Neovascular Age-Related Macular Degeneration (nAMD) Wet AMDPhase 2NCT07630649
Ixoberogene Soroparvovec (Ixo-vec) Contralateral Dosing Study in Participants With Neovascular Age-related Macular Degeneration
A Phase 2 study testing Ixo-vec in people with Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD, run by Adverum Biotechnologies, Inc. at 12 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD
- What is being tested?
- Ixo-vec
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 12 sitesUnited States
- Study dates
- 2 Jun 2026to Jun 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥ 50 years at Screening Visit 1.
- Must agree to use an acceptable form of contraception.
- Have diagnosis of bilateral CNV secondary to nAMD.
- 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
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- Have prior treatment history consistent with protocol-defined requirements, including prior anti-VEGF therapy and, where applicable, prior Ixo-vec exposure.
- 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.
- Able to comply with study procedures according to the Investigator's judgment.
- Other protocol-defined INCLUSION CRITERIA apply.
Who cannot join
- A/ General Exclusion Criteria
- 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.
- Received prior gene therapy (other than Ixo-vec, where applicable)
- Currently receiving steroids at Screening Visit 1 in the previously treated eye (Ixo-vec-experienced participants) or in either eye (Ixo-vec-naïve participants).
- 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
- Have history of allergy, hypersensitivity, or contraindications to the use of any product or its excipients administered as part of this study.
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- Have evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0%
- Have history or evidence of cardiovascular diseases and ongoing bleeding disorders as defined by the protocol.
- Use of systemic immunosuppressive therapy within a protocol-defined period.
- Received systemic anti-VEGF therapy within a protocol-defined period.
- 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
- 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).
- 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.
- Have prior ocular surgery or treatment that may confound assessment or increase risk.
- 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.
- Have uncontrolled ocular hypertension or glaucoma as defined by the protocol.
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Adverum site 149
‘Aiea, Hawaii, 96701
- Recruiting
Adverum site 109
Bakersfield, California, 93309
- Recruiting
Adverum site 124
Deerfield Beach, Florida, 33064
- Recruiting
Adverum site 176
Fort Lauderdale, Florida, 33308
- Recruiting
Adverum site 169
Fullerton, California, 92835
- Recruiting
Adverum site 168
Jacksonville, Florida, 32216
- Recruiting
Adverum site 179
Lemont, Illinois, 60439
- Recruiting
Adverum site 126
Phoenix, Arizona, 85053
- Recruiting
Adverum site 171
Teaneck, New Jersey, 07666
- Recruiting
Adverum site 107
The Woodlands, Texas, 77384
- Recruiting
Adverum site 231
The Woodlands, Texas, 77384
- Recruiting
Adverum site 122
West Columbia, South Carolina, 29169
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Ixo-vec
- Keywords
- macular degeneration, AMD, neovascular macular degeneration, gene therapy, contralateral, Ixoberogene soroparvovec, Ixo-vec, Aflibercept, Neovascular age-related macular degeneration, nAMD, wAMD, ADVM, ADVM-022, wet AMD, Wet Age-related Macular Degeneration, CNV, Neovascular AMD, AAV, AAV vector, AAV.7m8-aflibercept
- Medical subject headings
- Macular Degeneration, Eye Diseases, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixo-vecGenetic
Ixo-vec (6 × 10^10 vg/eye) will be administered intravitreally
| Study group | Role | What they receive |
|---|---|---|
| Ixo-vec dosing in Contralateral Eye | Experimental | Population of Ixo-vec-Experienced or Ixo-vec Naïve Participants. Receives: Genetic: Ixo-vec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ocular adverse events (AEs)
The number of participants who experience an ocular adverse event will be summarized.
Measured: Baseline through Week 28
Incidence of ocular serious adverse events (SAEs).
The number of participants who experience ocular serious adverse event will be summarized.
Measured: Baseline through Week 28
Incidence of non-ocular serious adverse events (SAEs).
The number of participants who experience non-ocular serious adverse event will be summarized.
Measured: Baseline through Week 28
Secondary outcomes (4)
Mean change from baseline in best corrected visual acuity (BCVA) over time through Week 28.
BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
Measured: Baseline through Week 28
Mean change from baseline in central subfield thickness (CST) over time through Week 28.
CST as measured by spectral domain optical coherence tomography (SD-OCT).
Measured: Baseline through Week 28
Mean number of supplemental aflibercept IVT injections received from Week 4 through Week 28
Efficacy will be measured by the number of supplemental aflibercept injections post Ixo-vec administration.
Measured: Week 4 through Week 28
Percentage of participants who are supplemental aflibercept injection-free through Week 28.
Efficacy will be measured as the percentage of participants who will not received supplemental aflibercept injections post Ixo-vec administration.
Measured: Baseline through Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start2 Jun 2026
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular Degeneration (nAMD) Wet AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants previously treated in one eye (initial eye) and/or treatment-naive participants will receive sequential bilateral administration, with dosing in the contralateral eye.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adverum Biotechnologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Turpcu, PhD, Study director, Adverum Biotechnologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630649
- Sponsor's protocol ID
- ADVM-022-14
- Status last verified
- Aug 2026
- First submitted
- 2 Jun 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07630649
- Acronym / sponsor ID
- ADVM-022-14
- Keywords
- macular degeneration, AMD, neovascular macular degeneration, gene therapy, contralateral, Ixoberogene soroparvovec, Ixo-vec, Aflibercept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Adverum Biotechnologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants previously treated in one eye (initial eye) and/or treatment-naive participants will receive sequential bilateral administration, with dosing in the contralateral eye.
| Arm | Type | Receives |
|---|---|---|
| Ixo-vec dosing in Contralateral Eye | Experimental | Genetic: Ixo-vecPopulation of Ixo-vec-Experienced or Ixo-vec Naïve Participants. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, aged ≥ 50 years at Screening Visit 1.
- Must agree to use an acceptable form of contraception.
- Have diagnosis of bilateral CNV secondary to nAMD.
- Meet ETDRS BCVA letter score criteria:
- Have prior treatment history consistent with protocol-defined requirements, including prior anti-VEGF therapy and, where applicable, prior Ixo-vec exposure.
Key exclusion criteria (19 listed)
- A/ General Exclusion Criteria
- 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.
- Received prior gene therapy (other than Ixo-vec, where applicable)
- Currently receiving steroids at Screening Visit 1 in the previously treated eye (Ixo-vec-experienced participants) or in either eye (Ixo-vec-naïve participants).
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ixo-vecIxo-vec (6 × 10^10 vg/eye) will be administered intravitreally | Genetic | Ixo-vec dosing in Contralateral Eye |
Primary outcome
Incidence of ocular adverse events (AEs)
Time frame: Baseline through Week 28
The number of participants who experience an ocular adverse event will be summarized.
Incidence of ocular serious adverse events (SAEs).
Time frame: Baseline through Week 28
The number of participants who experience ocular serious adverse event will be summarized.
Incidence of non-ocular serious adverse events (SAEs).
Time frame: Baseline through Week 28
The number of participants who experience non-ocular serious adverse event will be summarized.
4 secondary outcomes
Mean change from baseline in best corrected visual acuity (BCVA) over time through Week 28.
Time frame: Baseline through Week 28
Mean change from baseline in central subfield thickness (CST) over time through Week 28.
Time frame: Baseline through Week 28
Mean number of supplemental aflibercept IVT injections received from Week 4 through Week 28
Time frame: Week 4 through Week 28
Percentage of participants who are supplemental aflibercept injection-free through Week 28.
Time frame: Baseline through Week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Turpcu, PhD study director
Adverum Biotechnologies, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixo-vec in people with Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD, run by Adverum Biotechnologies, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adverum Study Contact (650-656-9323, ADVM02214ClinOp@adverum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ocular adverse events (AEs) (time frame: Baseline through Week 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.