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RecruitingNCT07489131ALVOEYE-HDUpdated Apr 30, 2026

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

A Phase 3 interventional study of AVT29 (proposed aflibercept HD biosimilar) and Eylea HD (aflibercept HD) in Diabetic Macular Edema, sponsored by Alvotech Swiss AG. Recruiting at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Alvotech Swiss AG · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Macular Edema
03

In context

Lead sponsor

Alvotech Swiss AG is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
256 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: AVT29 (proposed aflibercept HD biosimilar)

  • Active comparator
    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.

    Drug: Eylea HD (aflibercept HD)

Interventions

  • DrugAVT29 (proposed aflibercept HD biosimilar)

    Patients will receive IVT injections of AVT29

  • DrugEylea HD (aflibercept HD)

    Patients will receive IVT injections of Eylea HD

06

What researchers measure

Primary outcomes

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

    Time frame: week 8

07

Study locations

1 of 1 sites recruiting
  • Site 3004
    Budapest, Hungary
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07489131
Lead sponsor
Alvotech Swiss AG
Responsible party
Sponsor
First posted
Mar 23, 2026
Start date
Apr 22, 2026
Primary completion
Jul 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
Apr 30, 2026

Study contacts

Silvia Cirillo
Contact
alvotech.clinical@alvotech.com
+41 78 659 89 89

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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