Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07489131

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

Led by Alvotech Swiss AG · Updated on 2026-04-30

256

Participants Needed

1

Research Sites

88 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is 18 years old or older at the time of signing the informed consent form
  • Participant is willing and able to comply with all study procedures and likely to complete the study
  • Participant has a diagnosis of diabetic macular edema secondary to diabetes mellitus with central involvement in the study eye
  • Participant has a best-corrected visual acuity ETDRS letter score between 73 and 34 letters inclusive (20/40 to 20/200 Snellen equivalent) in the study eye at screening and on Day 1 prior to randomization
  • Participant's vision decrease is primarily due to diabetic macular edema in the study eye
Not Eligible

You will not qualify if you...

  • Previous treatment with anti-VEGF therapy
  • History or concurrent disease other than diabetic macular edema that could compromise visual acuity
  • Any condition that may interfere with full participation in the study or pose significant risk, as judged by the investigator
  • Participants judged unsuitable for participation due to medical, psychiatric conditions, or potential noncompliance by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Site 3004

Budapest, Hungary

Actively Recruiting

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Research Team

S

Silvia Cirillo

CONTACT

R

Riken Soni

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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