NCT07489131 Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema
| NCT ID | NCT07489131 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alvotech Swiss AG |
| Condition | Diabetic Macular Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2026-04-22 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 256 participants in total. It began in 2026-04-22 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07489131 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Macular Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07489131 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 256 participants.
Is NCT07489131 currently recruiting?
Yes, NCT07489131 is actively recruiting participants. Contact the research team at alvotech.clinical@alvotech.com for enrollment information.
Where is the NCT07489131 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT07489131 clinical trial?
NCT07489131 is sponsored by Alvotech Swiss AG. The trial plans to enroll 256 participants.