An observational study in Diabetic Macular Edema and Diabetic Retinopathy, sponsored by Adverum Biotechnologies, Inc.. Active, not recruiting at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Adverum Biotechnologies, Inc. · Observational
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.
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.
778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.
This study's planned enrollment of 22 is below the median of 172 across 263 observational studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →Adverum Biotechnologies, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who received ADVM-022 at any dose in the INFINITY study
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:
- None
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.
Genetic: ADVM-022
Long term follow-up of subjects who previously received ADVM-022 (Ixo-vec)
Also known as: AAV.7m8-aflibercept, Ixoberogene soroparvovec, Ixo-vec, LY5389922
Incidence of ocular and non-ocular adverse events (AEs)
Time frame: 168 Weeks
Severity of ocular and non-ocular AEs
Time frame: 168 Weeks
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
Plan to share: Undecided
No publications or documents are linked to this record.
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 Oct 2026. You cannot join it, but the record below documents what was studied.
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Adverum Biotechnologies, Inc.