Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema

NCT07489131 | Recruiting Phase 3

• 1 other identifier: AVT29-GL-C01
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Change from baseline to Week 8 in BCVA as measured by ETDRS letter score

  week 8

Study Arms (2)

AVT29 (proposed aflibercept HD biosimilar)

EXPERIMENTAL

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.

Drug: AVT29 (proposed aflibercept HD biosimilar)

Eylea HD (aflibercept HD)

ACTIVE COMPARATOR

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.

Drug: Eylea HD (aflibercept HD)

Interventions

AVT29 (proposed aflibercept HD biosimilar) DRUG

Patients will receive IVT injections of AVT29

AVT29 (proposed aflibercept HD biosimilar)

Eylea HD (aflibercept HD) DRUG

Patients will receive IVT injections of Eylea HD

Eylea HD (aflibercept HD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alvotech Swiss AG: lead

Study Sites (1)

Site 3004

Budapest, Hungary

RECRUITING

Central Study Contacts

Silvia Cirillo

CONTACT

+41 78 659 89 89; alvotech.clinical@alvotech.com

Riken Soni

CONTACT

alvotech.clinical@alvotech.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 23, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

HU (1)