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

Completed · Phase 1/Phase 2

Conditions studied: Diabetic Macular Edema (DME)

In brief

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).

Key facts

Study ID

NCT01702441

Run by

Aerpio Therapeutics

People needed

24

Starts

2012-09-01

Expected to finish

2014-12-01

Last updated by the study team

2015-03-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — Winter Haven, Florida, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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