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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-12-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Macular Edema Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OZURDEX intraocular implant

OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg

Group Type EXPERIMENTAL

Dexamethasone intravitreal implant

Intervention Type DRUG

Steroid plus NSAID eye drop combination therapy

NSAID eye drop: Acular LS Steriod eye drop: Pred Forte

Group Type ACTIVE_COMPARATOR

Steroid plus NSAID eye drop combination therapy

Intervention Type DRUG

Interventions

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Dexamethasone intravitreal implant

Intervention Type DRUG

Steroid plus NSAID eye drop combination therapy

Intervention Type DRUG

Other Intervention Names

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OZURDEX Acular LS and Pred Forte

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No