NCT06181227

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Aviceda Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema
• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	AVD-104	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.

Timeline

• Start date: 2023-11-30
• Primary completion: 2024-04-05
• Completion: 2024-04-05
• First posted: 2023-12-26
• Last updated: 2025-07-14
• Results posted: 2025-07-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study