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Completed

NCT Number: NCT01702441

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

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).

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Key information

Conditions

Diabetic Macular Edema (DME)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beverly Hills, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subcutaneous AKB-9778

Drug

Primary outcomes

  1. Incidence and severity of adverse events (AEs).

    Time frame: 28 days

  2. Change from baseline in physical exams.

    Time frame: 28 days

  3. Change from baseline in vital signs.

    Time frame: 28 days

  4. Change from baseline in electrocardiograms (ECGs).

    Time frame: 28 days

  5. Change from baseline in opthalmic exams.

    Time frame: 28 days

  6. Change from baseline in clinical laboratory assay results.

    Time frame: 28 days

    Blood chemistry, hematology and urinalysis.

Secondary outcomes

  1. Pharmacokinetics of AKB-9778

    Time frame: Day 1 and Day 14

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

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

    Time frame: 28 days

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

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Aerpio Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 8, 2012
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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