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

2026년 8월 4일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

15

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Ixo-vec dosing in Contralateral Eye
Population of Ixo-vec-Experienced or Ixo-vec Naïve Participants.
유전적: Ixo-vec
Ixo-vec (6 × 10^10 vg/eye) will be administered intravitreally

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of ocular adverse events (AEs)
기간: 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).
기간: 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).
기간: Baseline through Week 28
The number of participants who experience non-ocular serious adverse event will be summarized.
Baseline through Week 28

2차 결과 측정

결과 측정
측정값 설명
기간
Mean change from baseline in best corrected visual acuity (BCVA) over time through Week 28.
기간: 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.
기간: 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
기간: 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.
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Adverum Biotechnologies, Inc.

수사관

  • 연구 책임자: Adam Turpcu, PhD, Adverum Biotechnologies, Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 2일

기본 완료 (추정된)

2031년 6월 1일

연구 완료 (추정된)

2031년 6월 1일

연구 등록 날짜

최초 제출

2026년 6월 2일

QC 기준을 충족하는 최초 제출

2026년 6월 2일

처음 게시됨 (실제)

2026년 6월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 4일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ADVM-022-14

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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