The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)

EyePoint Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Nonproliferative Diabetic Retinopathy

Treatments: Drug: Placebo; Drug: AKB-9778

Study type: Interventional

Funder types: Industry

Identifiers

NCT03197870

AKB-9778-CI-5001

Details and patient eligibility

About

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 non-proliferative diabetic retinopathy (NPDR).

Enrollment: 167 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Adults 18 through 80 years of age (inclusive)
• Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive)
• No evidence of central involved diabetic macular edema
• ETDRS best-corrected visual acuity letter score ≥ 70 (Snellen 20/40 or better)

Key Exclusion Criteria:

• 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
• Evidence of neovascularization on clinical examination or imaging
• Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening
• Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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167 participants in 3 patient groups, including a placebo group

AKB-9778 15mg Daily

Experimental group

Description:

AKB-9778 15 mg (QD); To maintain masking, subjects will receive BID dosing with masked study medication administered as one dose of active and one dose of matching placebo

Treatment:

Drug: Placebo

Drug: AKB-9778

AKB-9778 15mg Twice Daily

Experimental group

Description:

AKB-9778 15 mg (BID)

Treatment:

Drug: AKB-9778

Placebo Twice Daily

Placebo Comparator group

Description:

Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID)

Treatment:

Drug: Placebo