Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants with Diabetic Macular Edema
Key facts
- Where
- Budapest, Budapest VIII, Budapest XIII, Debrecen, Pécs és Szeged, MagyarországSee the 6 sites
- Phase
- 3. fázis
Where in Magyarország
- Budapesti Bajcsy-Zsilinszky Korhaz Es RendelointezetBudapest, MagyarországTaking people
- Semmelweis UniversityBudapest VIII, MagyarországTaking people
- Budapest Retina Associates Kft.Budapest XIII, MagyarországTaking people
- University of DebrecenDebrecen, MagyarországTaking people
- Nozologen Kft.Pécs, MagyarországTaking people
- University of SzegedSzeged, MagyarországTaking 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?
Trial details
- Who runs it
- Alvotech Swiss AG
- Trial code
- EU 2025-522231-34-00
- Record updated
- 2026. november 6.
- Original description
To demonstrate the equivalent efficacy of AVT29 to Eylea HD in participants with diabetic macular edema (DME)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 High Dose (HD) in Participants with Diabetic Macular Edema (ALVOEYE-HD)
To demonstrate the equivalent efficacy of AVT29 to Eylea HD in participants with diabetic macular edema (DME)
Inclusion: Participant reads, understands, and signs an independent ethics committee (IEC)/institutional review board (IRB) approved informed consent form (ICF) prior to any study-specific procedure. If the participant is unable to read and/or write, an impartial witness should be present during the entire informed consent discussion; Participant is ≥18 years old at the time of signing the ICF; Participant has a diagnosis of type 1 or 2 diabetes mellitus (DM) with glycated hemoglobin (HbA1c) <12% at screening. For the full list of inclusion criteria please refer to protocol.
Exclusion: Participant has a history of one or more of the following ocular conditions in the study eye: a. Any intraocular inflammation/infection within 90 days prior to screening. b. Non-infectious uveitis, or idiopathic or autoimmune uveitis. For the full list of ocular conditions please refer to protocol; Participant currently suffering from or having a history of (where indicated) one or more of the following systemic conditions: a. Uncontrolled blood pressure b. History of vascular disease such as cerebrovascular accident, myocardial infarction, transient ischemic attack, or thromboembolic reaction including pulmonary embolism within 180 days prior to baseline c. New York Heart Association Functional Classification Class III or IV heart failure, or severe uncontrolled cardiac disease (ie, unstable angina). For the full list of exclusion criteria please refer to protocol; Participant has one or more of the following current ocular conditions in the study eye: a. Proliferative diabetic retinopathy. b. Pre-retinal fibrosis involving the macula. c. Aphakia or absence of the posterior capsule. For the full list of ocular conditions please refer to protocol; Participant has a hypersensitivity to immunoglobulin products, or has allergies to any of the components of the study treatments.