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Clinical trial

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

ID
Name
ADVM-022-10
Description
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.
Trial arms
Trial start
2022-08-10
Estimated PCD
2026-03-01
Trial end
2026-03-01
Treatment
ADVM-022
Long term follow-up of subjects who previously received ADVM-022
Arms:
No Intervention - Subjects who received ADVM-022 in prior clinical study
Other names:
AAV.7m8-aflibercept
Size
22
Primary endpoint
Incidence of ocular and non-ocular adverse events (AEs)
168 Weeks
Severity of ocular and non-ocular AEs
168 Weeks
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 22, 'type': 'ESTIMATED'}}
Updated at
2022-11-07

1 organization

1 product

2 indications

Product
ADVM-022
Indication
Diabetic Macular Edema
Indication
Diabetic Retinopathy
Organization
Adverum Biotechnologies