Clinical Trials/NCT01702441

NCT01702441

Completed

Phase 1

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

Aerpio Therapeutics0 sites24 target enrollmentSeptember 2012

ConditionsDiabetic Macular Edema (DME)

InterventionsSubcutaneous AKB-9778

DrugsSubcutaneous AKB-9778

Overview

Phase: Phase 1
Intervention: Subcutaneous AKB-9778
Conditions: Diabetic Macular Edema (DME)
Sponsor: Aerpio Therapeutics
Enrollment: 24
Primary Endpoint: Incidence and severity of adverse events (AEs).
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

December 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Aerpio Therapeutics

Responsible Party

Sponsor

Eligibility 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):
•Panretinal scatter photocoagulation (PRP) or focal laser within 12 weeks prior to Screening
•Prior pars plana vitrectomy within 12 weeks prior to Screening
•Any ocular surgery within 12 weeks prior to Screening
•YAG capsulotomy within 7 days prior to Screening
•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

Arms & Interventions

AKB-9778

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

Intervention: Subcutaneous AKB-9778

Outcomes

Primary Outcomes

Incidence and severity of adverse events (AEs).

Time Frame: 28 days

Change from baseline in physical exams.

Time Frame: 28 days

Change from baseline in vital signs.

Time Frame: 28 days

Change from baseline in electrocardiograms (ECGs).

Time Frame: 28 days

Change from baseline in opthalmic exams.

Time Frame: 28 days

Change from baseline in clinical laboratory assay results.

Time Frame: 28 days

Blood chemistry, hematology and urinalysis.

Secondary Outcomes

Pharmacokinetics of AKB-9778(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)