Phase 2
Completed N=37
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
Source: ClinicalTrials.gov NCT01673191 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Mean Change in Best Corrected Visual Acuity — 0.3; 0.33 logMAR units
Summary
There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Best Corrected Visual Acuity |
0.34; 0.21 | — |
| PRIMARY Mean Change in Central Retinal Thickness |
318.7; 341.1 | — |
| PRIMARY Mean Change in Intraocular Pressure |
14.9; 14.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has diagnosis of Diabetes Mellitus, Type I or II.
- Patient has experienced the development of macular edema following cataract surgery in at least one eye.
- Patient has had cataract surgery within 90 days prior to the screening visit.
Exclusion Criteria
- Patient has other significant ocular disease in study eye, including glaucoma.
- Patient has any active infection in the study eye.
- Patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure, uncontrolled diabetes mellitus).
- Patient has experienced a significant increase in intraocular pressure following a prior treatment with topical or intravitreal steroidal medication.
- Patient has received the OZURDEX® implant before in the study eye.
Data sourced from ClinicalTrials.gov (NCT01673191). 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. Informational only — not medical advice.