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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01702441
Other study ID # AKB-9778-CI-2002
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 24, 2012
Last updated March 9, 2015
Start date September 2012
Est. completion date December 2014

Study information

Verified date March 2015
Source Aerpio Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Subcutaneous AKB-9778


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aerpio Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of adverse events (AEs). 28 days Yes
Primary Change from baseline in physical exams. 28 days Yes
Primary Change from baseline in vital signs. 28 days Yes
Primary Change from baseline in electrocardiograms (ECGs). 28 days Yes
Primary Change from baseline in opthalmic exams. 28 days Yes
Primary Change from baseline in clinical laboratory assay results. Blood chemistry, hematology and urinalysis. 28 days Yes
Secondary Pharmacokinetics of AKB-9778 Maximum plasma drug concentration (Cmax). Area under the plasma concentration-time curve (AUC). Day 1 and Day 14 Yes
Secondary Change from baseline in optical tomography (OCT)-measured retinal thickness. 28 days No
Secondary Change from baseline in best corrected visual acuity (BCVA). 28 days Yes
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