Status:
TERMINATED
A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema
Lead Sponsor:
Aviceda Therapeutics, Inc.
Conditions:
Diabetic Macular Edema
Diabetic Retinopathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 retinopat...
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 eith...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06181227
Start Date
November 30 2023
End Date
April 5 2024
Last Update
July 14 2025
Active Locations (3)
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1
Erie Retina Research
Erie, Pennsylvania, United States, 16507
2
Texas Retina Associates
Dallas, Texas, United States, 75231
3
West Texas Retina Consultants
Wichita Falls, Texas, United States, 76309