This study evaluated ADVM-022, a gene therapy injected into the eye (intravitreal), compared with the drug Aflibercept in patients with vision loss due to diabetic macular edema. Adults aged 18 and over with Type 1 or Type 2 diabetes were eligible. The study was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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