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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02050828

Acronym

TIME-2

Enrollment

144

Registered

2014-01-31

Start date

2014-01-31

Completion date

2015-05-31

Last updated

2017-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema (DME)

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.

Interventions

DRUGAKB-9778

DRUGranibizumab

DRUGPlacebo

DRUGSham

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026