Ixoberogene Soroparvovec (Ixo-vec) Contralateral Dosing Study in Participants With Neovascular Age-related Macular Degeneration
Eligible age
50+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Adverum Biotechnologies, Inc.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Phoenix
Bakersfield · Fullerton
Deerfield Beach · Fort Lauderdale · Jacksonville
‘Aiea
Lemont
Teaneck
West Columbia
The Woodlands
Source: ClinicalTrials.gov · NCT07630649 · last updated 2026-08-05