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Active, Not Recruiting

NCT Number: NCT05607810

Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Macular Edema Blindness Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Diseases Sensation Disorders Signs and Symptoms Vascular Diseases Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Adverum Clinical Site, Arecibo, Puerto Rico

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About this 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 a total of 5 years post- ADVM-022 administration (inclusive of the parent study). There is no investigational treatment administered in this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • None

Treatment and study plan

ADVM-022

Genetic

Long term follow-up of subjects who previously received ADVM-022

Other names: AAV.7m8-aflibercept

Primary outcomes

  1. Incidence of ocular and non-ocular adverse events (AEs)

    Time frame: 168 Weeks

  2. Severity of ocular and non-ocular AEs

    Time frame: 168 Weeks

Secondary outcomes

  1. Time to worsening of DME disease activity

    Time frame: 168 Weeks

  2. Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT

    Time frame: 168 Weeks

  3. Change from Baseline in BCVA over time

    Time frame: 168 Weeks

  4. Incidence of 2-step and 3-step improvement in DRSS score over time

    Time frame: 168 Weeks

  5. Incidence of 2-step and 3-step worsening in DRSS score over time

    Time frame: 168 Weeks

  6. Frequency of supplemental aflibercept (2mg IVT) injections over time

    Time frame: 168 Weeks

  7. Occurrence of vision-threatening complications over time

    Time frame: 168 Weeks

  8. Incidence of CST < 300 μm over time

    Time frame: 168 Weeks

  9. Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation

    Time frame: 168 Weeks

Sponsors and collaborators

Lead sponsor

Adverum Biotechnologies, Inc.

Industry

Registry information

Official study title

A Long-Term Follow-Up Study of ADVM-022 in Diabetic Macular Edema- INFINITY Extension

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2022
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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