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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01702441

Enrollment

Registered

2012-10-08

Start date

2012-09-30

Completion date

2014-12-31

Last updated

2015-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema (DME)

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).

Interventions

DRUGSubcutaneous AKB-9778

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in clinical laboratory assay results.	28 days	Blood chemistry, hematology and urinalysis.
Change from baseline in vital signs.	28 days	—
Change from baseline in electrocardiograms (ECGs).	28 days	—
Change from baseline in opthalmic exams.	28 days	—
Incidence and severity of adverse events (AEs).	28 days	—
Change from baseline in physical exams.	28 days	—

Secondary

Measure	Time frame	Description
Change from baseline in optical tomography (OCT)-measured retinal thickness.	28 days	—
Change from baseline in best corrected visual acuity (BCVA).	28 days	—
Pharmacokinetics of AKB-9778	Day 1 and Day 14	Maximum plasma drug concentration (Cmax). Area under the plasma concentration-time curve (AUC).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026