Diabetic Macular EdemaNCT05607810
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
An observational study of Diabetic Macular Edema and Diabetic Retinopathy, run by Adverum Biotechnologies, Inc. at 7 sites in 2 countries.
Trial summary
This is a prospective, observational study designed to evaluate the long-term safety and tolerability of ADVM-022 in participants with diabetic macular edema (DME). Participants who previously participated in the INFINITY parent study and received a single unilateral intravitreal dose of ADVM-022 are eligible for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Diabetic Retinopathy
- What is being tested?
- ADVM-022
- How many people
- 22 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 10 Aug 2022to Apr 2031
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who received ADVM-022 at any dose in the INFINITY study
Who may be able to join
- Must have participated in the ADVM-022-04 [INFINITY] (parent) study and received ADVM-022
- Must provide signed informed consent
- Must be willing and able to comply with all study procedures
Who cannot join
- None
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Adverum Clinical Site
Austin, Texas, 78705
Adverum Clinical Site
Bellaire, Texas, 77030
Adverum Clinical Site
Beverly Hills, California, 90211
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 Follow-Up Study of ADVM-022 in Diabetic Macular Edema- INFINITY Extension
This is a prospective, observational study designed to evaluate the long-term safety and tolerability of ADVM-022 in participants with diabetic macular edema (DME). Participants who previously participated in the INFINITY parent study and received a single unilateral intravitreal dose of ADVM-022 are eligible for enrollment upon completion of the end of study visit in the parent study.
Read the detailed description
This is a multi-center study to evaluate the long-term safety and tolerability of a single intravitreal (IVT) injection of ADVM-022 in a preceding "parent" study, ADVM-022-04 [INFINITY]. Participants will be followed for 8 years in this study for a total of 10 years post-ADVM-022 administration (inclusive of the parent study follow-up). There is no investigational treatment administered in this study.
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- Being tested
- ADVM-022
- Keywords
- ADVM-022, ADVM-022-04, ADVM-022-10, AAV.7m8, Anti-VEGF therapy, Blindness, INFINITY, Gene therapy, Aflibercept (Eylea), Retinal Diseases, Eye Diseases, AAV Vector, Adverum, DME, DR, INFINITY-EXT, INFINITY-Extension, Diabetic eye disease, Long-term Extension, Long-term Follow-up, AAV vector, Ixoberogene soroparvovec
- Medical subject headings
- Diabetic Retinopathy, Blindness, Retinal Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADVM-022Genetic
Also called AAV.7m8-aflibercept, Ixoberogene soroparvovec, Ixo-vec, LY5389922
Long term follow-up of subjects who previously received ADVM-022 (Ixo-vec)
| Study group | Role | What they receive |
|---|---|---|
| No Intervention - Subjects who received ADVM-022 (Ixo-vec) in prior clinical study | Not described Receives: Genetic: ADVM-022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ocular and non-ocular adverse events (AEs)
Measured: 168 Weeks
Severity of ocular and non-ocular AEs
Measured: 168 Weeks
Secondary outcomes (11)
Time to first worsening of DME disease activity through Year 10
Measured: Through Year 10
Mean change from Baseline in central subfield thickness (CST) and macular volume through Year 10 measured by SD-OCT
Measured: Through Year 10
Mean change from Baseline in BCVA through Year 10
Measured: Through Year 10
Percentage of participants with a 2-step or greater improvement in DRSS score from Baseline through Year 10
Measured: Through Year 10
Percentage of participants with a 2-step or greater worsening in DRSS score from Baseline through Year 10
Measured: Through Year 10
Mean annualized number of supplemental aflibercept (2mg IVT) injections from Baseline through Year 10
Measured: Through Year 10
Cumulative incidence of vision-threatening complications from Baseline through Year 10
Measured: Through Year 10
Incidence of CST < 300 μm over time through Year 10
Measured: Through Year 10
Incidence and severity of post-Baseline intraocular inflammation (IOI) (including anterior chamber cells and flare) as evaluated via slit lamp biomicroscopy through Year 10
Measured: Through Year 10
Incidence and severity of vitreous hemorrhage, anterior chamber cells, and vitreous haze via indirect ophthalmic examination through Year 10
Measured: Through Year 10
Incidence of new or worsening retinal vascular abnormalities evaluated via fluorescein angiography through Year 10
Measured: Through Year 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start10 Aug 2022
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adverum Biotechnologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Turpcu, Ph.D., Study director, Adverum Biotechnologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607810
- Sponsor's protocol ID
- ADVM-022-10
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Follow-Up Study of ADVM-022 in Diabetic Macular Edema- INFINITY Extension
- ClinicalTrials.gov ID
- NCT05607810
- Acronym / sponsor ID
- ADVM-022-10
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- Keywords
- ADVM-022, ADVM-022-04, ADVM-022-10, AAV.7m8, Anti-VEGF therapy, Blindness, INFINITY, Gene therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Adverum Biotechnologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 7 Nov 2022 (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.
This is a prospective, observational study designed to evaluate the long-term safety and tolerability of ADVM-022 in participants with diabetic macular edema (DME). Participants who previously participated in the INFINITY parent study and received a single unilateral intravitreal dose of ADVM-022 are eligible for enrollment upon completion of the end of study visit in the parent study.
Detailed description
This is a multi-center study to evaluate the long-term safety and tolerability of a single intravitreal (IVT) injection of ADVM-022 in a preceding "parent" study, ADVM-022-04 [INFINITY]. Participants will be followed for 8 years in this study for a total of 10 years post-ADVM-022 administration (inclusive of the parent study follow-up). There is no investigational treatment administered in this study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Intervention - Subjects who received ADVM-022 (Ixo-vec) in prior clinical study | – | Genetic: ADVM-022 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who received ADVM-022 at any dose in the INFINITY study
Key inclusion criteria (3 listed)
- Must have participated in the ADVM-022-04 [INFINITY] (parent) study and received ADVM-022
- Must provide signed informed consent
- Must be willing and able to comply with all study procedures
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-aflibercept, Ixoberogene soroparvovec, Ixo-vec, LY5389922Long term follow-up of subjects who previously received ADVM-022 (Ixo-vec) | Genetic | No Intervention - Subjects who received ADVM-022 (Ixo-vec) in prior clinical study |
Primary outcome
Incidence of ocular and non-ocular adverse events (AEs)
Time frame: 168 Weeks
Severity of ocular and non-ocular AEs
Time frame: 168 Weeks
11 secondary outcomes
Time to first worsening of DME disease activity through Year 10
Time frame: Through Year 10
Mean change from Baseline in central subfield thickness (CST) and macular volume through Year 10 measured by SD-OCT
Time frame: Through Year 10
Mean change from Baseline in BCVA through Year 10
Time frame: Through Year 10
Percentage of participants with a 2-step or greater improvement in DRSS score from Baseline through Year 10
Time frame: Through Year 10
Percentage of participants with a 2-step or greater worsening in DRSS score from Baseline through Year 10
Time frame: Through Year 10
Mean annualized number of supplemental aflibercept (2mg IVT) injections from Baseline through Year 10
Time frame: Through Year 10
Cumulative incidence of vision-threatening complications from Baseline through Year 10
Time frame: Through Year 10
Incidence of CST < 300 μm over time through Year 10
Time frame: Through Year 10
Incidence and severity of post-Baseline intraocular inflammation (IOI) (including anterior chamber cells and flare) as evaluated via slit lamp biomicroscopy through Year 10
Time frame: Through Year 10
Incidence and severity of vitreous hemorrhage, anterior chamber cells, and vitreous haze via indirect ophthalmic examination through Year 10
Time frame: Through Year 10
Incidence of new or worsening retinal vascular abnormalities evaluated via fluorescein angiography through Year 10
Time frame: Through Year 10
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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Adam Turpcu, Ph.D. study director
Adverum Biotechnologies, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema and Diabetic Retinopathy, run by Adverum Biotechnologies, Inc. at 7 sites in 2 countries.
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 3 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Puerto Rico. 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?
Incidence of ocular and non-ocular adverse events (AEs) (time frame: 168 Weeks). The study lists 2 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 27 Oct 2026.