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

Diabetic Macular Edema (DME) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702441
• Other study ID #: AKB-9778-CI-2002
• 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

• Diabetic Macular Edema (DME)
• Edema
• Macular Edema

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