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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT06181227
Other study ID # AVD-104-C301
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 30, 2023
Est. completion date April 5, 2024

Study information

Verified date December 2023
Source Aviceda Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Aviceda Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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