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

Phase 2TerminatedNCT06181227

Aviceda Therapeutics, Inc.21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetic Macular Edema Diabetic Retinopathy

Interventions

AVD-104DRUG

An intravitreal injection of 50 microliters at the doses described will be given. Visual acuity, optical coherence tomography thickness and vascular perfusion will be evaluated for an effect of the drug.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

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

Outcomes

Primary Outcomes

Incidence of Serious Adverse Events

Number of participants with any evidence of serious adverse events as assessed by ocular examination

Time frame: 3 months

Secondary Outcomes

Treatment Effect

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)

Time frame: 3 months

Treatment Effect - Vision

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

Time frame: 3 months

Data from ClinicalTrials.gov

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