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

Phase 1

Completed

• Conditions: Diabetic Macular Edema (DME)
• Interventions: Drug: Subcutaneous AKB-9778

• Registration Number: NCT01702441
• Lead Sponsor: Aerpio Therapeutics

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-10-05
• Study First Posted: 2012-10-08
• Primary Completion: 2013-09
• Study Completion: 2014-12
• Status Verified: 2015-03
• Disposition First Submitted: 2015-03-09
• Disposition First Submitted QC: 2015-03-09
• Last Update Submitted: 2015-03-09
• Disposition First Posted: 2015-03-27
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AKB-9778	Subcutaneous AKB-9778	Up to 4 dose levels of subcutaneous AKB-9778 will be evaluated. Doses will be administered daily for 28 days.

Primary Outcome Measures

Name	Time	Method
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.	28 days	Blood chemistry, hematology and urinalysis.

Secondary Outcome Measures

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