Status:
COMPLETED
Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease
Lead Sponsor:
Alvotech Swiss AG
Conditions:
Chorioretinal Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 option...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- 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
- Exclusion Criteria (selected):
- 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
Exclusion
Key Trial Info
Start Date :
February 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05986786
Start Date
February 28 2024
End Date
March 21 2025
Last Update
April 22 2025
Active Locations (1)
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1
4001
Tbilisi, Georgia