A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema

• Status: Terminated
• Trial end date: 2024-04-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aviceda Therapeutics, Inc.

Criteria

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)