Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants with Diabetic Macular Edema

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Alvotech Swiss AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

31 Mar 2026 → ongoing

Decision date (initial)

2026-03-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Alvotech Swiss AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Safety

To demonstrate the equivalent efficacy of AVT29 to Eylea HD in participants with diabetic macular edema (DME)

Secondary objectives 4

1. Efficacy: To further assess the efficacy of AVT29 compared with Eylea HD
2. Safety: To evaluate the safety and tolerability of AVT29 compared with Eylea HD
3. Immunogenicity: To assess the immunogenicity of AVT29 compared with Eylea HD
4. Pharmacokinetics: To evaluate the systemic pharmacokinetics (PK) of AVT29 and Eylea HD in a subset of participants

Conditions and MedDRA coding

Diabetic Macular Edema

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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.
2. Participant is ≥18 years old at the time of signing the ICF.
3. 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 criteria 4

1. 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.
2. 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.
3. Participant has a hypersensitivity to immunoglobulin products, or has allergies to any of the components of the study treatments
4. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in best-corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score

Secondary endpoints 12

1. Change from baseline in BCVA as assessed by ETDRS letter score throughout the study at several pre-defined time points
2. Gain of ≥5, ≥10, and ≥15 letter score in BCVA by ETDRS from baseline throughout the study at several pre-defined time points
3. Loss of ≥5, ≥10, and ≥15 letter score in BCVA by ETDRS from baseline throughout the study at several pre-defined time points
4. Change from baseline in central subfield thickness (CST) as assessed by spectral domain optical coherence tomography (SD-OCT) throughout the study at several pre-defined time points
5. Absence of intraretinal fluid (IRF) as assessed by SD-OCT from baseline throughout the study at several pre-defined time points
6. Absence of intraretinal fluid (IRF) as assessed by SD-OCT from baseline throughout the study at several pre-defined time points during the trial
7. Incidence of ocular and non-ocular treatment-emergent adverse events, adverse events of special interest, and serious adverse events
8. Evaluation of ophthalmic parameters (intraocular pressure [IOP], biomicroscopy, and indirect ophthalmoscopy)
9. Evaluation of routine safety parameters
10. Incidence and titer of anti-drug antibodies at several pre-defined time points during the study
11. Incidence of neutralizing antibodies at several pre-defined time points during the study
12. Evaluation of the systemic PK of free and bound aflibercept at several pre-defined time points during the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Alvotech Swiss AG

Sponsor organisation

Alvotech Swiss AG

Address

Thurgauerstrasse 54

City

Zurich

Postcode

8050

Country

Switzerland

Scientific contact point

Organisation

Alvotech Swiss AG

Contact name

Riken Soni

Public contact point

Organisation

Alvotech Swiss AG

Contact name

Silvia Cirillo

Third parties 10

Locations

6 EU/EEA countries · 31 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 81 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications