Chorioretinal Vascular DiseasePhase 3ALVOEYE-DNCT05986786
Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease
A Phase 3 study testing Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule in people with Chorioretinal Vascular Disease, run by Alvotech Swiss AG at 1 site in Georgia.
Trial summary
This is a single-arm, open label, multicenter clinical study to evaluate the handling and safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease followed by an optional extension phase of AVT06 pre-filled syringe (PFS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chorioretinal Vascular Disease
- What is being tested?
- Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGeorgia
- Study dates
- 28 Feb 2024to 21 Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years old
- Subjects with diagnosis of nAMD (wet), DME, RVO, DR, or myopic CNV in the study eye
- Study eye considered by the Principal Investigator to be indicated for treatment with aflibercept
- Subjects must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form (ICF) before any study-specific procedures
- Willing and able to comply with all study procedures and be likely to complete the study
- Subjects must be able to follow the contraception requirements
Who cannot join
- Any concurrent ocular condition in the study eye which, in the opinion of the Principal Investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of safety
- Current systemic infectious disease or a therapy for active infectious disease Any condition that, in the Principal 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 subject, or interfere with interpretation of study data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-arm, Open Label, Multicenter Clinical Study to Evaluate the Handling and Safety of AVT06 Pre-filled Syringe (PFS) in Subjects With Chorioretinal Vascular Disease Followed by an Optional Extension Phase of AVT06 Pre-filled Syringe (PFS)
This is a single-arm, open label, multicenter clinical study to evaluate the handling and safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease followed by an optional extension phase of AVT06 pre-filled syringe (PFS)
- Conditions
- Chorioretinal Vascular Disease
- Being tested
- Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease scheduleDevice
Patient will receive AVT06 (proposed aflibercept biosimilar) PFS injection
| Study group | Role | What they receive |
|---|---|---|
| AVT06 (proposed aflibercept biosimilar) PFS | Experimental | IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06 Receives: Device: Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS.
Proportion of AVT06 injections successfully administered with PFS at Day 1
Measured: Day 1
Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4 to evaluate ocular safety of AVT06 delivered from the PFS
Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start28 Feb 2024
- Primary completion19 Apr 2024
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chorioretinal Vascular DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvotech Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans-Juergen Agostini, Principal investigator, University Clinic Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986786
- Sponsor's protocol ID
- AVT06-GL-D01
- Acronym
- ALVOEYE-D
- Status last verified
- Apr 2025
- First submitted
- 3 Aug 2023
- Last updated
- 22 Apr 2025
- 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Open Label, Multicenter Clinical Study to Evaluate the Handling and Safety of AVT06 Pre-filled Syringe (PFS) in Subjects With Chorioretinal Vascular Disease Followed by an Optional Extension Phase of AVT06 Pre-filled Syringe (PFS)
- ClinicalTrials.gov ID
- NCT05986786
- Acronym / sponsor ID
- ALVOEYE-D / AVT06-GL-D01
- Conditions
- Chorioretinal Vascular Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Alvotech Swiss AGIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 14 Aug 2023 (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 single-arm, open label, multicenter clinical study to evaluate the handling and safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease followed by an optional extension phase of AVT06 pre-filled syringe (PFS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVT06 (proposed aflibercept biosimilar) PFS | Experimental | Device: Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease scheduleIVT injection with a PFS containing the proposed aflibercept biosimilar AVT06 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥18 years old
- Subjects with diagnosis of nAMD (wet), DME, RVO, DR, or myopic CNV in the study eye
- Study eye considered by the Principal Investigator to be indicated for treatment with aflibercept
- Subjects must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form (ICF) before any study-specific procedures
- Willing and able to comply with all study procedures and be likely to complete the study
Key exclusion criteria (2 listed)
- Any concurrent ocular condition in the study eye which, in the opinion of the Principal Investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of safety
- Current systemic infectious disease or a therapy for active infectious disease Any condition that, in the Principal 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 subject, or interfere with interpretation of study data
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 |
|---|---|---|
| Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedulePatient will receive AVT06 (proposed aflibercept biosimilar) PFS injection | Device | AVT06 (proposed aflibercept biosimilar) PFS |
Primary outcome
Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS.
Time frame: Day 1
Proportion of AVT06 injections successfully administered with PFS at Day 1
Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4 to evaluate ocular safety of AVT06 delivered from the PFS
Time frame: Week 4
Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4
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 22 Apr 2025.
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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.
Hans-Juergen Agostini principal investigator
University Clinic Freiburg
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 Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule in people with Chorioretinal Vascular Disease, run by Alvotech Swiss AG at 1 site in Georgia.
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 6 inclusion and 2 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 22 Apr 2025. 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 Georgia. 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?
Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS. (time frame: Day 1). The study lists 2 primary outcomes in all. 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 22 Apr 2025.