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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aerpio Therapeutics
ClinicalTrials.gov Identifier:
NCT01702441
First received: September 24, 2012
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Diabetic Macular Edema (DME)
Drug: Subcutaneous AKB-9778
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Aerpio Therapeutics:

Primary Outcome Measures:
  • Incidence and severity of adverse events (AEs). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change from baseline in physical exams. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change from baseline in vital signs. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change from baseline in electrocardiograms (ECGs). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change from baseline in opthalmic exams. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change from baseline in clinical laboratory assay results. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Blood chemistry, hematology and urinalysis.


Secondary Outcome Measures:
  • Pharmacokinetics of AKB-9778 [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: Yes ]
    Maximum plasma drug concentration (Cmax). Area under the plasma concentration-time curve (AUC).

  • Change from baseline in optical tomography (OCT)-measured retinal thickness. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline in best corrected visual acuity (BCVA). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702441

Locations
United States, California
Beverly Hills, California, United States
United States, Florida
Winter Haven, Florida, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Sponsors and Collaborators
Aerpio Therapeutics
Investigators
Study Director: Kevin Peters, MD Aerpio Therapeutics
  More Information

No publications provided

Responsible Party: Aerpio Therapeutics
ClinicalTrials.gov Identifier: NCT01702441     History of Changes
Other Study ID Numbers: AKB-9778-CI-2002
Study First Received: September 24, 2012
Last Updated: August 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 22, 2014