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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06181227
Study type	Interventional
Source	Aviceda Therapeutics, Inc.
Contact
Status	Terminated
Phase	Phase 2
Start date	November 30, 2023
Completion date	April 5, 2024

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