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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05607810
• Other study ID #: ADVM-022-10
• Status: Enrolling by invitation
• Start date: August 10, 2022
• Est. completion date: March 2026

Study information

• Verified date: October 2022
• Source: Adverum Biotechnologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 enrollment upon completion of the end of study visit in the parent study.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 22
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Macular Edema

Intervention

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

Locations

Country	Name	City	State
Puerto Rico	Adverum Clinical Site	Arecibo
United States	Adverum Clinical Site	Austin	Texas
United States	Adverum Clinical Site	Bellaire	Texas
United States	Adverum Clinical Site	Beverly Hills	California
United States	Adverum Clinical Site	Philadelphia	Pennsylvania
United States	Adverum Clinical Site	Reno	Nevada
United States	Adverum Clinical Site	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Adverum Biotechnologies, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ocular and non-ocular adverse events (AEs)		168 Weeks
Primary	Severity of ocular and non-ocular AEs		168 Weeks
Secondary	Time to worsening of DME disease activity		168 Weeks
Secondary	Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT		168 Weeks
Secondary	Change from Baseline in BCVA over time		168 Weeks
Secondary	Incidence of 2-step and 3-step improvement in DRSS score over time		168 Weeks
Secondary	Incidence of 2-step and 3-step worsening in DRSS score over time		168 Weeks
Secondary	Frequency of supplemental aflibercept (2mg IVT) injections over time		168 Weeks
Secondary	Occurrence of vision-threatening complications over time		168 Weeks
Secondary	Incidence of CST < 300 µm over time		168 Weeks
Secondary	Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation		168 Weeks