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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 de septiembre de 2026 actualizado 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

576

Fase

  • Fase 2
  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Droga: Surabgene Lomparvovec
Solution Injection
Droga: Topical Steroid
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.
Droga: Surabgene Lomparvovec
Solution Injection
Droga: Topical Steroid
Topical Drops
Comparador de placebos: Phase 2b: Sham + Artificial Tears -Regimen A
Participants will receive a single injection of sham+ artificial tears -Regimen A.
Droga: Sham
needleless injection without fluid
Droga: Artificial Tears
Topical Drops
Comparador de placebos: Phase 2b: Sham + Artificial Tears -Regimen B
Participants will receive a single injection of Sham+ artificial tears -Regimen B.
Droga: Sham
needleless injection without fluid
Droga: Artificial Tears
Topical Drops
Experimental: Phase 3: Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid
Droga: Surabgene Lomparvovec
Solution Injection
Droga: Topical Steroid
Topical Drops
Comparador de placebos: Phase 3: Sham + Artificial Tears
Participants will receive a single injection of Sham + artificial tears.
Droga: Sham
needleless injection without fluid
Droga: Artificial Tears
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.
Droga: Surabgene Lomparvovec
Solution Injection
Droga: Topical Steroid
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.
Droga: Surabgene Lomparvovec
Solution Injection
Droga: Topical Steroid
Topical Drops

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to Approximately Week 104
Percentage of participants who experience scleral inflammation including episcleritis.
Up to Approximately Week 104

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AbbVie

Investigadores

  • Director de estudio: ABBVIE INC., AbbVie

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2026

Finalización primaria (Estimado)

1 de junio de 2028

Finalización del estudio (Estimado)

1 de enero de 2036

Fechas de registro del estudio

Enviado por primera vez

24 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de mayo de 2026

Publicado por primera vez (Actual)

18 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • M23-415

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de 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 información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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