Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2013 |
| Start Date: | March 2012 |
| End Date: | January 2015 |
| Contact: | Allergan Inc. |
| Email: | clinicaltrials@allergan.com |
This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal
implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular
edema (DME).
Inclusion Criteria:
- Diagnosis of type 1 or 2 diabetes mellitus
- Diagnosis of macular edema
- Visual acuity between 20/200 to 20/40
Exclusion Criteria:
- Eye surgery to the study eye within 3 months
- Use of Ozurdex® within 9 months
- Any active ocular inflammation and infection
- Diagnosis of glaucoma
- Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic
use (e.g., Avastin®) within 6 months
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