Actively Recruiting
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
Led by Alvotech Swiss AG · Updated on 2026-04-30
256
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of AVT29 compared with Eylea HD in adults with diabetic macular edema (DME). This randomized, double-masked, parallel-group, multicenter clinical study focuses on participants diagnosed with DME secondary to diabetes mellitus who have central involvement in the study eye. The trial aims to assess vision improvement and safety outcomes in this population. Participants will receive intravitreal (IVT) injections of either AVT29, a proposed aflibercept HD biosimilar, or Eylea HD (aflibercept HD). Each participant will get one injection at the start of the study and additional injections every 4 weeks for two months (at Week 4 and Week 8). After this initial period, injections will continue every 8 to 16 weeks based on diabetic retinopathy management criteria until the study ends. During the study, participants will be monitored for changes in best-corrected visual acuity (BCVA) using the ETDRS letter score, particularly from baseline to Week 8. Regular visits will involve eye exams and safety assessments. The total duration of participation depends on the study timeline, and the research team will carefully track vision changes and any treatment-related effects throughout the trial.
CONDITIONS
Brief Title
Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years 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 before randomization.
- Participant's vision decrease is primarily due to diabetic macular edema in the study eye.
You will not qualify if you...
- Previous treatment with anti-VEGF therapy.
- History or presence of another eye disease besides diabetic macular edema that could affect vision.
- Any condition that, in the investigator's opinion, could interfere with full participation, pose significant risk, or affect study results.
- Participants judged unsuitable for participation due to medical, psychiatric, or compliance reasons by the investigator.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 18 months
Participants receive intravitreal injections of either AVT29 or Eylea HD. Injections occur at baseline and every 4 weeks for the first 8 weeks, then every 8 to 16 weeks based on diabetic retinopathy macular edema (DRM) criteria through study completion.
Visits at baseline, Week 4, Week 8, and then every 8 to 16 weeks
Trial Site Locations
Total: 1 location
1
Site 3004
Budapest, Hungary
Actively Recruiting
Research Team
S
Silvia Cirillo
R
Riken Soni
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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