The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema

Phase 2

Completed

• Conditions: Diabetic Macular Edema (DME)
• Interventions: Drug: AKB-9778; Drug: Sham; Drug: ranibizumab; Drug: Placebo

• Registration Number: NCT02050828
• Lead Sponsor: Aerpio Therapeutics

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of AKB-9778 administered as daily subcutaneous injections with and without monthly intravitreal injections of ranibizumab for 3 months in patients with diabetic macular edema.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Disposition First Submitted: 2015-08-24
• Disposition First Submitted QC: 2015-08-24
• Disposition First Posted: 2015-09-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AKB-9778 15 mg BID monotherapy	Sham	Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus monthly sham intravitreal injection for 3 months.
AKB-9778 15 mg BID + ranibizumab 0.3 mg	AKB-9778	Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
AKB-9778 15 mg BID monotherapy	AKB-9778	Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus monthly sham intravitreal injection for 3 months.
AKB-9778 15 mg BID + ranibizumab 0.3 mg	ranibizumab	Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
ranibizumab 0.3 mg monotherapy	ranibizumab	Placebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
ranibizumab 0.3 mg monotherapy	Placebo	Placebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST)	Month 3

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)	Month 3