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

Retinal Consultants of Arizona

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus

Macular Edema

Treatments

Drug: Steroid plus NSAID eye drop combination therapy

Drug: Dexamethasone intravitreal implant

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01673191

RCA2012

Details and patient eligibility

About

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

Full description

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

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.