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

Alvotech

Status and phase: Enrolling; Phase 3

Conditions: Diabetic Macular Edema

Treatments: Drug: AVT29 (proposed aflibercept HD biosimilar); Drug: Eylea HD (aflibercept HD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07489131

AVT29-GL-C01

Details and patient eligibility

About

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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Main 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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256 participants in 2 patient groups

AVT29 (proposed aflibercept HD biosimilar)

Experimental group

Description:

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.

Treatment:

Drug: AVT29 (proposed aflibercept HD biosimilar)

Eylea HD (aflibercept HD)

Active Comparator group

Description:

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.

Treatment:

Drug: Eylea HD (aflibercept HD)