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Ixoberogene Soroparvovec (Ixo-vec) Contralateral Dosing Study in Participants With Neovascular Age-related Macular Degeneration

4 août 2026 mis à jour par: Adverum Biotechnologies, Inc.

Evaluation of the Safety and Tolerability of Ixoberogene Soroparvovec (Ixo-vec) Intravitreal Gene Therapy in the Second (Contralateral) Eye of Participants With Bilateral Neovascular Age-related Macular Degeneration.

The purpose of this study is to evaluate safety, effectiveness and durability of a gene therapy called Ixo-vec (Ixoberogene soroparvovec) when administered to the contralateral (second) eye of adult participants (≥ 50 years of age) who have been diagnosed with bilateral neovascular (wet) age related macular degeneration (nAMD). The study will enroll adults with nAMD in both eyes, including participants who previously received Ixo-vec treatment in one (initial) eye and/or participants who will receive Ixo-vec treatment for the first time. This study focuses on how the treatment works when both eyes are treated at different times and how effective and long-lasting Ixo-vec treatment is in the second (contralateral) eye.

Participants will receive a single administration of Ixo-vec in the contralateral eye and will be followed for approximately 5 years to evaluate safety, efficacy and durability of contralateral treatment. Secondary objectives include assessments that will evaluate clinical activity, including visual and anatomic outcomes, as well as the need for supplemental anti-VEGF therapy.

The study is intended to provide additional information on the safety, tolerability, and use of Ixo-vec in bilateral treatment.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a Phase 2, single-arm, open-label, multi-center study in participants who are ≥ 50 years old with a diagnosis of bilateral choroidal neovascularization (CNV) secondary to neovascular (wet) age related macular degeneration (nAMD). This study is designed to evaluate the safety, tolerability, and efficacy of Ixo-vec dosing in the contralateral (second) eye.

The study includes participants who have previously received Ixo-vec in one eye in a prior clinical study, as well as Ixo-vec-naïve participants eligible for sequential bilateral administration. The study will evaluate the use of Ixo-vec when both eyes are treated at different time points.

Neovascular AMD is a progressive retinal disease characterized by the growth of abnormal blood vessels originating from the choroid, which can lead to vision loss. Current standard of care includes repeated intravitreal (IVT) administration of anti-vascular endothelial growth factor (anti-VEGF) therapies.

Ixo-vec (also known as Ixoberogene soroparvovec, ADVM-022 or AAV.7m8-aflibercept) is an adeno-associated virus (AAV)-based gene therapy designed to enable sustained intraocular expression of an anti-VEGF protein following a single IVT administration.

The primary objective of this study is to assess the safety and tolerability of Ixo-vec administered to the contralateral eye. Secondary objectives include assessments that will evaluate clinical activity, including visual and anatomic outcomes, as well as the need for supplemental anti-VEGF therapy over time.

Type d'étude

Interventionnel

Inscription (Estimé)

15

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Arizona
      • Phoenix, Arizona, États-Unis, 85053
        • Recrutement
        • Adverum site 126
    • California
      • Bakersfield, California, États-Unis, 93309
        • Recrutement
        • Adverum site 109
      • Fullerton, California, États-Unis, 92835
        • Recrutement
        • Adverum site 169
    • Florida
      • Deerfield Beach, Florida, États-Unis, 33064
        • Recrutement
        • Adverum site 124
      • Fort Lauderdale, Florida, États-Unis, 33308
        • Recrutement
        • Adverum site 176
      • Jacksonville, Florida, États-Unis, 32216
        • Recrutement
        • Adverum site 168
    • Hawaii
      • ‘Aiea, Hawaii, États-Unis, 96701
        • Recrutement
        • Adverum site 149
    • Illinois
      • Lemont, Illinois, États-Unis, 60439
        • Recrutement
        • Adverum site 179
    • New Jersey
      • Teaneck, New Jersey, États-Unis, 07666
        • Recrutement
        • Adverum site 171
    • South Carolina
      • West Columbia, South Carolina, États-Unis, 29169
        • Recrutement
        • Adverum site 122
    • Texas
      • The Woodlands, Texas, États-Unis, 77384
        • Recrutement
        • Adverum site 107
      • The Woodlands, Texas, États-Unis, 77384
        • Recrutement
        • Adverum site 231

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

INCLUSION CRITERIA:

  1. Male or female, aged ≥ 50 years at Screening Visit 1.
  2. Must agree to use an acceptable form of contraception.
  3. Have diagnosis of bilateral CNV secondary to nAMD.

  4. Meet ETDRS BCVA letter score criteria:

    • For Ixo-vec-experienced participants: Contralateral eye has an ETDRS BCVA letter score within a protocol-defined range appropriate for nAMD clinical trials.
    • For Ixo-vec-naïve participants: Both the initial eye and contralateral eye have ETDRS BCVA letter score within a protocol-defined range appropriate for nAMD clinical trials
  5. Have prior treatment history consistent with protocol-defined requirements, including prior anti-VEGF therapy and, where applicable, prior Ixo-vec exposure.
  6. Demonstrate a meaningful anatomic response to anti-VEGF in the contralateral eye (all participants) and in the initial eye (Ixo-vec-naïve participants only). Meaningful anatomic response to prior anti-VEGF therapy as defined in the protocol.
  7. Able to comply with study procedures according to the Investigator's judgment.

Other protocol-defined INCLUSION CRITERIA apply.

EXCLUSION CRITERIA:

A/ General Exclusion Criteria

  1. Have history of a medical condition (systemic disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) giving reasonable suspicion of a condition that contraindicates the use of Ixo-vec, compromises the participant's ability to comply with the planned study assessments, or that might affect the interpretation of the results of the study or render the participant at high risk for treatment complications in the opinion of the Investigator. History of severe coronavirus disease of 2019 (COVID-19) infection may meet this exclusion criterion if, in the opinion of the Investigator, it is likely to lead to any of the complications listed above.
  2. Received prior gene therapy (other than Ixo-vec, where applicable)
  3. Currently receiving steroids at Screening Visit 1 in the previously treated eye (Ixo-vec-experienced participants) or in either eye (Ixo-vec-naïve participants).
  4. Received any non-gene IMP or medical device in the contralateral eye (and/or initial eye for Ixo-vec-naïve participants) within 3 months of Screening Visit 1
  5. Have history of allergy, hypersensitivity, or contraindications to the use of any product or its excipients administered as part of this study.
  6. Have evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0%
  7. Have history or evidence of cardiovascular diseases and ongoing bleeding disorders as defined by the protocol.
  8. Use of systemic immunosuppressive therapy within a protocol-defined period.
  9. Received systemic anti-VEGF therapy within a protocol-defined period.

  10. Have history of malignancy within the 5 years prior to Screening Visit 1, except for adequately treated malignancies as defined by the protocol.

    B/Ocular Exclusion Criteria

  11. Have any active ocular or periocular infection in the contralateral eye in the contralateral eye (all participants) or in the initial eye (Ixo-vec-naïve participants only).
  12. Have any history or evidence of a concurrent intraocular condition in the contralateral eye (all participants) or in the initial eye (Ixo-vec-naïve participants only), including retinal diseases other than nAMD, that, in the judgment of the Investigator, could reduce the potential for visual improvement, confound assessment of the macula or require medical or surgical intervention during the study.
  13. Have prior ocular surgery or treatment that may confound assessment or increase risk.
  14. Have any history or evidence of retinal detachment (with or without repair) or retinal pigment epithelium rip/tear in the contralateral eye (all participants) or in the initial eye (Ixo-vec-naïve participants only), as determined by the Investigator.
  15. Have uncontrolled ocular hypertension or glaucoma as defined by the protocol.
  16. Have any history of inflammatory anterior chamber cell or vitreous cell ≥ 2+ in the initial eye, that, in the opinion of the Investigator and Sponsor, predisposes the contralateral eye to a heightened risk of intraocular inflammation. Enrollment of a participant with prior anterior chamber cell or vitreous cell ≥2+ in the initial eye requires discussion with the medical monitor.

Other protocol-defined EXCLUSION CRITERIA apply.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Ixo-vec dosing in Contralateral Eye
Population of Ixo-vec-Experienced or Ixo-vec Naïve Participants.
Génétique: Ixo-vec
Ixo-vec (6 × 10^10 vg/eye) will be administered intravitreally

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of ocular adverse events (AEs)
Délai: Baseline through Week 28
The number of participants who experience an ocular adverse event will be summarized.
Baseline through Week 28
Incidence of ocular serious adverse events (SAEs).
Délai: Baseline through Week 28
The number of participants who experience ocular serious adverse event will be summarized.
Baseline through Week 28
Incidence of non-ocular serious adverse events (SAEs).
Délai: Baseline through Week 28
The number of participants who experience non-ocular serious adverse event will be summarized.
Baseline through Week 28

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mean change from baseline in best corrected visual acuity (BCVA) over time through Week 28.
Délai: Baseline through Week 28
BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
Baseline through Week 28
Mean change from baseline in central subfield thickness (CST) over time through Week 28.
Délai: Baseline through Week 28
CST as measured by spectral domain optical coherence tomography (SD-OCT).
Baseline through Week 28
Mean number of supplemental aflibercept IVT injections received from Week 4 through Week 28
Délai: Week 4 through Week 28
Efficacy will be measured by the number of supplemental aflibercept injections post Ixo-vec administration.
Week 4 through Week 28
Percentage of participants who are supplemental aflibercept injection-free through Week 28.
Délai: Baseline through Week 28
Efficacy will be measured as the percentage of participants who will not received supplemental aflibercept injections post Ixo-vec administration.
Baseline through Week 28

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Adverum Biotechnologies, Inc.

Les enquêteurs

  • Directeur d'études: Adam Turpcu, PhD, Adverum Biotechnologies, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 juin 2026

Achèvement primaire (Estimé)

1 juin 2031

Achèvement de l'étude (Estimé)

1 juin 2031

Dates d'inscription aux études

Première soumission

2 juin 2026

Première soumission répondant aux critères de contrôle qualité

2 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ADVM-022-14

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Adverum is committed to transparency. Appropriately de-identified participant-level data and supporting documents may be shared under appropriate conditions (e.g. when contractually permitted and when participants provide appropriate consent). Individual patient-level data would only be shared following completion of this study (and any associated studies), completion of applicable regulatory submissions, and in accordance with applicable regulations and laws, as well as criteria established by Adverum, our collaborators and/or industry best practices. Shared datasets and/or documents may be de-identified and/or redacted to protect participant identity and to protect sensitive and confidential information. For inquiries, please contact us at datasharing@adverum.com

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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