NCT06181227TerminatedPhase 2
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
Source: ClinicalTrials.gov · Last updated 14 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 28 Nov 2023
- Start date
- 30 Nov 2023
- Primary completion date
- 5 Apr 2024
- Lead sponsor
- Aviceda Therapeutics, Inc.
- Diseases
- Diabetic eye disease
- NCT number
- NCT06181227
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any IVT anti-vascular endothelial growth factor (VEGF) treatment within 3 months before randomization
Other illness
- Any history of pan-retinal photocoagulation (PRP) treatment
- History of macular laser photocoagulation
Other
- 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
- Any signs of high-risk proliferative diabetic retinopathy (PDR)
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Retina Associates | Dallas | United States | Unknown status |
| Erie Retina Research | Erie | United States | Unknown status |
| West Texas Retina Consultants | Wichita Falls | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.