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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

Next steps

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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (31)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Military Medical AcademySofiyaBulgariaRecruiting
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EADSofiyaBulgariaRecruiting
MBAL Trakia EOODStara ZagoraBulgariaRecruiting
University Specialized Hospital For Eye Diseases For Active Treatment-Varna EOODVarnaBulgariaRecruiting
Outpatient-Medical Center For Specialized Medical Care-Eye Clinic Sveta Petka ADVarnaBulgariaRecruiting
Fakultni nemocnice Hradec KraloveHradec KrálovéCzechiaRecruiting
VISUS, spol s.r.o.NáchodCzechiaRecruiting
Vseobecna fakultni nemocnice v PrazePragueCzechiaRecruiting
Fakultni nemocnice Kralovske VinohradyPragueCzechiaRecruiting
Axon Clinical s.r.o.Prague 5CzechiaRecruiting
Budapesti Bajcsy-Zsilinszky Korhaz Es RendelointezetBudapestHungaryRecruiting
Semmelweis UniversityBudapest VIIIHungaryRecruiting
Budapest Retina Associates Kft.Budapest XIIIHungaryRecruiting
University of DebrecenDebrecenHungaryRecruiting
Nozologen Kft.PécsHungaryRecruiting
University of SzegedSzegedHungaryRecruiting
Riga East University Hospital - Department of Ophthalmology, Clinical Center "Bikernieki"RigaLatviaRecruiting
Ziemelkurzemes regionala slimnica SIAVentspilsLatviaRecruiting
Szpital Swietego Lukasza S. A.Bielsko-BialaPolandRecruiting
OFTALMIKA Sp. z o.oBydgoszczPolandRecruiting
Centrum Medyczne Dietla 19 Sp. z o.o.CracowPolandRecruiting
Gabinet Okulistyczny prof. Edward WylęgałaKatowicePolandRecruiting
Santa SP. z o.oLodzPolandRecruiting
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.OlsztynPolandRecruiting
Caminomed Sp. z o.o.Tarnowskie GóryPolandRecruiting
F D Roosevelt University General Hospital Of Banska BystricaBanska BystricaSlovakiaRecruiting
University Hospital BratislavaBratislavaSlovakiaRecruiting
Euromedix a.s.PetrzalkaSlovakiaRecruiting
Nemocnica Poprad, a.s.PopradSlovakiaRecruiting
Nemocnica s poliklinikou Trebisov a.s.TrebišovSlovakiaRecruiting
Fakultna nemocnica TrencinTrenčínSlovakiaRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.