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

Phase 2

Completed

• Conditions: Macular Edema; Diabetes Mellitus
• Interventions: Drug: Dexamethasone intravitreal implant; Drug: Steroid plus NSAID eye drop combination therapy

• Registration Number: NCT01673191
• Lead Sponsor: Retinal Consultants of Arizona

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-27
• Study Start: 2012-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-02
• Results First Submitted: 2017-02-20
• Results First Submitted QC: 2017-02-20
• Last Update Submitted: 2017-02-20
• Results First Posted: 2017-04-05
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OZURDEX intraocular implant	Dexamethasone intravitreal implant	OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg
Steroid plus NSAID eye drop combination therapy	Steroid plus NSAID eye drop combination therapy	NSAID eye drop: Acular LS Steriod eye drop: Pred Forte

Primary Outcome Measures

Name	Time	Method
Mean Change in Best Corrected Visual Acuity	3 months
Mean Change in Central Retinal Thickness	3 months
Mean Change in Intraocular Pressure	3 months

Trial Locations

Locations (1)

Retinal Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States