This is a Clinical Research Study of AKB-9778, a Novel Tie 2 Activator, in patients with Non-Proliferative Diabetic Retinopathy (NPDR). The purpose of this study is to evaluate the safety and efficacy of subcutaneously administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with moderate to severe NPDR.
BASIC TRIAL INFORMATION:
Disease: Nonproliferative Diabetic Retinopathy
Age: 18 Years to 80 Years
Sponsor: Aerpio Therapeutics
Status: Currently Enrolling
Length: 12 Months
Key Inclusion Criteria:
1. Adults 18 through 80 years of age (inclusive).
2. Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive.
3. No evidence of central involved Diabetic Macular Edema.
4. ETDRS BCVA letter score ≥ 70 (Snellen 20/40 or better).
Key Exclusion Criteria:
1. Ocular disease other than DR that may cause substantial reduction in visual acuity, including iris neovascularization, retinal detachment, visually significant epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases.
2. Evidence of neovascularization on clinical examination or imaging.
3. Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening.
4. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
STUDY TITLE: Phase 2 Double-Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of Subcutaneously Administered AKB-9778 15mg Once Daily or 15mg Twice Daily for 12 Months in Patients With Moderate to Severe Non-Proliferative Diabetic Retinopathy.
TRIAL CONTACT INFORMATION:
Site: Beachwood Office, Middleburg Heights, and Youngstown
Study Coordinator: Janine Davis
Site: Middleburg Heights Office
Study Coordinator: Susan Rath
Site: Youngstown Office
Study Coordinator: John Lacombe