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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 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Retinopatia diabetica

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

576

Fase

Fase 2
Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: ABBVIE CALL CENTER
Numero di telefono: 844-663-3742
Email: abbvieclinicaltrials@abbvie.com

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Doppio

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: Phase 2b: Surabgene Lomparvovec + Steroid-Regimen A Participants will receive a single Suprachoroidal space (SCS) injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen A.	Droga: Surabgene Lomparvovec Solution Injection Droga: Topical Steroid Topical Drops
Sperimentale: Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B Participants will receive a single SCS injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen B.	Droga: Surabgene Lomparvovec Solution Injection Droga: Topical Steroid Topical Drops
Comparatore placebo: Phase 2b: Sham + Artificial Tears -Regimen A Participants will receive a single injection of sham+ artificial tears -Regimen A.	Droga: Sham needleless injection without fluid Droga: Artificial Tears Topical Drops
Comparatore placebo: Phase 2b: Sham + Artificial Tears -Regimen B Participants will receive a single injection of Sham+ artificial tears -Regimen B.	Droga: Sham needleless injection without fluid Droga: Artificial Tears Topical Drops
Sperimentale: Phase 3: Surabgene Lomparvovec + Steroid Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid	Droga: Surabgene Lomparvovec Solution Injection Droga: Topical Steroid Topical Drops
Comparatore placebo: Phase 3: Sham + Artificial Tears Participants will receive a single injection of Sham + artificial tears.	Droga: Sham needleless injection without fluid Droga: Artificial Tears Topical Drops
Sperimentale: Bilateral: B1-Surabgene Lomparvovec + Steroid Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid eye drops in each eye.	Droga: Surabgene Lomparvovec Solution Injection Droga: Topical Steroid Topical Drops
Sperimentale: Bilateral: B2-Surabgene Lomparvovec + Steroid Participants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye.	Droga: Surabgene Lomparvovec Solution Injection Droga: Topical Steroid Topical Drops

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: Up to Approximately Week 104	Percentage of participants who experience scleral inflammation including episcleritis.	Up to Approximately Week 104

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR) Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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. Lasso di tempo: 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. Lasso di tempo: 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. Lasso di tempo: 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. Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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. Lasso di tempo: 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. Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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. Lasso di tempo: 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. Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: Up to Approximately Week 104	Change from baseline in ELISpot comparing (whole blood) to capsid or transgene.	Up to Approximately Week 104

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AbbVie

Investigatori

Direttore dello studio: ABBVIE INC., AbbVie

Pubblicazioni e link utili

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Collegamenti utili

Related Info

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

20 maggio 2026

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

1 gennaio 2036

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2026

Primo Inserito (Effettivo)

18 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

M23-415

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

STUDIO_PROTOCOLLO
LINFA

Informazioni su farmaci e dispositivi, documenti di studio

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Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Surabgene Lomparvovec

AbbVie

Reclutamento

Studio per valutare l'onere di iniezione, gli eventi avversi, il cambiamento nell'attività della malattia e la conservazione a lungo termine dell'acuità visiva di Surabgene Lomparvovec nei partecipanti adulti con degenerazione maculare legata all'età neovascolare (NAMD)

Degenerazione maculare legata all'età neovascolare

Stati Uniti, Regno Unito, Canada, Spagna, Francia, Germania, Austria, Italia, Bulgaria, Ungheria, Grecia, Israele, Belgio, Portogallo, Croazia, Porto Rico, Cechia
AbbVie
REGENXBIO Inc.

Attivo, non reclutante

Studio cardine 1 sulla terapia genica RGX-314 nei partecipanti con nAMD (ATMOSPHERE)

Neovascolarizzazione coroidale | Degenerazione maculare legata all'età neovascolare | CNV | AMD | nAMD | AMD umida | Degenerazione maculare legata all'età umida | wAMD | AMD neovascolare

Stati Uniti
AbbVie
REGENXBIO Inc.

Reclutamento

Studio cardine 2 della terapia genica RGX-314 nei partecipanti con nAMD (ASCENT)

CNV | AMD | nAMD | Degenerazione maculare legata all'età umida | wAMD | WetAMD

Stati Uniti, Giappone, Germania, Canada, Francia, Ungheria, Italia, Porto Rico, Spagna, Regno Unito

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

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Tipo di studio

Iscrizione (Stimato)

Fase

Contatti e Sedi

Contatto studio

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Investigatori

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Studiare le date dei record

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Inizio studio (Stimato)

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Date di iscrizione allo studio

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Aggiornamenti dei record di studio

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Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

Periodo di condivisione IPD

Criteri di accesso alla condivisione IPD

Tipo di informazioni di supporto alla condivisione IPD

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti

Prove cliniche su Surabgene Lomparvovec

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