Overview

This trial is active, not recruiting.

Condition diabetic macular edema (dme)
Treatments akb-9778, ranibizumab
Phase phase 2
Target VEGF
Sponsor Aerpio Therapeutics
Start date January 2014
End date April 2015
Trial size 144 participants
Trial identifier NCT02050828, AKB-9778-CI-2003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus monthly sham intravitreal injection for 3 months.
akb-9778
(Experimental)
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
ranibizumab Lucentis
(Active Comparator)
Placebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
ranibizumab Lucentis

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Aerpio Therapeutics.