Macular Edema After Cataract Surgery in Patients With Diabetes Mellitus Clinical Trial
Official title:
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
| Verified date | March 2014 |
| Source | Retinal Consultants of Arizona |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery. The objective of this study is to assess the safety and efficacy of the OZURDEX® intraocular implant in patients with diabetes mellitus, who develop macular edema after cataract surgery.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Retinal Consultants of Arizona | Phoenix | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Retinal Consultants of Arizona | Allergan |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of patients with significant decrease in OCT (e.g., 50-100 µm) following treatment with OZURDEX®. | 3 months | No |