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

Diabetic Macular Edema (DME) Clinical Trial

— TIME-2  

Official title:

A Phase 2, Randomized, Active-Controlled, Double-Masked, Multi-Center Study to Assess the Safety and Efficacy of Daily Subcutaneous AKB-9778 Administered for 3 Months, as Monotherapy or Adjunctive to Ranibizumab, in Subjects With Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050828
• Other study ID #: AKB-9778-CI-2003
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2014
• Last updated: March 15, 2017
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2017
• Source: Aerpio Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

The following is an abbreviated list of inclusion criteria:

• Adults between 18 to 80 years of age, inclusive

• Diagnosis of diabetes mellitus (type 1 or type 2)

• Decrease in vision in the study eye determined to be primarily the result of DME

• Definite retinal thickening due to diffuse DME involving the central macula in the study eye

• Central subfield thickness of at least 325 µm by sdOCT with presence of intraretinal fluid in the study eye

• ETDRS BCVA letter score = 76 and = 24 in the study eye

The following is an abbreviated list of exclusion criteria:

• Hemoglobin A1C (HbA1C) = 12.0% at Screening

• History of non infectious uveitis

• Decrease in visual acuity due to causes other than DME in the study eye

• History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):

1. Prior pars plana vitrectomy

2. Any ocular surgery within 3 months prior to Day 1

3. YAG capsulotomy within 3 months prior to Day 1

4. Panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Day 1 or anticipated need for PRP during the course of the study

5. Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1

6. Prior treatment with intravitreal anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1

Related Conditions & MeSH terms

• Diabetic Macular Edema (DME)
• Edema
• Macular Edema

Intervention

Drug:
• AKB-9778

• ranibizumab

• Placebo

• Sham

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aerpio Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST)		Month 3
Secondary	Mean change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)		Month 3