drugset / Trial / NCT01565148
A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study)
Phase 2
Terminated
185 enrolled
Johns Hopkins University
Juvenile Diabetes Research Foundation · collabiCo Therapeutics Inc. · collab
RandomizedFactorialOpen-labelTreatment
Summary
* To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation * To assess the change in visual acuity and retinal thickness on optical coherence tomography (OCT) from baseline to month 8 and month 12
Timeline
- Start
- 2012-02
- Primary completion
- 2014-02
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |
| Subject | iCo-007 | Unknown | 350 ug | Intravitreal |
| Subject | iCo-007 | Unknown | 700 ug | Intravitreal |