Comparing AVT29 and Eylea HD in diabetic macular edema
Compares AVT29, a proposed biosimilar, with Eylea HD in adults with diabetic macular edema.
Plain-language title generated from the registry record
Registry title: Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema
Key facts
- Where
- Budapest, HungarySee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with diabetic macular edema, a swelling in the centre of the retina caused by diabetes, in the eye being studied.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Diabetic macular edema caused by diabetes, affecting the centre of the retina in the study eye. Vision score of 73 to 34 letters (20/40 to 20/200 Snellen equivalent). The vision loss must be mainly due to the macular edema.
- Earlier treatment
- People who had earlier anti-VEGF treatment cannot join.
Main reasons for not taking part
- Previous treatment with anti-VEGF therapy
- Another eye disease besides diabetic macular edema that could harm vision
- Any condition that the investigator thinks could interfere with taking part, pose a significant risk, or affect study data
- Medical or psychiatric conditions, or a risk of not following study procedures, as judged by the investigator
Read by machine on 12 November 2026.
Where in Hungary
- BudapestHospital not named in the registryContact: Silvia CirilloTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Alvotech Swiss AG
- Trial code
- NCT07489131
- Record updated
- 30 April 2026
- Original description
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.Read full original descriptionShow less
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
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.
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.