2025-522231-34-00RecruitingPhase 3
Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants with Diabetic Macular Edema
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Nov 2026
Brief summary (registry, in English)
To demonstrate the equivalent efficacy of AVT29 to Eylea HD in participants with diabetic macular edema (DME)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 243 (estimated)
- First submitted
- 30 Oct 2025
- Start date
- 31 Mar 2026
- Lead sponsor
- Alvotech Swiss AG
- Diseases
- Diabetic eye disease
- EU CT number
- 2025-522231-34-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 243
- 31 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (31)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Military Medical Academy | Sofiya | Bulgaria | Recruiting |
| University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD | Sofiya | Bulgaria | Recruiting |
| MBAL Trakia EOOD | Stara Zagora | Bulgaria | Recruiting |
| University Specialized Hospital For Eye Diseases For Active Treatment-Varna EOOD | Varna | Bulgaria | Recruiting |
| Outpatient-Medical Center For Specialized Medical Care-Eye Clinic Sveta Petka AD | Varna | Bulgaria | Recruiting |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | Czechia | Recruiting |
| VISUS, spol s.r.o. | Náchod | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze | Prague | Czechia | Recruiting |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Czechia | Recruiting |
| Axon Clinical s.r.o. | Prague 5 | Czechia | Recruiting |
| Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet | Budapest | Hungary | Recruiting |
| Semmelweis University | Budapest VIII | Hungary | Recruiting |
| Budapest Retina Associates Kft. | Budapest XIII | Hungary | Recruiting |
| University of Debrecen | Debrecen | Hungary | Recruiting |
| Nozologen Kft. | Pécs | Hungary | Recruiting |
| University of Szeged | Szeged | Hungary | Recruiting |
| Riga East University Hospital - Department of Ophthalmology, Clinical Center "Bikernieki" | Riga | Latvia | Recruiting |
| Ziemelkurzemes regionala slimnica SIA | Ventspils | Latvia | Recruiting |
| Szpital Swietego Lukasza S. A. | Bielsko-Biala | Poland | Recruiting |
| OFTALMIKA Sp. z o.o | Bydgoszcz | Poland | Recruiting |
| Centrum Medyczne Dietla 19 Sp. z o.o. | Cracow | Poland | Recruiting |
| Gabinet Okulistyczny prof. Edward Wylęgała | Katowice | Poland | Recruiting |
| Santa SP. z o.o | Lodz | Poland | Recruiting |
| Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o. | Olsztyn | Poland | Recruiting |
| Caminomed Sp. z o.o. | Tarnowskie Góry | Poland | Recruiting |
| F D Roosevelt University General Hospital Of Banska Bystrica | Banska Bystrica | Slovakia | Recruiting |
| University Hospital Bratislava | Bratislava | Slovakia | Recruiting |
| Euromedix a.s. | Petrzalka | Slovakia | Recruiting |
| Nemocnica Poprad, a.s. | Poprad | Slovakia | Recruiting |
| Nemocnica s poliklinikou Trebisov a.s. | Trebišov | Slovakia | Recruiting |
| Fakultna nemocnica Trencin | Trenčín | Slovakia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.