Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-01

Study Completion Date

2009-12-01

Brief Summary

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The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

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Detailed Description

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Conditions

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Diabetic Macular Edema Vitrectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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700 µg Dexamethasone Implant

700 µg dexamethasone implant in the study eye at Day 1

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.

Interventions

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Dexamethasone

700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.

Intervention Type DRUG

Other Intervention Names

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Posurdex® OZURDEX®

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older with diabetic macular edema
* History of vitrectomy
* Central retinal thickness ≥ 275 µm
* Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye

Exclusion Criteria

* Known anticipated need for ocular surgery during the study period
* History of glaucoma or current high eye pressure requiring more than 1 medication
* Uncontrolled systemic disease
* Known allergy to the study medication
* Known steroid-responder
* Use of systemic steroids
* Female subjects that are pregnant, nursing or planning a pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No