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

Primary Purpose

Diabetic Macular Edema (DME)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Subcutaneous AKB-9778

About this trial

This is an interventional treatment trial for Diabetic Macular Edema (DME)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AKB-9778

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events (AEs).

Change from baseline in physical exams.

Change from baseline in vital signs.

Change from baseline in electrocardiograms (ECGs).

Change from baseline in opthalmic exams.

Change from baseline in clinical laboratory assay results.

Blood chemistry, hematology and urinalysis.

Secondary Outcome Measures

Pharmacokinetics of AKB-9778

Maximum plasma drug concentration (Cmax). Area under the plasma concentration-time curve (AUC).

Change from baseline in optical tomography (OCT)-measured retinal thickness.

Change from baseline in best corrected visual acuity (BCVA).

Full Information

NCT ID

NCT01702441

First Posted

September 24, 2012

Last Updated

March 9, 2015

Sponsor

Aerpio Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01702441

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aerpio Therapeutics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema (DME)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AKB-9778

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Subcutaneous AKB-9778

Primary Outcome Measure Information:

Title

Incidence and severity of adverse events (AEs).

Time Frame

28 days

Title

Change from baseline in physical exams.

Time Frame

28 days

Title

Change from baseline in vital signs.

Time Frame

28 days

Title

Change from baseline in electrocardiograms (ECGs).

Time Frame

28 days

Title

Change from baseline in opthalmic exams.

Time Frame

28 days

Title

Change from baseline in clinical laboratory assay results.

Description

Blood chemistry, hematology and urinalysis.

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Pharmacokinetics of AKB-9778

Description

Maximum plasma drug concentration (Cmax). Area under the plasma concentration-time curve (AUC).

Time Frame

Day 1 and Day 14

Title

Change from baseline in optical tomography (OCT)-measured retinal thickness.

Time Frame

28 days

Title

Change from baseline in best corrected visual acuity (BCVA).

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kevin Peters, MD

Organizational Affiliation

Aerpio Therapeutics

Official's Role

Study Director

Facility Information:

City

Beverly Hills

State/Province

California

Country

United States

City

Winter Haven

State/Province

Florida

Country

United States

City

Baltimore

State/Province

Maryland

Country

United States

City

Boston

State/Province

Massachusetts

Country

United States

City

Charlotte

State/Province

North Carolina

Country

United States

City

Cincinnati

State/Province

Ohio

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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