Neovascular (Wet) AMDPhase 3ALVOEYENCT05155293
Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)
A Phase 3 study testing AVT06 (proposed aflibercept biosimilar) and Eylea® (Aflibercept) in people with Neovascular (Wet) AMD, run by Alvotech Swiss AG at 6 sites in 5 countries.
Trial summary
This is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in subjects with neovascular (wet) AMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular (Wet) AMD
- What is being tested?
- AVT06 (proposed aflibercept biosimilar) and Eylea® (Aflibercept)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 28 Jun 2022to 23 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be ≥50 years of age, at the time of signing the informed consent.
- Subjects must be diagnosed with neovascular (wet) AMD in the study eye.
- Subjects must have active, treatment naïve, subfoveal CNV lesions secondary to neovascular (wet) AMD.
- Willingness and ability to undertake all scheduled visits and assessments.
Who cannot join
- Any prior systemic treatment with anti-VEGF therapy
- 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
- Prior treatment with any investigational drugs within 30 days or 5 half-lives (whichever is longer) of the previous investigational treatment before initiation of the study treatment or concomitant enrollment in any other clinical study involving an investigational study treatment
- Subjects 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
6 sites in 5 countries.
6 sites in 5 countries
Latvia2 sites
Riga East University Hospital Clinical Centre "Bikernieki"
Riga, 10006
Pauls Stradins Clinical University Hospital SLLC
Riga, 1002
About this study
Official title: A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared With EU-Eylea® in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALVOEYE)
This is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in subjects with neovascular (wet) AMD.
- Conditions
- Neovascular (Wet) AMD
- Being tested
- AVT06 (proposed aflibercept biosimilar), Eylea® (Aflibercept)
- Keywords
- Macular Degeneration, Retinal Degeneration, Aflibercept
- Medical subject headings
- Macular Degeneration, Retinal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVT06 (proposed aflibercept biosimilar)Drug
Patients will receive IVT injections of AVT06
Eylea® (Aflibercept)Drug
Patients will receive IVT injections of Eylea®
| Study group | Role | What they receive |
|---|---|---|
| AVT06 (proposed aflibercept biosimilar) | Experimental | Patients will receive 1 IVT injection of AVT06 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. Receives: Drug: AVT06 (proposed aflibercept biosimilar) |
| Eylea® (Aflibercept) | Experimental | Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. Receives: Drug: Eylea® (Aflibercept) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA)
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 posted13 Dec 2021
- Study start28 Jun 2022
- Primary completion17 Nov 2023
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular (Wet) AMDStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvotech Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155293
- Sponsor's protocol ID
- AVT06-GL-C01
- Acronym
- ALVOEYE
- Status last verified
- Sep 2024
- First submitted
- 1 Dec 2021
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agostini H, Baumane K, Balciuniene VJ, Ozols K, Soni R, Hamdi S, Cirillo S, Rai M, Otto H, Leutz S, Sattar A, Berti F. A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opin Biol Ther. 2025 Jul;25(7):773-787. doi: 10.1080/14712598.2025.2519531. Epub 2025 Jun 17.
PubMed 40512025
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. 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 AVT06 Compared With EU-Eylea® in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALVOEYE)
- ClinicalTrials.gov ID
- NCT05155293
- Acronym / sponsor ID
- ALVOEYE / AVT06-GL-C01
- Conditions
- Neovascular (Wet) AMD
- Keywords
- Macular Degeneration, Retinal Degeneration, Aflibercept
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Alvotech Swiss AGIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 13 Dec 2021 (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, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in subjects with neovascular (wet) AMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVT06 (proposed aflibercept biosimilar) | Experimental | Drug: AVT06 (proposed aflibercept biosimilar)Patients will receive 1 IVT injection of AVT06 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. |
| Eylea® (Aflibercept) | Experimental | Drug: Eylea® (Aflibercept)Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be ≥50 years of age, at the time of signing the informed consent.
- Subjects must be diagnosed with neovascular (wet) AMD in the study eye.
- Subjects must have active, treatment naïve, subfoveal CNV lesions secondary to neovascular (wet) AMD.
- Willingness and ability to undertake all scheduled visits and assessments.
Key exclusion criteria (4 listed)
- Any prior systemic treatment with anti-VEGF therapy
- 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
- Prior treatment with any investigational drugs within 30 days or 5 half-lives (whichever is longer) of the previous investigational treatment before initiation of the study treatment or concomitant enrollment in any other clinical study involving an investigational study treatment
- Subjects 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.
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 |
|---|---|---|
| AVT06 (proposed aflibercept biosimilar)Patients will receive IVT injections of AVT06 | Drug | AVT06 (proposed aflibercept biosimilar) |
| Eylea® (Aflibercept)Patients will receive IVT injections of Eylea® | Drug | Eylea® (Aflibercept) |
Primary outcome
Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA)
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Derived from this study: PubMed 40512025Agostini H, Baumane K, Balciuniene VJ, Ozols K, Soni R, Hamdi S, Cirillo S, Rai M, Otto H, Leutz S, Sattar A, Berti F. A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opin Biol Ther. 2025 Jul;25(7):773-787. doi: 10.1080/14712598.2025.2519531. Epub 2025 Jun 17.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AVT06 (proposed aflibercept biosimilar) and Eylea® (Aflibercept) in people with Neovascular (Wet) AMD, run by Alvotech Swiss AG at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Latvia, Czechia, Georgia, Japan, Slovakia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA) (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05155293, which also lists 1 linked publication.
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 27 Sep 2024.