Trials / Completed
CompletedNCT02050828
The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 144 (actual)
- Sponsor
- Aerpio Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AKB-9778 | |
| DRUG | ranibizumab | |
| DRUG | Placebo | |
| DRUG | Sham |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2015-04-01
- Completion
- 2015-05-01
- First posted
- 2014-01-31
- Last updated
- 2017-03-16
Locations
39 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02050828. Inclusion in this directory is not an endorsement.