NCT07489131RecruitingPhase 3
Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema
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
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 256 (estimated)
- First submitted
- 19 Mar 2026
- Start date
- 22 Apr 2026
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Alvotech Swiss AG
- Diseases
- Diabetic eye disease
- NCT number
- NCT07489131
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 256
- From 22 Apr 2026 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Site 3004 Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.