Wet Age-related Macular DegenerationNCT04645212
Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]
An observational study of Wet Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, run by Adverum Biotechnologies, Inc. at 9 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration
- What is being tested?
- ADVM-022
- How many people
- 23 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 Dec 2020to 26 Jun 2030
- Phase
- Observational
- 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
Study population: * Participants who received ADVM-022 at any dose in the OPTIC study * Up to 30 participants from all cohorts of OPTIC
Who may be able to join
- Participants who received a single dose of ADVM-022 at any dose in the OPTIC study
- Willing and able to provide informed consent
Who cannot join
- None
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Adverum Clinical Site
Bakersfield, California, 93309
Adverum Clinical Site
Bellaire, Texas, 77401
Adverum Clinical Site
Beverly Hills, California, 90211
Adverum Clinical Site
Deerfield Beach, Florida, 33064
Adverum Clinical Site
Lakewood, Colorado, 80228
Adverum Clinical Site
Nashville, Tennessee, 37203
Adverum Clinical Site
Philadelphia, Pennsylvania, 19107
Adverum Clinical Site
Reno, Nevada, 89502
Adverum Clinical Site
The Woodlands, Texas, 77384
About this study
Official title: A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension
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).
Read the detailed description
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.
- Being tested
- ADVM-022
- Keywords
- Choroidal Neovascularization, ADVM-022, OPTIC Study, CNV, ADVM-022-01, ADVM-022-07, AAV.7m8, Anti-VEGF therapy, Blindness, Gene therapy, Aflibercept (Eylea), Age-Related Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, AAV Vector, Adverum, wAMD, AMD
- Medical subject headings
- Choroidal Neovascularization, Blindness, Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADVM-022Biological
Also called AAV.7m8-aflibercept
Long term follow-up of subjects that received ADVM-022
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants with wet AMD who received any dose of ADVM-022 in a prior clinical study. Receives: Biological: ADVM-022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and incidence of ocular and systemic adverse events (AEs).
Severity and incidence of ocular and systemic adverse events
Measured: 416 weeks (8 years)
Secondary outcomes (12)
Mean change in best corrected visual acuity (BCVA) from baseline, over time
Mean change in best corrected visual acuity (BCVA) from baseline, over time
Measured: 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
Measured: 416 weeks (8 years)
Mean number of supplemental aflibercept injections over time
Mean number of supplemental aflibercept injections over time
Measured: 416 weeks (8 years)
Percentage of participants requiring supplemental bolus aflibercept over time
Percentage of participants requiring supplemental bolus aflibercept over time
Measured: 416 weeks (8 years)
Time to first supplemental aflibercept requirement
Time to first supplemental aflibercept requirement
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 416 weeks (8 years)
Percentage of participants with CST fluctuations > 50 μm over time
Percentage of participants with CST fluctuations > 50 μm over time
Measured: 416 weeks (8 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start14 Dec 2020
- Primary completion26 Jun 2030 (estimated)
- Study completion26 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular DegenerationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adverum Biotechnologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- OPTIC-EXT Medical Monitor, Study director, Adverum Biotechnologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645212
- Sponsor's protocol ID
- ADVM-022-07
- Status last verified
- Feb 2026
- First submitted
- 20 Nov 2020
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension
- ClinicalTrials.gov ID
- NCT04645212
- Acronym / sponsor ID
- ADVM-022-07
- Keywords
- Choroidal Neovascularization, ADVM-022, OPTIC Study, CNV, ADVM-022-01, ADVM-022-07, AAV.7m8, Anti-VEGF therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Adverum Biotechnologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 26 Jun 2030 (estimated)
- Study completion
- 26 Jun 2030 (estimated)
- First posted
- 27 Nov 2020 (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.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Biological: ADVM-022Participants with wet AMD who received any dose of ADVM-022 in a prior clinical study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Participants who received ADVM-022 at any dose in the OPTIC study * Up to 30 participants from all cohorts of OPTIC
Key inclusion criteria (2 listed)
- Participants who received a single dose of ADVM-022 at any dose in the OPTIC study
- Willing and able to provide informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ADVM-022Also: AAV.7m8-afliberceptLong term follow-up of subjects that received ADVM-022 | Biological | 1 |
Primary outcome
Severity and incidence of ocular and systemic adverse events (AEs).
Time frame: 416 weeks (8 years)
Severity and incidence of ocular and systemic adverse events
12 secondary outcomes
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
Time frame: 416 weeks (8 years)
Mean number of supplemental aflibercept injections over time
Time frame: 416 weeks (8 years)
Percentage of participants requiring supplemental bolus aflibercept over time
Time frame: 416 weeks (8 years)
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
Time frame: 416 weeks (8 years)
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 frame: 416 weeks (8 years)
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)
Time frame: 416 weeks (8 years)
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
Time frame: 416 weeks (8 years)
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 10 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Wet Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
Wet Age-related Macular Degeneration
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
RecruitingPhase 1
Safety and Efficacy Study of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).
nAMD
RecruitingPhase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration
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. This study is not recruiting at the moment.
OPTIC-EXT Medical Monitor study director
Adverum Biotechnologies, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wet Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, run by Adverum Biotechnologies, Inc. at 9 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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity and incidence of ocular and systemic adverse events (AEs). (time frame: 416 weeks (8 years)). 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 10 Feb 2026.