A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Retinal Consultants of Arizona
• Collaborator: Allergan
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ophthalmic Solutions; Prednisolone acetate; Tetrahydrozoline

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.