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

4 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

15

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Ixo-vec dosing in Contralateral Eye
Population of Ixo-vec-Experienced or Ixo-vec Naïve Participants.
Genetisch: Ixo-vec
Ixo-vec (6 × 10^10 vg/eye) will be administered intravitreally

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of ocular adverse events (AEs)
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: Baseline through Week 28
The number of participants who experience non-ocular serious adverse event will be summarized.
Baseline through Week 28

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean change from baseline in best corrected visual acuity (BCVA) over time through Week 28.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Adverum Biotechnologies, Inc.

Onderzoekers

  • Studie directeur: Adam Turpcu, PhD, Adverum Biotechnologies, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 juni 2026

Primaire voltooiing (Geschat)

1 juni 2031

Studie voltooiing (Geschat)

1 juni 2031

Studieregistratiedata

Eerst ingediend

2 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

4 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ADVM-022-14

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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