Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema
Recruiting
Phase 3
Interventional Study
Diabetic Macular Edema
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 256 (estimated)
- Sponsor
- Alvotech Swiss AG · Industry
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About This Trial
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.
Trial Locations
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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 inv…
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