Clinical trial NCT02050828: The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema
Official title: A Phase 2, Randomized, Active-Controlled, Double-Masked, Multi-Center Study to Assess the Safety and Efficacy of Daily Subcutaneous AKB-9778 Administered for 3 Months, as Monotherapy or Adjunctive to Ranibizumab, in Subjects With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema (DME)
Lead sponsor: Aerpio Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-01-31
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of AKB-9778 administered as daily subcutaneous injections with and without monthly intravitreal injections of ranibizumab for 3 months in patients with diabetic macular edema.


Eligibility 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 in the study eye determined to be primarily the result of DME
* Definite retinal thickening due to diffuse DME involving the central macula in the study eye
* Central subfield thickness of at least 325 µm by sdOCT with presence of intraretinal fluid in the study eye
* ETDRS BCVA letter score ≤ 76 and ≥ 24 in the study eye

The following is an abbreviated list of exclusion criteria:

* Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening
* History of non infectious uveitis
* Decrease in visual acuity due to causes other than DME in the study eye
* History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):

  1. Prior pars plana vitrectomy
  2. Any ocular surgery within 3 months prior to Day 1
  3. YAG capsulotomy within 3 months prior to Day 1
  4. Panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Day 1 or anticipated need for PRP during the course of the study
  5. Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1
  6. Prior treatment with intravitreal anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1

Primary outcomes:
measure: Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST)
timeFrame: Month 3
Secondary outcomes:
measure: Mean change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
timeFrame: Month 3
Other outcomes:
Locations:
city: Pheonix
country: United States
state: Arizona
city: Pheonix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Arcadia
country: United States
state: California
city: Bakersfield
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Palm Desert
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Golden
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Stuart
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
city: Jackson
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Reno
country: United States
state: Nevada
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Florence
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Nashville
country: United States
state: Tennessee
city: Abilene
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Warrenton
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
Study officials:
References: