Status:
COMPLETED
ADVM-022 Intravitreal Gene Therapy for DME
Lead Sponsor:
Adverum Biotechnologies, Inc.
Conditions:
Diabetic Macular Edema
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Phase 2, Multi-Center, Randomized, Double-Masked\*, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema \[INFINITY\]
Detailed Description
ADVM-022 (also known as Ixo-vec and AAV.7m8-aflibercept) is an investigational gene therapy product developed for the treatment of serious retinal vascular diseases including Diabetic Macular Edema (D...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04418427
Start Date
May 28 2020
End Date
June 14 2023
Last Update
July 10 2025
Active Locations (14)
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1
Adverum Clinical Site
Phoenix, Arizona, United States, 85014
2
Adverum Clinical Site
Bakersfield, California, United States, 93309
3
Adverum Clinical Site
Beverly Hills, California, United States, 90211
4
Adverum Clinical Site
Golden, Colorado, United States, 80401