Clinical trial NCT01702441: Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Macular Edema (DME)
Lead sponsor: Aerpio Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-10-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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):

  1. Panretinal scatter photocoagulation (PRP) or focal laser within 12 weeks prior to Screening
  2. Prior pars plana vitrectomy within 12 weeks prior to Screening
  3. Any ocular surgery within 12 weeks prior to Screening
  4. YAG capsulotomy within 7 days prior to Screening
  5. 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

Primary outcomes:
measure: Incidence and severity of adverse events (AEs).
timeFrame: 28 days
measure: Change from baseline in physical exams.
timeFrame: 28 days
measure: Change from baseline in vital signs.
timeFrame: 28 days
measure: Change from baseline in electrocardiograms (ECGs).
timeFrame: 28 days
measure: Change from baseline in opthalmic exams.
timeFrame: 28 days
measure: Change from baseline in clinical laboratory assay results.
timeFrame: 28 days
Secondary outcomes:
measure: Pharmacokinetics of AKB-9778
timeFrame: Day 1 and Day 14
measure: Change from baseline in optical tomography (OCT)-measured retinal thickness.
timeFrame: 28 days
measure: Change from baseline in best corrected visual acuity (BCVA).
timeFrame: 28 days
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Winter Haven
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
Study officials:
affiliation: Aerpio Therapeutics
name: Kevin Peters, MD
role: STUDY_DIRECTOR
References: