The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema
TIME-2
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
1 other identifier
interventional
144
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2014
Shorter than P25 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 29, 2014
CompletedFirst Posted
Study publicly available on registry
January 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMarch 16, 2017
March 1, 2017
1.2 years
January 29, 2014
March 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST)
Month 3
Secondary Outcomes (1)
Mean change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
Month 3
Study Arms (3)
AKB-9778 15 mg BID monotherapy
EXPERIMENTALSubcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus monthly sham intravitreal injection for 3 months.
AKB-9778 15 mg BID + ranibizumab 0.3 mg
EXPERIMENTALSubcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
ranibizumab 0.3 mg monotherapy
ACTIVE COMPARATORPlacebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Prior pars plana vitrectomy
- Any ocular surgery within 3 months prior to Day 1
- YAG capsulotomy within 3 months prior to Day 1
- 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
- Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1
- Prior treatment with intravitreal anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Pheonix, Arizona, 85014, United States
Unknown Facility
Pheonix, Arizona, 85020, United States
Unknown Facility
Tucson, Arizona, 85704, United States
Unknown Facility
Arcadia, California, 91007, United States
Unknown Facility
Bakersfield, California, 93309, United States
Unknown Facility
Beverly Hills, California, 90211, United States
Unknown Facility
Palm Desert, California, 92260, United States
Unknown Facility
Sacramento, California, 95819, United States
Unknown Facility
Santa Ana, California, 92705, United States
Unknown Facility
Santa Barbara, California, 93103, United States
Unknown Facility
Golden, Colorado, 80401, United States
Unknown Facility
Boynton Beach, Florida, 33426, United States
Unknown Facility
Fort Lauderdale, Florida, 33334, United States
Unknown Facility
Fort Myers, Florida, 33912, United States
Unknown Facility
Miami, Florida, 33126, United States
Unknown Facility
Sarasota, Florida, 34239, United States
Unknown Facility
Stuart, Florida, 34994, United States
Unknown Facility
Winter Haven, Florida, 33880, United States
Unknown Facility
Baltimore, Maryland, 21287, United States
Unknown Facility
Jackson, Michigan, 49202, United States
Unknown Facility
Omaha, Nebraska, 68198, United States
Unknown Facility
Reno, Nevada, 89502, United States
Unknown Facility
Rochester, New York, 14620, United States
Unknown Facility
Charlotte, North Carolina, 28210, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Florence, South Carolina, 29501, United States
Unknown Facility
Rapid City, South Dakota, 57701, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Abilene, Texas, 79606, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Fort Worth, Texas, 76102, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
McAllen, Texas, 78503, United States
Unknown Facility
San Antonio, Texas, 78240, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
Unknown Facility
Warrenton, Virginia, 20186, United States
Unknown Facility
Bellevue, Washington, 98004, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2014
First Posted
January 31, 2014
Study Start
January 1, 2014
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
March 16, 2017
Record last verified: 2017-03