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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema (NAAVIGATE)

2. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

576

Phase

  • Phase 2
  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • California
      • Mountain View, California, Vereinigte Staaten, 94040-4119
        • Rekrutierung
        • Northern California Retina Vitreous Associates /ID# 282994
    • Illinois
      • Oak Forest, Illinois, Vereinigte Staaten, 60452
        • Rekrutierung
        • University Retina - Oak Forest /ID# 283021
    • Texas
      • Austin, Texas, Vereinigte Staaten, 78705
        • Rekrutierung
        • Austin Research Center for Retina /ID# 276101

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: Surabgene Lomparvovec
Solution Injection
Arzneimittel: 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.
Arzneimittel: Surabgene Lomparvovec
Solution Injection
Arzneimittel: Topical Steroid
Topical Drops
Placebo-Komparator: Phase 2b: Sham + Artificial Tears -Regimen A
Participants will receive a single injection of sham+ artificial tears -Regimen A.
Arzneimittel: Sham
needleless injection without fluid
Arzneimittel: Artificial Tears
Topical Drops
Placebo-Komparator: Phase 2b: Sham + Artificial Tears -Regimen B
Participants will receive a single injection of Sham+ artificial tears -Regimen B.
Arzneimittel: Sham
needleless injection without fluid
Arzneimittel: Artificial Tears
Topical Drops
Experimental: Phase 3: Surabgene Lomparvovec + Steroid
Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid
Arzneimittel: Surabgene Lomparvovec
Solution Injection
Arzneimittel: Topical Steroid
Topical Drops
Placebo-Komparator: Phase 3: Sham + Artificial Tears
Participants will receive a single injection of Sham + artificial tears.
Arzneimittel: Sham
needleless injection without fluid
Arzneimittel: 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.
Arzneimittel: Surabgene Lomparvovec
Solution Injection
Arzneimittel: 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.
Arzneimittel: Surabgene Lomparvovec
Solution Injection
Arzneimittel: Topical Steroid
Topical Drops

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to Approximately Week 104
Percentage of participants who experience scleral inflammation including episcleritis.
Up to Approximately Week 104

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Up to Approximately Week 104
Change from baseline in ELISpot comparing (whole blood) to capsid or transgene.
Up to Approximately Week 104

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AbbVie

Ermittler

  • Studienleiter: ABBVIE INC., AbbVie

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

20. Mai 2026

Primärer Abschluss (Geschätzt)

1. Juni 2028

Studienabschluss (Geschätzt)

1. Januar 2036

Studienanmeldedaten

Zuerst eingereicht

24. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Mai 2026

Zuerst gepostet (Tatsächlich)

18. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • M23-415

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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