Phase 2
N=363
Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT01492400 ↗Enrolled (actual)
363
Serious AEs
22.3%
Results posted
Jan 2015
Primary outcome: Primary: Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye — 60.2; 60.4; 4.34; 7.60 Letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dexamethasone Intravitreal Implant (Drug); ranibizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye |
60.2; 60.4; 4.34; 7.60 | — |
| SECONDARY Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye |
465.1; 471.2; -173.9; -163.5 | — |
| SECONDARY Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA) |
19.2; 18.9; -16.1; -12.0 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01492400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.