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

NCT06181227 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: AVD-104-C301
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetic Macular Edema; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Adverse Events

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

  3 months

Secondary Outcomes (2)

• Treatment Effect

  3 months

• Treatment Effect - Vision

  3 months

Study Arms (2)

Low dose AVD-104

EXPERIMENTAL

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.

Drug: AVD-104

High dose AVD-104

EXPERIMENTAL

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.

Drug: AVD-104

Interventions

AVD-104 DRUG

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.

High dose AVD-104; Low dose AVD-104

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aviceda Therapeutics, Inc.: lead

Study Sites (3)

Erie Retina Research

Erie, Pennsylvania, 16507, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

West Texas Retina Consultants

Wichita Falls, Texas, 76309, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: David Callanan
• Organization: Aviceda Therapeutics

dcallanan@avicedarx.com

817-312-9258

Study Officials

• David Callanan, MD

  Aviceda Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 26, 2023
• Study Start: November 30, 2023
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-07

Locations

US (3)