Diabetic Macular EdemaPhase 3ALVOEYE-HDNCT07489131
Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema
A Phase 3 study testing AVT29 (proposed aflibercept HD biosimilar) and Eylea HD (aflibercept HD) in people with Diabetic Macular Edema, run by Alvotech Swiss AG at 1 site in Hungary.
Trial summary
This is a Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea HD in Participants with Diabetic Macular Edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- AVT29 (proposed aflibercept HD biosimilar) and Eylea HD (aflibercept HD)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteHungary
- Study dates
- 22 Apr 2026to Jan 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Participant is ≥18 years old at the time of signing the ICF.
- Participant is willing and able to comply with all study procedures and likely to complete the study, based on the investigator's judgment.
- Participant has a diagnosis of DME secondary to DM with central involvement in the study eye.
- Participant has a BCVA ETDRS letter score of 73 to 34 letters inclusive (20/40 to 20/200 Snellen equivalent) in the study eye at screening and on Day 1 prior randomization.
- Participant's decrease in vision is determined to be primarily the result of DME in the study eye.
Main Exclusion Criteria:
- previous treatment with anti-VEGF therapy
- history or concurrent disease other than DME that could compromise visual acuity
- Any condition that, in the Investigator ́s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data
- participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Riken Soni contact
About this study
Official title: A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared With Eylea HD in Participants With Diabetic Macular Edema
This is a Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea HD in Participants with Diabetic Macular Edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- AVT29 (proposed aflibercept HD biosimilar), Eylea HD (aflibercept HD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVT29 (proposed aflibercept HD biosimilar)Drug
Patients will receive IVT injections of AVT29
Eylea HD (aflibercept HD)Drug
Patients will receive IVT injections of Eylea HD
| Study group | Role | What they receive |
|---|---|---|
| AVT29 (proposed aflibercept HD biosimilar) | Experimental | Participants will receive 1 IVT injection of AVT29 at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion. Receives: Drug: AVT29 (proposed aflibercept HD biosimilar) |
| Eylea HD (aflibercept HD) | Active comparator | Participants will receive 1 IVT injection of Eylea HD at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion. Receives: Drug: Eylea HD (aflibercept HD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 8 in BCVA as measured by ETDRS letter score
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start22 Apr 2026
- Primary completionJul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alvotech Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489131
- Sponsor's protocol ID
- AVT29-GL-C01
- Acronym
- ALVOEYE-HD
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No