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

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Diabetic Macular Edema (DME)	Drug: Subcutaneous AKB-9778	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	September 2012
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	December 2014

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. Incidence and severity of adverse events (AEs). [ Time Frame: 28 days ]
2. Change from baseline in physical exams. [ Time Frame: 28 days ]
3. Change from baseline in vital signs. [ Time Frame: 28 days ]
4. Change from baseline in electrocardiograms (ECGs). [ Time Frame: 28 days ]
5. Change from baseline in opthalmic exams. [ Time Frame: 28 days ]
6. Change from baseline in clinical laboratory assay results. [ Time Frame: 28 days ]
   Blood chemistry, hematology and urinalysis.

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Aerpio Therapeutics
ClinicalTrials.gov Identifier:	NCT01702441 History of Changes
Other Study ID Numbers:	AKB-9778-CI-2002
First Posted:	October 8, 2012
Last Update Posted:	March 27, 2015
Last Verified:	March 2015

Additional relevant MeSH terms:

Edema; Macular Edema; Signs and Symptoms; Macular Degeneration	Retinal Degeneration; Retinal Diseases; Eye Diseases