An observational study in Wet Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, sponsored by Adverum Biotechnologies, Inc.. Active, not recruiting at 9 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Adverum Biotechnologies, Inc. · Observational
ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in participants with neovascular, or exudative (wet), age-related macular degeneration (nAMD).
ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is a serious condition and the leading cause of blindness in the elderly. The available therapies for treating wet AMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat wet AMD by providing durable expression of therapeutic levels of intraocular anti-VEGF protein (aflibercept) and maintaining the vision of patients. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet AMD receiving anti-VEGF therapy in clinical practice.
ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product in participants with neovascular or exudative (wet), age-related macular degeneration (nAMD) previously treated in the OPTIC parent study (Clinical Protocol No. ADVM-022-01 [OPTIC] - NCT03748784). There is no investigational treatment administered in this study.
In Part 1 of the OPTIC-EXT study participants will roll over from the OPTIC parent study and will be followed for 3 additional years (following 2-years of assessment period in the OPTIC parent study). In Part 2 of the OPTIC-EXT study consenting participants will have 5 annual in-clinic assessments for an additional 5 years of long-term follow-up following the completion of OPTIC-EXT (Part 1). As such participants who complete the parent study as well as Part 1 and Part 2 of the OPTIC-EXT study will have had 10 years of total long-term follow-up.
214 studies on the registry are indexed under Choroidal Neovascularization; 12 are open to participants now.
This study's enrollment of 23 is below the median of 79 across 42 observational studies indexed under Choroidal Neovascularization.
Browse Choroidal Neovascularization studies →Adverum Biotechnologies, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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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.
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.
Participants with wet AMD who received any dose of ADVM-022 in a prior clinical study.
Biological: ADVM-022
Long term follow-up of subjects that received ADVM-022
Also known as: AAV.7m8-aflibercept
Severity and incidence of ocular and systemic adverse events (AEs).
Severity and incidence of ocular and systemic adverse events
Time frame: 416 weeks (8 years)
Mean change in best corrected visual acuity (BCVA) from baseline, over time
Mean change in best corrected visual acuity (BCVA) from baseline, over time
Time frame: 416 weeks (8 years)
Mean change in central subfield thickness (CST) and macular volume from baseline, over time
Mean change in central subfield thickness (CST) and macular volume from baseline, over time
Time frame: 416 weeks (8 years)
Mean number of supplemental aflibercept injections over time
Mean number of supplemental aflibercept injections over time
Time frame: 416 weeks (8 years)
Percentage of participants requiring supplemental bolus aflibercept over time
Percentage of participants requiring supplemental bolus aflibercept over time
Time frame: 416 weeks (8 years)
Time to first supplemental aflibercept requirement
Time to first supplemental aflibercept requirement
Time frame: 416 weeks (8 years)
Percentage of participants without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time
Percentage of participants without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time
Time frame: 416 weeks (8 years)
Percentage of participants without subretinal fluid (SRF) by SD-OCT over time
Percentage of participants without subretinal fluid (SRF) by SD-OCT over time
Time frame: 416 weeks (8 years)
Time to first dry retina (defined as no IRF or SRF by SD-OCT)
Time to first dry retina (defined as no IRF or SRF by SD-OCT)
Time frame: 416 weeks (8 years)
Duration of fluid free status (defined as no IRF or SRF by SD-OCT)
Duration of fluid free status (defined as no IRF or SRF by SD-OCT)
Time frame: 416 weeks (8 years)
Percentage of participants developing geographic atrophy over time (as assessed by multiple imaging modalities)
Percentage of participants developing geographic atrophy over time (as assessed by multiple imaging modalities)
Time frame: 416 weeks (8 years)
Growth of geographic atrophy over time, as assessed by multiple imaging modalities
Growth of geographic atrophy over time, as assessed by multiple imaging modalities
Time frame: 416 weeks (8 years)
Percentage of participants with CST fluctuations > 50 μm over time
Percentage of participants with CST fluctuations \> 50 μm over time
Time frame: 416 weeks (8 years)
Plan to share: No
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Started Dec 2020 (actual). Primary completion is estimated for Jun 2030, 114 months after the start.
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This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Choroidal Neovascularization →
Adverum Biotechnologies, Inc.