Phase 2
N=36
ADVM-022 Intravitreal Gene Therapy for DME
Diabetic Macular Edema · Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT04418427 ↗Enrolled (actual)
36
Serious AEs
61.8%
Results posted
Jul 2025
Primary outcome: Primary: Time to Worsening of DME Disease Activity in the Study Eye. — 82.1; 96.1; 19.1 Weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 6E11 vg/eye of ADVM-022 (Biological); 2E11 vg/eye of ADVM-022 (Biological); Aflibercept (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Adverum Biotechnologies, Inc.
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Worsening of DME Disease Activity in the Study Eye. |
82.1; 96.1; 19.1 | — |
| SECONDARY Incidence of Ocular Adverse Events (AEs) |
12; 13; 9 | — |
| SECONDARY Incidence of Non-ocular Adverse Events (AEs) |
9; 9; 7 | — |
| SECONDARY Change From Baseline Central Subfield Thickness (CST) in Study Eye |
-84.4; -129.7; -129.7 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Over Time in the Study Eye |
-11.9; 10.1; 17.1 | — |
| SECONDARY Frequency of Supplemental Aflibercept Injections (2 mg IVT) in the Study Eye Over Time During the Study |
1.001; 0.423; 5.54 | — |
| SECONDARY Incidence of 2-step Improvement in Diabetic Retinopathy Severity Score (DRSS) in the Study Eye Over Time |
8; 8; 4 | — |
| SECONDARY Incidence of 3-step Improvement in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time |
3; 4; 0 | — |
| SECONDARY Incidence of 2-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time |
2; 0; 2 | — |
| SECONDARY Incidence of 3-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time |
1; 0; 1 | — |
| SECONDARY Occurrence of Any Vision Threatening Complications in the Study Eye (Anterior Segment Neovascularization, Vitreous Hemorrhage, or Any Other High-risk Proliferative DR, or Tractional Retinal Detachment) Over Time Through Week 96 |
2; 0; 1 | — |
| SECONDARY Incidence of CST <300 μm Over Time Through Week 96 in the Study Eye |
8; 6; 4 | — |
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]
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04418427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.