Diabetic Retinopathy Clinical Trial
Official title:
A Phase 2 Study to Evaluate the Safety and Treatment Effect of Intravitreal AVD-104 in Participants With Diabetic Macular Edema
Verified date | December 2023 |
Source | Aviceda Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Terminated |
Enrollment | 21 |
Est. completion date | April 5, 2024 |
Est. primary completion date | April 5, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 BCVA letter score of 75-20 letters on ETDRS-like charts (20/32-20/320 Snellen equivalent) - DME represented by macular thickening on SD-OCT involving the center of the macula: CST =325 µm Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United States | Texas Retina Associates | Dallas | Texas |
United States | Erie Retina Research | Erie | Pennsylvania |
United States | West Texas Retina Consultants | Wichita Falls | Texas |
Lead Sponsor | Collaborator |
---|---|
Aviceda Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of AVD-104 | Number of participants with any evidence of adverse or serious adverse events as assessed by ocular examination | 3 months | |
Secondary | Treatment effect | Evaluate the treatment effect of AVD-104 at multiple doses on central subfield thickness (CST) as measured by Spectral-domain optical coherence tomography (SD-OCT) | 3 months | |
Secondary | Treatment effect - vision | Evaluate the treatment effect of AVD-104 at multiple doses on Best-corrected visual acuity (BCVA) using ETDRS ((Early-Treatment Diabetic Retinopathy Study) visual acuity charts | 3 months |
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