Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema

Phase 1b/2a Open Label, Multiple-Ascending Dose Cohort Study to Assess the Safety, Tolerability, Pilot Efficacy, Pharmacokinetics and Pharmacodynamic Effects of 28 Day Repeat Subcutaneous Doses of AKB-9778 in Subjects With Diabetic Macular Edema

The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections daily for 28 days in patients with diabetic macular edema (DME).

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema (DME)
• Intervention / Treatment: Drug: Subcutaneous AKB-9778

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States
  • Florida
    • Winter Haven, Florida, United States
  • Maryland
    • Baltimore, Maryland, United States
  • Massachusetts
    • Boston, Massachusetts, United States
  • North Carolina
    • Charlotte, North Carolina, United States
  • Ohio
    • Cincinnati, Ohio, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 determined to be primarily the result of DME in the study eye
• Definite Retinal thickening due to diffuse DME involving the center of the macula in the study eye
• Mean central subfield thickness of at least 325 µm by OCT in the study eye
• Early Treatment Diabetic Retinopathy Study (ETDRS) letter score BCVA ≤ 70 (20/40) in the study eye

Exclusion Criteria:

The following is an abbreviated list of exclusion criteria:

• Hemoglobin A1C (HbA1C) ≥ 11.5%

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

  1. Panretinal scatter photocoagulation (PRP) or focal laser within 12 weeks prior to Screening
  2. Prior pars plana vitrectomy within 12 weeks prior to Screening
  3. Any ocular surgery within 12 weeks prior to Screening
  4. YAG capsulotomy within 7 days prior to Screening
  5. Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Screening or prior treatment with intravitreal anti-VEGF treatment within 1 month of Screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AKB-9778; Up to 4 dose levels of subcutaneous AKB-9778 will be evaluated. Doses will be administered daily for 28 days.	Drug: Subcutaneous AKB-9778

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events (AEs).		28 days
Change from baseline in physical exams.		28 days
Change from baseline in vital signs.		28 days
Change from baseline in electrocardiograms (ECGs).		28 days
Change from baseline in opthalmic exams.		28 days
Change from baseline in clinical laboratory assay results.	Blood chemistry, hematology and urinalysis.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of AKB-9778	Maximum plasma drug concentration (Cmax). Area under the plasma concentration-time curve (AUC).	Day 1 and Day 14
Change from baseline in optical tomography (OCT)-measured retinal thickness.		28 days
Change from baseline in best corrected visual acuity (BCVA).		28 days

Collaborators and Investigators

• Sponsor: Aerpio Therapeutics
• Investigators: Study Director: Kevin Peters, MD, Aerpio Therapeutics

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 24, 2012
• First Submitted That Met QC Criteria: October 5, 2012
• First Posted (Estimate): October 8, 2012

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: AKB-9778-CI-2002