- Retina Macula Institute of Arizona /ID# 282881
-
Sun City, Arizona, Estados Unidos, 85351
- Recrutamento
- Barnet Dulaney Perkins Eye Center - Sun City /ID# 283000
-
-
California
-
Bakersfield, California, Estados Unidos, 93309
- Recrutamento
- California Retina Consultants - Bakersfield /ID# 282990
-
Encino, California, Estados Unidos, 91436
- Recrutamento
- The Retina Partners /ID# 274741
-
Mountain View, California, Estados Unidos, 94040-4119
- Recrutamento
- Northern California Retina Vitreous Associates /ID# 282994
-
Pasadena, California, Estados Unidos, 91107
- Recrutamento
- California Eye Specialists Medical Group /ID# 274705
-
Poway, California, Estados Unidos, 92064
- Recrutamento
- Retina Consultants San Diego /ID# 274748
-
San Francisco, California, Estados Unidos, 94109
- Recrutamento
- West Coast Retinal Medical Group /ID# 283007
-
Torrance, California, Estados Unidos, 90503
- Recrutamento
- Macula Retina Vitreous Center - Torrance /ID# 282878
-
Walnut Creek, California, Estados Unidos, 94598-5910
- Recrutamento
- Bay Area Retina Associates /ID# 275032
-
-
Colorado
-
Durango, Colorado, Estados Unidos, 81303
- Recrutamento
- Southwest Retina Research Center /ID# 276094
-
Lakewood, Colorado, Estados Unidos, 80228
- Recrutamento
- Colorado Retina Associates /ID# 283006
-
Longmont, Colorado, Estados Unidos, 80503
- Recrutamento
- Advanced Vision Surgery Center /ID# 275017
-
-
Florida
-
Lakeland, Florida, Estados Unidos, 33805
- Recrutamento
- Florida Retina Consultants - Lakeland /ID# 275012
-
Orlando, Florida, Estados Unidos, 32806
- Recrutamento
- Florida Retina Institute - Orlando /ID# 283034
-
Pensacola, Florida, Estados Unidos, 32503
- Recrutamento
- Retina Speciality Institute /ID# 274996
-
-
Georgia
-
Augusta, Georgia, Estados Unidos, 30909
- Recrutamento
- Southeast Retina Center /ID# 274739
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60657
- Recrutamento
- Illinois Retina Associates S.C /ID# 283048
-
Oak Forest, Illinois, Estados Unidos, 60452
- Recrutamento
- University Retina - Oak Forest /ID# 283021
-
Springfield, Illinois, Estados Unidos, 62702
- Recrutamento
- Springfield Clinic - First /ID# 283028
-
-
Kansas
-
Lenexa, Kansas, Estados Unidos, 66215
- Recrutamento
- Retina Associates - Lenexa /ID# 283004
-
-
Maine
-
Portland, Maine, Estados Unidos, 04101
- Recrutamento
- Maine Eye Center - Marginal Way Campus /ID# 275039
-
-
Maryland
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Hagerstown, Maryland, Estados Unidos, 21740
- Recrutamento
- Mid Atlantic Retina Specialists - Hagerstown /ID# 274725
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Nevada
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Reno, Nevada, Estados Unidos, 89502
- Recrutamento
- Sierra Eye Associates /ID# 274737
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New Jersey
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Bloomfield, New Jersey, Estados Unidos, 07003
- Recrutamento
- Retina Center Of New Jersey /ID# 283088
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-
Ohio
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Beachwood, Ohio, Estados Unidos, 44122
- Recrutamento
- Retina Associates Of Cleveland - Beachwood /ID# 275985
-
-
South Carolina
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Charleston, South Carolina, Estados Unidos, 29414
- Recrutamento
- Charleston Neuroscience Institute - Charleston /ID# 275047
-
-
Texas
-
Austin, Texas, Estados Unidos, 78705
- Recrutamento
- Austin Research Center for Retina /ID# 276101
-
Burleson, Texas, Estados Unidos, 76028
- Recrutamento
- Star Retina /ID# 276513
-
Dallas, Texas, Estados Unidos, 75231
- Recrutamento
- Texas Retina Associates - Dallas /ID# 276117
-
-
Virginia
-
Salem, Virginia, Estados Unidos, 24153
- Recrutamento
- Vistar Eye Center - Salem /ID# 282879
-
-
-
-
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Arecibo, Porto Rico, 00612
- Recrutamento
- Emanuelli Research & Development Center /ID# 275378
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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
|
|
Experimental: 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
|
|
Comparador de Placebo: 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
|
|
Comparador de Placebo: 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
|
|
Experimental: Phase 3: Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid
|
Solution Injection
Topical Drops
|
|
Comparador de Placebo: Phase 3: Sham + Artificial Tears
Participants will receive a single injection of Sham + artificial tears.
|
needleless injection without fluid
Topical Drops
|
|
Experimental: 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
|
|
Experimental: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: Up to Approximately Week 104
|
Percentage of participants who experience scleral inflammation including episcleritis.
|
Up to Approximately Week 104
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: Up to Approximately Week 104
|
Change from baseline in ELISpot comparing (whole blood) to capsid or transgene.
|
Up to Approximately Week 104
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: ABBVIE INC., AbbVie
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2026
Conclusão Primária (Estimado)
1 de junho de 2028
Conclusão do estudo (Estimado)
1 de janeiro de 2036
Datas de inscrição no estudo
Enviado pela primeira vez
24 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de maio de 2026
Primeira postagem (Real)
18 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Doenças Vasculares
- Doenças cardiovasculares
- Diabetes Mellitus
- Doenças oculares
- Angiopatias Diabéticas
- Complicações do Diabetes
- Doenças Retinianas
- Retinopatia diabética
- Soluções oftálmicas
- Soluções Farmacêuticas
- Preparações farmacêuticas
- Ações farmacológicas
- Ações e usos químicos
- Usos terapêuticos
- Compostos policíclicos
- Compostos de anel fundido
- Soluções
- Usos especializados de produtos químicos
- Lubrificantes
- Colírio Lubrificante
- Ácido salicil -hidroxâmico
- Esteróides
Outros números de identificação do estudo
- M23-415
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Critérios de acesso de compartilhamento IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .