A Phase 2, Multi-Center, Randomized, Double-Masked, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects With Diabetic Macular Edema [INFINITY]

ADVM-022-04

A Phase 2, Multi-Center, Randomized, Double-Masked\*, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema \[INFINITY\] \*sponsor unmasked for enhanced safety monitoring as of May 2021

2020-05-28

2022-11-22

2022-11-22

Completed

Early phase I

36

Inclusion Criteria: * Age ≥ 18 * Type 1 or Type 2 diabetes mellitus * Willing and able to provide informed consent * Vision impairment due to center involving diabetic macular edema Exclusion Criteria: * Uncontrolled diabetes defined as HbA1C \>10%, or history of diabetic ketoacidosis within 3 months prior to randomization; or subjects who, within the last 3 months, initiated intensive insulin treatment (a pump or multiple daily injection) or plan to do so in the next 3 months. * Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months * Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg * Known severe renal impairment * High risk Proliferative Diabetic Retinopathy * History of retinal disease in the study eye other than diabetic retinopathy * History of retinal detachment (with or without repair) in the study eye * History of vitrectomy, trabeculectomy, or other filtration surgery in the study eye * Any prior focal or grid laser photocoagulation or any prior PRP in the study eye * Current or planned pregnancy or breastfeeding

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "From May 2020 through April 2021: Double-masked study Subjects, outcomes assessors and the designated masked study personnel will be masked to subject's treatment assignment throughout the study. There must be a minimum of two physicians per site to fulfill the masking requirements of the study. A masked and unmasked investigator are required to be present for administration of the preceding dose of aflibercept or sham and following dose of ADVM-022 or sham visits, thereafter only the masked investigator is required to be present.\n\nStarting May 2021: Open label study, study was unmasked for enhance safety monitoring."}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}

2023-08-08