Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema (NAAVIGATE)
15 september 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
576
Fas
- Fas 2
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-post: abbvieclinicaltrials@abbvie.com
Studieorter
-
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Arizona
-
Phoenix, Arizona, Förenta staterna, 85053
- Rekrytering
- Retinal Consultants Of Arizona - Phoenix - North /ID# 283407
-
Scottsdale, Arizona, Förenta staterna, 85255-4134
- Rekrytering
- Retina Macula Institute of Arizona /ID# 282881
-
Sun City, Arizona, Förenta staterna, 85351
- Rekrytering
- Barnet Dulaney Perkins Eye Center - Sun City /ID# 283000
-
-
California
-
Bakersfield, California, Förenta staterna, 93309
- Rekrytering
- California Retina Consultants - Bakersfield /ID# 282990
-
Encino, California, Förenta staterna, 91436
- Rekrytering
- The Retina Partners /ID# 274741
-
Mountain View, California, Förenta staterna, 94040-4119
- Rekrytering
- Northern California Retina Vitreous Associates /ID# 282994
-
Pasadena, California, Förenta staterna, 91107
- Rekrytering
- California Eye Specialists Medical Group /ID# 274705
-
Poway, California, Förenta staterna, 92064
- Rekrytering
- Retina Consultants San Diego /ID# 274748
-
San Francisco, California, Förenta staterna, 94109
- Rekrytering
- West Coast Retinal Medical Group /ID# 283007
-
Torrance, California, Förenta staterna, 90503
- Rekrytering
- Macula Retina Vitreous Center - Torrance /ID# 282878
-
Walnut Creek, California, Förenta staterna, 94598-5910
- Rekrytering
- Bay Area Retina Associates /ID# 275032
-
-
Colorado
-
Durango, Colorado, Förenta staterna, 81303
- Rekrytering
- Southwest Retina Research Center /ID# 276094
-
Lakewood, Colorado, Förenta staterna, 80228
- Rekrytering
- Colorado Retina Associates /ID# 283006
-
Longmont, Colorado, Förenta staterna, 80503
- Rekrytering
- Advanced Vision Surgery Center /ID# 275017
-
-
Florida
-
Lakeland, Florida, Förenta staterna, 33805
- Rekrytering
- Florida Retina Consultants - Lakeland /ID# 275012
-
Orlando, Florida, Förenta staterna, 32806
- Rekrytering
- Florida Retina Institute - Orlando /ID# 283034
-
Pensacola, Florida, Förenta staterna, 32503
- Rekrytering
- Retina Speciality Institute /ID# 274996
-
-
Georgia
-
Augusta, Georgia, Förenta staterna, 30909
- Rekrytering
- Southeast Retina Center /ID# 274739
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60657
- Rekrytering
- Illinois Retina Associates S.C /ID# 283048
-
Oak Forest, Illinois, Förenta staterna, 60452
- Rekrytering
- University Retina - Oak Forest /ID# 283021
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Springfield, Illinois, Förenta staterna, 62702
- Rekrytering
- Springfield Clinic - First /ID# 283028
-
-
Kansas
-
Lenexa, Kansas, Förenta staterna, 66215
- Rekrytering
- Retina Associates - Lenexa /ID# 283004
-
-
Maine
-
Portland, Maine, Förenta staterna, 04101
- Rekrytering
- Maine Eye Center - Marginal Way Campus /ID# 275039
-
-
Maryland
-
Hagerstown, Maryland, Förenta staterna, 21740
- Rekrytering
- Mid Atlantic Retina Specialists - Hagerstown /ID# 274725
-
-
Nevada
-
Reno, Nevada, Förenta staterna, 89502
- Rekrytering
- Sierra Eye Associates /ID# 274737
-
-
New Jersey
-
Bloomfield, New Jersey, Förenta staterna, 07003
- Rekrytering
- Retina Center Of New Jersey /ID# 283088
-
-
Ohio
-
Beachwood, Ohio, Förenta staterna, 44122
- Rekrytering
- Retina Associates Of Cleveland - Beachwood /ID# 275985
-
-
South Carolina
-
Charleston, South Carolina, Förenta staterna, 29414
- Rekrytering
- Charleston Neuroscience Institute - Charleston /ID# 275047
-
-
Texas
-
Austin, Texas, Förenta staterna, 78705
- Rekrytering
- Austin Research Center for Retina /ID# 276101
-
Burleson, Texas, Förenta staterna, 76028
- Rekrytering
- Star Retina /ID# 276513
-
Dallas, Texas, Förenta staterna, 75231
- Rekrytering
- Texas Retina Associates - Dallas /ID# 276117
-
-
Virginia
-
Salem, Virginia, Förenta staterna, 24153
- Rekrytering
- Vistar Eye Center - Salem /ID# 282879
-
-
-
-
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Arecibo, Puerto Rico, 00612
- Rekrytering
- Emanuelli Research & Development Center /ID# 275378
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Placebo-jämförare: 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
|
|
Placebo-jämförare: 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
|
|
Experimentell: Phase 3: Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid
|
Solution Injection
Topical Drops
|
|
Placebo-jämförare: Phase 3: Sham + Artificial Tears
Participants will receive a single injection of Sham + artificial tears.
|
needleless injection without fluid
Topical Drops
|
|
Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: Up to Approximately Week 104
|
Percentage of participants who experience scleral inflammation including episcleritis.
|
Up to Approximately Week 104
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: Up to Approximately Week 104
|
Change from baseline in ELISpot comparing (whole blood) to capsid or transgene.
|
Up to Approximately Week 104
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: ABBVIE INC., AbbVie
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2026
Primärt slutförande (Beräknad)
1 juni 2028
Avslutad studie (Beräknad)
1 januari 2036
Studieregistreringsdatum
Först inskickad
24 april 2026
Först inskickad som uppfyllde QC-kriterierna
11 maj 2026
Första postat (Faktisk)
18 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Diabetes mellitus
- Ögonsjukdomar
- Diabetiska angiopatier
- Diabeteskomplikationer
- Näthinnesjukdomar
- Diabetisk retinopati
- Oftalmiska lösningar
- Farmaceutiska lösningar
- Farmaceutiska förberedelser
- Farmakologiska åtgärder
- Kemiska åtgärder och användningar
- Terapeutisk användning
- Polycykliska föreningar
- Fusion-ringföreningar
- Lösningar
- Specialanvändning av kemikalier
- Smörjmedel
- Smörjmedel ögondroppar
- salicylhydroxaminsyra
- Steroider
Andra studie-ID-nummer
- M23-415
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Kriterier för IPD Sharing Access
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .