Frontlight ResearchEarly access
Taking people in HungaryPhase 3
Compares AVT29 with Eylea HD in people with diabetic macular edema
Tests AVT29 against Eylea HD in adults with diabetic macular edema.
Key facts
- Who runs it
- Alvotech Swiss AG
- Where
- Budapest, Budapest VIII, Budapest XIII, Debrecen, Pécs, and Szeged, HungarySee the 6 sitesAlso in 5 other countries, 25 sites
- Trial code
- Registry title
- Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants with Diabetic Macular Edema
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 243 people, planned
- Started
- 31 Mar 2026
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional
- Record updated
- 6 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 or type 2 diabetes who have diabetic macular edema (fluid swelling in the center of the retina). It compares AVT29 with Eylea HD.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Diabetic macular edema. The record gives no further stage or severity here.
- Biomarker or test result
- Type 1 or 2 diabetes with HbA1c below 12% (108 mmol/mol) at screening.
Main reasons for not taking part
- Proliferative diabetic retinopathy in the study eye
- Eye inflammation or infection within 90 days before screening
- Non-infectious, idiopathic or autoimmune uveitis
- Allergy to immunoglobulin products or to any component of the study treatments
- Uncontrolled blood pressure, or stroke, heart attack or blood clot within 180 days before baseline
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Hungary
Also in 5 other countries, 25 sites
- Budapesti Bajcsy-Zsilinszky Korhaz Es RendelointezetBudapest, HungaryTaking people
- Semmelweis UniversityBudapest VIII, HungaryTaking people
- Budapest Retina Associates Kft.Budapest XIII, HungaryTaking people
- University of DebrecenDebrecen, HungaryTaking people
- Nozologen Kft.Pécs, HungaryTaking people
- University of SzegedSzeged, HungaryTaking people
About the trial
What the trial wants to find out
To demonstrate the equivalent efficacy of AVT29 to Eylea HD in participants with diabetic macular edema (DME)
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Compares AVT29 with Eylea HD in people with diabetic macular edemaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 6 November 2026