A Phase 2 Study to Evaluate the Safety and Treatment Effect of Intravitreal AVD-104 in Participants With Diabetic Macular Edema

AVD-104-C301

A Phase 2 study to determine the safety and preliminary efficacy of intravitreal injections of AVD-104, a novel glyco-mimetic nanoparticle, in reducing macular edema associated with diabetic retinopathy.

2023-11-30

2024-04-05

2024-04-05

Terminated

Early phase I

21

Inclusion Criteria: * Diagnosis of diabetes mellitus (type 1 or 2), as defined by the World Health Organization and/or American Diabetes Association * Decreased visual acuity (VA) due to DME, with BCVA letter score of 75-20 letters on ETDRS-like charts (20/32-20/320 Snellen equivalent) * DME represented by macular thickening on SD-OCT involving the center of the macula: CST ≥325 μm Exclusion Criteria: * Any IVT anti-vascular endothelial growth factor (VEGF) treatment within 3 months before randomization * Any history of pan-retinal photocoagulation (PRP) treatment * Any use of Iluvien® (Alimera Sciences, Inc., Alpharetta, GA) in the last 3 years; or Ozurdex® (Abbvie, Chicago, IL) or Xipere (Bausch \& Lomb, Vaughan, Ontario, Canada) in the last 6 months * History of macular laser photocoagulation * Any signs of high-risk proliferative diabetic retinopathy (PDR)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 21, 'type': 'ACTUAL'}}

2024-04-24