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

Phase 2

Terminated

• Conditions: Diabetic Retinopathy; Diabetic Macular Edema
• Interventions: Drug: AVD-104

• Registration Number: NCT06181227
• Lead Sponsor: Aviceda Therapeutics, Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-11-28
• Study Start: 2023-11-30
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-26
• Primary Completion: 2024-04-05
• Study Completion: 2024-04-05
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose AVD-104	AVD-104	Three intravitreal injections at 1.0 milligram per eye each 28 days apart will be administered to the study eye. Participants will be followed for 84 days total.
High dose AVD-104	AVD-104	Two intravitreal injections at 2.0 milligrams per eye 56 days apart will be administered to the study eye. Participants will be followed for 84 days total.

Primary Outcome Measures

Name	Time	Method
Safety of AVD-104	3 months	Number of participants with any evidence of adverse or serious adverse events as assessed by ocular examination

Secondary Outcome Measures

Name	Time	Method
Treatment effect	3 months	Evaluate the treatment effect of AVD-104 at multiple doses on central subfield thickness (CST) as measured by Spectral-domain optical coherence tomography (SD-OCT)
Treatment effect - vision	3 months	Evaluate the treatment effect of AVD-104 at multiple doses on Best-corrected visual acuity (BCVA) using ETDRS ((Early-Treatment Diabetic Retinopathy Study) visual acuity charts

Trial Locations

Locations (3)

Erie Retina Research; 🇺🇸 Erie, Pennsylvania, United States

Texas Retina Associates; 🇺🇸 Dallas, Texas, United States

West Texas Retina Consultants; 🇺🇸 Wichita Falls, Texas, United States