Diabetic Macular Edema
Conditions
Brief 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.
Interventions
DRUGAVT29 (proposed aflibercept HD biosimilar)
Patients will receive IVT injections of AVT29
DRUGEylea HD (aflibercept HD)
Patients will receive IVT injections of Eylea HD
Sponsors
Alvotech Swiss AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 8 in BCVA as measured by ETDRS letter score | week 8 |
Countries
Hungary
Contacts
CONTACTSilvia Cirillo
CONTACTRiken Soni
Outcome results
None listed