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

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

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.

The primary objective is to evaluate the tolerability and treatment effect of intravitreal injections (IVT) of AVD-104 in participants with diabetic macular edema (DME). Participants will receive either three intravitreal injections of low-dose AVD-104 (1.0 mg) each 28 days apart or two intravitreal injections of AVD-104 at a high-dose (2.0 mg) 56 days apart. Serial optical coherence tomography (OCT), ultra wide-field fluorescein angiography, and OCT-angiography (OCT-A) will be performed to evaluate the treatment effect on central subfield thickness (CST) and areas of non-perfusion. All participants will be followed-up for safety until day 84.

There will be a planned enrollment up to 30 participants.

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 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

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)