A Phase 2 interventional study of ADVM-022 and ADVM-022 in Neovascular Age-related Macular Degeneration, sponsored by Adverum Biotechnologies, Inc.. Active, not recruiting at 39 sites in 3 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Adverum Biotechnologies, Inc. · Phase 2, Interventional, and Treatment
Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process in nAMD is stimulated and modulated by vascular endothelial growth factor (VEGF). Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-16 weeks. ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.
This Phase 2, multi-center, randomized, double-masked, parallel group study is designed to evaluate the safety, tolerability, and efficacy of a single IVT injection of ADVM-022 at one of two doses (2 × 10\^11 vg/eye [2E11] or 6 × 10\^10 vg/eye [6E10]) accompanied by one of four prophylactic corticosteroid treatment regimens.
Anti-VEGF treatment-experienced study participants meeting the eligibility criteria that will be randomized between the 2E11 vg/eye and 6E10 vg/eye ADVM-022 doses each with 4 prophylaxis arms for a total of 8 treatment arms, and only one eye per study participant will be selected as the study eye.
Safety, tolerability, and efficacy will be evaluated for a period of approximately 5 years from baseline.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's enrollment of 69 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Adverum Biotechnologies, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single intravitreal injection of ADVM-022 2E11 vg/eye
Genetic: ADVM-022
A single intravitreal injection of ADVM-022 6E10 vg/eye
Genetic: ADVM-022
A single IVT injection of 2E11 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens
A single IVT injection of 6E10 vg/eye ADVM-022 dose in combination with one (1) of four (4) corticosteroid treatment regimens
Incidence of ocular and non-ocular adverse events
Incidence of ocular and non-ocular adverse events
Time frame: Up to Week 52
Severity of ocular and non-ocular adverse events
Severity of ocular and non-ocular adverse events
Time frame: Up to Week 52
Mean change in best corrected visual acuity (BCVA) from Baseline
BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS)
Time frame: Baseline up to Week 52
Percentage of participants from Baseline who lose/gain at least 5, 10 or 15 letters in BCVA
BCVA measured by ETDRS
Time frame: Baseline up to 5 years
Mean change in BCVA from Baseline
BCVA measured by ETDRS
Time frame: Baseline up to 5 years
Percentage of participants who are supplemental aflibercept injection-free
Supplemental anti-VEGF treatments required post therapy
Time frame: Baseline up to 5 years
Percent reduction in annualized anti-VEGF injections
Supplemental annualized anti-VEGF treatments required post therapy to the year prior
Time frame: Baseline up to 5 years
Mean change in Central Subfield Thickness (CST) from Baseline
To evaluate the effect of ADVM-022 on CST
Time frame: Baseline up to 5 years
Percentage of participants without CST fluctuations
To evaluate the effect of ADVM-022 on CST
Time frame: Baseline up to 5 years
Mean number of CST fluctuations from Baseline
To evaluate the effect of ADVM-022 on CST
Time frame: Baseline up to 5 years
Percentage of participants without post-prophylactic inflammation
To assess the long-term safety and tolerability of a single IVT injection of ADVM-022
Time frame: Baseline up to 5 years
Incidence of ocular and non-ocular adverse events
To assess the long-term safety and tolerability of a single IVT injection of ADVM-022
Time frame: Up to 60 months
Severity of ocular and non-ocular adverse events
To assess the long-term safety and tolerability of a single IVT injection of ADVM-022
Time frame: Up to 60 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Aug 2022 to primary completion in Aug 2024, 24 months.
Of 66 industry-sponsored phase 2 interventional studies under Macular Degeneration, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's 24 months is close to that.
Counting every sponsor, half of 83 studies reached it within 24 months; a quarter within 16 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Adverum Biotechnologies, Inc.