ADVM-022 Intravitreal Gene Therapy for DME

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Macular Edema, Diabetic Retinopathy

In brief

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

Key facts

Study ID

NCT04418427

Run by

Adverum Biotechnologies, Inc.

People needed

36

Starts

2020-05-28

Expected to finish

2023-06-14

Last updated by the study team

2025-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Adverum Clinical Site — Phoenix, Arizona, United States
• Adverum Clinical Site — Bakersfield, California, United States
• Adverum Clinical Site — Beverly Hills, California, United States
• Adverum Clinical Site — Golden, Colorado, United States
• Adverum Clinical Site — Deerfield Beach, Florida, United States
• Adverum Clinical Site — Reno, Nevada, United States
• Adverum Clinical Site — Philadelphia, Pennsylvania, United States
• Adverum Clinical Site — West Columbia, South Carolina, United States
• Adverum Clinical Site — Nashville, Tennessee, United States
• Adverum Clinical Site — Abilene, Texas, United States
• Adverum Clinical Site — Austin, Texas, United States
• Adverum Clinical Site — Houston, Texas, United States
• Adverum Clinical Site — The Woodlands, Texas, United States
• Adverum Clinical Site — Arecibo, Puerto Rico

Full record on ClinicalTrials.gov

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