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

NCT01702441 | Completed Phase 1 DMC

• 1 other identifier: AKB-9778-CI-2002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

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).

Conditions

Diabetic Macular Edema (DME)

Outcome Measures

Primary Outcomes (6)

• Incidence and severity of adverse events (AEs).

  28 days

• Change from baseline in physical exams.

  28 days

• Change from baseline in vital signs.

  28 days

• Change from baseline in electrocardiograms (ECGs).

  28 days

• Change from baseline in opthalmic exams.

  28 days

• Change from baseline in clinical laboratory assay results.

  Blood chemistry, hematology and urinalysis.

  28 days

Secondary Outcomes (3)

• 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

Study Arms (1)

AKB-9778

EXPERIMENTAL

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

Drug: Subcutaneous AKB-9778

Interventions

Subcutaneous AKB-9778 DRUG

AKB-9778

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hemoglobin A1C (HbA1C) ≥ 11.5%
• 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

Sponsors & Collaborators

• Aerpio Therapeutics: lead

Study Sites (6)

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Winter Haven, Florida, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Study Officials

• Kevin Peters, MD

  Aerpio Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: October 8, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2014
• Last Updated: March 27, 2015

Record last verified: 2015-03

Locations

US (6)