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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06181227
• Other study ID #: AVD-104-C301
• Status: Terminated
• Phase: Phase 2
• 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
• 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)

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema

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