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Completed

NCT Number: NCT02050828

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

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.

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Key information

Conditions

Diabetic Macular Edema (DME)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pheonix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • Prior pars plana vitrectomy
  • Any ocular surgery within 3 months prior to Day 1
  • YAG capsulotomy within 3 months prior to Day 1
  • 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
  • Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1
  • Prior treatment with intravitreal anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1

Treatment and study plan

AKB-9778

Drug

ranibizumab

Drug

Other names: Lucentis

Placebo

Drug

sham

Drug

Primary outcomes

  1. Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST)

    Time frame: Month 3

Secondary outcomes

  1. Mean change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)

    Time frame: Month 3

Sponsors and collaborators

Lead sponsor

Aerpio Therapeutics

Industry

Registry information

Official study 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

Acronym: TIME-2

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 31, 2014
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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