Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema
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ClinicalTrials.gov Identifier: NCT01702441 |
Recruitment Status :
Completed
First Posted : October 8, 2012
Last Update Posted : March 27, 2015
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Condition or disease | Intervention/treatment | Phase |
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Diabetic Macular Edema (DME) | Drug: Subcutaneous AKB-9778 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | December 2014 |
Arm | Intervention/treatment |
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Experimental: AKB-9778
Up to 4 dose levels of subcutaneous AKB-9778 will be evaluated. Doses will be administered daily for 28 days.
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Drug: Subcutaneous AKB-9778 |
- Incidence and severity of adverse events (AEs). [ Time Frame: 28 days ]
- Change from baseline in physical exams. [ Time Frame: 28 days ]
- Change from baseline in vital signs. [ Time Frame: 28 days ]
- Change from baseline in electrocardiograms (ECGs). [ Time Frame: 28 days ]
- Change from baseline in opthalmic exams. [ Time Frame: 28 days ]
- Change from baseline in clinical laboratory assay results. [ Time Frame: 28 days ]Blood chemistry, hematology and urinalysis.
- Pharmacokinetics of AKB-9778 [ Time Frame: Day 1 and Day 14 ]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 ]
- Change from baseline in best corrected visual acuity (BCVA). [ Time Frame: 28 days ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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%
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702441
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 |
Study Director: | Kevin Peters, MD | Aerpio Therapeutics |
Responsible Party: | Aerpio Therapeutics |
ClinicalTrials.gov Identifier: | NCT01702441 |
Other Study ID Numbers: |
AKB-9778-CI-2002 |
First Posted: | October 8, 2012 Key Record Dates |
Last Update Posted: | March 27, 2015 |
Last Verified: | March 2015 |
Macular Edema Edema Macular Degeneration |
Retinal Degeneration Retinal Diseases Eye Diseases |