A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared With Eylea HD in Participants With Diabetic Macular Edema
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Alvotech Swiss AG
- Enrollment
- 256
- Locations
- 1
- Primary Endpoint
- Change from baseline to Week 8 in BCVA as measured by ETDRS letter score
Study Overview
Brief Summary
This is a Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea HD in Participants with Diabetic Macular Edema.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Main Inclusion Criteria:
- •Participant is ≥18 years old at the time of signing the ICF.
- •Participant is willing and able to comply with all study procedures and likely to complete the study, based on the investigator's judgment.
- •Participant has a diagnosis of DME secondary to DM with central involvement in the study eye.
- •Participant has a BCVA ETDRS letter score of 73 to 34 letters inclusive (20/40 to 20/200 Snellen equivalent) in the study eye at screening and on Day 1 prior randomization.
- •Participant's decrease in vision is determined to be primarily the result of DME in the study eye.
Exclusion Criteria
- •previous treatment with anti-VEGF therapy
- •history or concurrent disease other than DME that could compromise visual acuity
- •Any condition that, in the Investigator ́s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data
- •participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.
Arms & Interventions
AVT29 (proposed aflibercept HD biosimilar)
Participants will receive 1 IVT injection of AVT29 at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion.
Intervention: AVT29 (proposed aflibercept HD biosimilar) (Drug)
Eylea HD (aflibercept HD)
Participants will receive 1 IVT injection of Eylea HD at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion.
Intervention: Eylea HD (aflibercept HD) (Drug)
Outcomes
Primary Outcomes
Change from baseline to Week 8 in BCVA as measured by ETDRS letter score
Time Frame: week 8
Secondary Outcomes
No secondary outcomes reported