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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07489131
- Acronym / sponsor ID
- ALVOEYE-HD / AVT29-GL-C01
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Alvotech Swiss AGIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVT29 (proposed aflibercept HD biosimilar) | Experimental | Drug: AVT29 (proposed aflibercept HD biosimilar)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. |
| Eylea HD (aflibercept HD) | Active comparator | Drug: Eylea HD (aflibercept HD)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVT29 (proposed aflibercept HD biosimilar)Patients will receive IVT injections of AVT29 | Drug | AVT29 (proposed aflibercept HD biosimilar) |
| Eylea HD (aflibercept HD)Patients will receive IVT injections of Eylea HD | Drug | Eylea HD (aflibercept HD) |
Primary outcome
Change from baseline to Week 8 in BCVA as measured by ETDRS letter score
Time frame: week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Riken Soni contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Cirillo (+41 78 659 89 89, alvotech.clinical@alvotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Week 8 in BCVA as measured by ETDRS letter score (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.