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

February 20, 2017 updated by: Retinal Consultants of Arizona
There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Consultants of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OZURDEX intraocular implant
OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg
Drug: Dexamethasone intravitreal implant
Other Names:
  • OZURDEX
Active Comparator: Steroid plus NSAID eye drop combination therapy
NSAID eye drop: Acular LS Steriod eye drop: Pred Forte
Drug: Steroid plus NSAID eye drop combination therapy
Other Names:
  • Acular LS and Pred Forte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Change in Best Corrected Visual Acuity
Time Frame: 1 months
1 months
Mean Change in Best Corrected Visual Acuity
Time Frame: 2 months
2 months
Mean Change in Best Corrected Visual Acuity
Time Frame: 3 months
3 months
Mean Change in Central Retinal Thickness
Time Frame: 1 month
1 month
Mean Change in Central Retinal Thickness
Time Frame: 2 months
2 months
Mean Change in Central Retinal Thickness
Time Frame: 3 months
3 months
Mean Change in Intraocular Pressure
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Retinal Consultants of Arizona

Collaborators

Allergan

Investigators

  • Principal Investigator: Pravin U Dugel, MD, Retinal Consultants of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 22, 2012

First Submitted That Met QC Criteria

August 22, 2012

First Posted (Estimate)

August 27, 2012

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCA2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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