Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema
This study has been completed.
Sponsor:
Aerpio Therapeutics
Information provided by (Responsible Party):
Aerpio Therapeutics
ClinicalTrials.gov Identifier:
NCT01702441
First received: September 24, 2012
Last updated: December 9, 2014
Last verified: December 2014
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Macular Edema (DME) |
Drug: Subcutaneous AKB-9778 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Aerpio Therapeutics:
Primary Outcome Measures:
- Incidence and severity of adverse events (AEs). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Change from baseline in physical exams. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Change from baseline in vital signs. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Change from baseline in electrocardiograms (ECGs). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Change from baseline in opthalmic exams. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Change from baseline in clinical laboratory assay results. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Blood chemistry, hematology and urinalysis.
Secondary Outcome Measures:
- Pharmacokinetics of AKB-9778 [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: Yes ]Maximum plasma drug concentration (Cmax). Area under the plasma concentration-time curve (AUC).
- Change from baseline in optical tomography (OCT)-measured retinal thickness. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Change from baseline in best corrected visual acuity (BCVA). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 24 |
| Study Start Date: | September 2012 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AKB-9778
Up to 4 dose levels of subcutaneous AKB-9778 will be evaluated. Doses will be administered daily for 28 days.
|
Drug: Subcutaneous AKB-9778 |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702441
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702441
Locations
| United States, California | |
| Beverly Hills, California, United States | |
| United States, Florida | |
| Winter Haven, Florida, United States | |
| United States, Maryland | |
| Baltimore, Maryland, United States | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States | |
| United States, Ohio | |
| Cincinnati, Ohio, United States | |
Sponsors and Collaborators
Aerpio Therapeutics
Investigators
| Study Director: | Kevin Peters, MD | Aerpio Therapeutics |
More Information
No publications provided
| Responsible Party: | Aerpio Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01702441 History of Changes |
| Other Study ID Numbers: | AKB-9778-CI-2002 |
| Study First Received: | September 24, 2012 |
| Last Updated: | December 9, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Macular Edema Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases |
ClinicalTrials.gov processed this record on March 03, 2015