Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema (NAAVIGATE)
15 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
576
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: ABBVIE CALL CENTER
- Numéro de téléphone: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Lieux d'étude
-
-
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Arecibo, Porto Rico, 00612
- Recrutement
- Emanuelli Research & Development Center /ID# 275378
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-
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Arizona
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Phoenix, Arizona, États-Unis, 85053
- Recrutement
- Retinal Consultants Of Arizona - Phoenix - North /ID# 283407
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Scottsdale, Arizona, États-Unis, 85255-4134
- Recrutement
- Retina Macula Institute of Arizona /ID# 282881
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Sun City, Arizona, États-Unis, 85351
- Recrutement
- Barnet Dulaney Perkins Eye Center - Sun City /ID# 283000
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California
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Bakersfield, California, États-Unis, 93309
- Recrutement
- California Retina Consultants - Bakersfield /ID# 282990
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Encino, California, États-Unis, 91436
- Recrutement
- The Retina Partners /ID# 274741
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Mountain View, California, États-Unis, 94040-4119
- Recrutement
- Northern California Retina Vitreous Associates /ID# 282994
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Pasadena, California, États-Unis, 91107
- Recrutement
- California Eye Specialists Medical Group /ID# 274705
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Poway, California, États-Unis, 92064
- Recrutement
- Retina Consultants San Diego /ID# 274748
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San Francisco, California, États-Unis, 94109
- Recrutement
- West Coast Retinal Medical Group /ID# 283007
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Torrance, California, États-Unis, 90503
- Recrutement
- Macula Retina Vitreous Center - Torrance /ID# 282878
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Walnut Creek, California, États-Unis, 94598-5910
- Recrutement
- Bay Area Retina Associates /ID# 275032
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Colorado
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Durango, Colorado, États-Unis, 81303
- Recrutement
- Southwest Retina Research Center /ID# 276094
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Lakewood, Colorado, États-Unis, 80228
- Recrutement
- Colorado Retina Associates /ID# 283006
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Longmont, Colorado, États-Unis, 80503
- Recrutement
- Advanced Vision Surgery Center /ID# 275017
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Florida
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Lakeland, Florida, États-Unis, 33805
- Recrutement
- Florida Retina Consultants - Lakeland /ID# 275012
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Orlando, Florida, États-Unis, 32806
- Recrutement
- Florida Retina Institute - Orlando /ID# 283034
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Pensacola, Florida, États-Unis, 32503
- Recrutement
- Retina Speciality Institute /ID# 274996
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Georgia
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Augusta, Georgia, États-Unis, 30909
- Recrutement
- Southeast Retina Center /ID# 274739
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Illinois
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Chicago, Illinois, États-Unis, 60657
- Recrutement
- Illinois Retina Associates S.C /ID# 283048
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Oak Forest, Illinois, États-Unis, 60452
- Recrutement
- University Retina - Oak Forest /ID# 283021
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Springfield, Illinois, États-Unis, 62702
- Recrutement
- Springfield Clinic - First /ID# 283028
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Kansas
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Lenexa, Kansas, États-Unis, 66215
- Recrutement
- Retina Associates - Lenexa /ID# 283004
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Maine
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Portland, Maine, États-Unis, 04101
- Recrutement
- Maine Eye Center - Marginal Way Campus /ID# 275039
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Maryland
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Hagerstown, Maryland, États-Unis, 21740
- Recrutement
- Mid Atlantic Retina Specialists - Hagerstown /ID# 274725
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Nevada
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Reno, Nevada, États-Unis, 89502
- Recrutement
- Sierra Eye Associates /ID# 274737
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New Jersey
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Bloomfield, New Jersey, États-Unis, 07003
- Recrutement
- Retina Center Of New Jersey /ID# 283088
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Ohio
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Beachwood, Ohio, États-Unis, 44122
- Recrutement
- Retina Associates Of Cleveland - Beachwood /ID# 275985
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South Carolina
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Charleston, South Carolina, États-Unis, 29414
- Recrutement
- Charleston Neuroscience Institute - Charleston /ID# 275047
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Texas
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Austin, Texas, États-Unis, 78705
- Recrutement
- Austin Research Center for Retina /ID# 276101
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Burleson, Texas, États-Unis, 76028
- Recrutement
- Star Retina /ID# 276513
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Dallas, Texas, États-Unis, 75231
- Recrutement
- Texas Retina Associates - Dallas /ID# 276117
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Virginia
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Salem, Virginia, États-Unis, 24153
- Recrutement
- Vistar Eye Center - Salem /ID# 282879
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Comparateur 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
|
|
Comparateur 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
|
|
Expérimental: Phase 3: Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid
|
Solution Injection
Topical Drops
|
|
Comparateur placebo: Phase 3: Sham + Artificial Tears
Participants will receive a single injection of Sham + artificial tears.
|
needleless injection without fluid
Topical Drops
|
|
Expérimental: 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
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: Up to Approximately Week 104
|
Percentage of participants who experience scleral inflammation including episcleritis.
|
Up to Approximately Week 104
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: Up to Approximately Week 104
|
Change from baseline in ELISpot comparing (whole blood) to capsid or transgene.
|
Up to Approximately Week 104
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: ABBVIE INC., AbbVie
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2026
Achèvement primaire (Estimé)
1 juin 2028
Achèvement de l'étude (Estimé)
1 janvier 2036
Dates d'inscription aux études
Première soumission
24 avril 2026
Première soumission répondant aux critères de contrôle qualité
11 mai 2026
Première publication (Réel)
18 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Maladies vasculaires
- Maladies cardiovasculaires
- Diabète sucré
- Maladies oculaires
- Angiopathies diabétiques
- Complications du diabète
- Maladies rétiniennes
- La rétinopathie diabétique
- Solutions ophtalmiques
- Solutions pharmaceutiques
- Préparations pharmaceutiques
- Actions pharmacologiques
- Actions et utilisations chimiques
- Utilisations thérapeutiques
- Composés polycycliques
- Composés à anneau fusionné
- Solutions
- Utilisations spéciales de produits chimiques
- Lubrifiants
- Gouttes oculaires lubrifiantes
- acide salicylhydroxamique
- Stéroïdes
Autres numéros d'identification d'étude
- M23-415
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Critères d'accès au partage IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .