Recent Updates
Recently added Catalysts

AVT29

Phase 3

Diabetic Macular Edema | Small molecule | Ophthalmology |Alvotech|Last Updated: Apr 30, 2026

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment256
FDA Designations
No designations recorded
Clinical trial landscape

AVT29 · 1 trial · 1 indication

Phase 3 1
NCT07489131Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular EdemaDiabetic Macular Edema
RECRUITING256 Analytics
PHASE3RECRUITING
Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema
Diabetic Macular EdemaUnlock trial analytics
Study Endpoints
Primary Endpoints
Change from baseline to Week 8 in BCVA as measured by ETDRS letter score
week 8
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AVT29 (proposed aflibercept HD biosimilar)EXPERIMENTALParticipants 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_COMPARATORParticipants 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.
Interventions
NameTypeDescription
AVT29 (proposed aflibercept HD biosimilar)DRUGPatients will receive IVT injections of AVT29
Eylea HD (aflibercept HD)DRUGPatients will receive IVT injections of Eylea HD
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 inv...

Countries:Hungary
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07489131primaryCompletionDate: changed
LOWMay 24, 2026NCT07489131studyFirstPostDate: changed