Gene therapy shot aims to tame wet AMD in both eyes
NCT ID NCT07630649
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This study tests a gene therapy called Ixo-vec in the second eye of people with wet age-related macular degeneration (AMD) in both eyes. Fifteen adults aged 50 and older will receive a single injection in the second eye and be followed for about 5 years. The goal is to see if the treatment is safe and can reduce the need for regular eye injections to control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ixoberogene soroparvovec (Ixo-vec) gene therapy
- What this could lead to
- If successful, this could show that a single injection of gene therapy in each eye can reduce the need for frequent anti-VEGF injections to control wet AMD.
- What could go wrong
- This is a small, early-phase study with only 15 participants. Gene therapy carries risks like inflammation or vision changes, and it may not work as well in the second eye or last long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Adverum site 107
RECRUITINGThe Woodlands, Texas, 77384, United States
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Adverum site 109
RECRUITINGBakersfield, California, 93309, United States
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Adverum site 122
RECRUITINGWest Columbia, South Carolina, 29169, United States
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Adverum site 124
RECRUITINGDeerfield Beach, Florida, 33064, United States
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Adverum site 126
RECRUITINGPhoenix, Arizona, 85053, United States
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Adverum site 149
RECRUITING‘Aiea, Hawaii, 96701, United States
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Adverum site 168
RECRUITINGJacksonville, Florida, 32216, United States
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Adverum site 169
RECRUITINGFullerton, California, 92835, United States
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Adverum site 171
RECRUITINGTeaneck, New Jersey, 07666, United States
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Adverum site 176
RECRUITINGFort Lauderdale, Florida, 33308, United States
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Adverum site 179
RECRUITINGLemont, Illinois, 60439, United States
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Adverum site 231
RECRUITINGThe Woodlands, Texas, 77384, United States
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