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

Stopped early · Phase 2

Conditions studied: Diabetic Macular Edema, Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT06181227

Run by

Aviceda Therapeutics, Inc.

People needed

21

Starts

2023-11-30

Expected to finish

2024-04-05

Last updated by the study team

2025-07-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Best corrected visual acuity (BCVA) letter score of 75-20 letters on ETDRS-like charts (20/32-20/320 Snellen equivalent)
• DME represented by macular thickening on Spectral domain optical coherence tomography (SD-OCT) involving the center of the macula: Central subfield thickness (CST) ≥325 μm

You may not qualify if…

• 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)

Where it is running

• Erie Retina Research — Erie, Pennsylvania, United States
• Texas Retina Associates — Dallas, Texas, United States
• West Texas Retina Consultants — Wichita Falls, Texas, United States

Full record on ClinicalTrials.gov

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