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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01673191
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Macular Edema Diabetes Mellitus Drug: Dexamethasone intravitreal implant Drug: Steroid plus NSAID eye drop combination therapy Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
Study Start Date : November 2012
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Acular LS and Pred Forte


Outcome Measures

Primary Outcome Measures :
  1. Mean Change in Best Corrected Visual Acuity [ Time Frame: 1 months ]
  2. Mean Change in Best Corrected Visual Acuity [ Time Frame: 2 months ]
  3. Mean Change in Best Corrected Visual Acuity [ Time Frame: 3 months ]
  4. Mean Change in Central Retinal Thickness [ Time Frame: 1 month ]
  5. Mean Change in Central Retinal Thickness [ Time Frame: 2 months ]
  6. Mean Change in Central Retinal Thickness [ Time Frame: 3 months ]
  7. Mean Change in Intraocular Pressure [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673191


Locations
United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
Sponsors and Collaborators
Retinal Consultants of Arizona
Allergan
Investigators
Principal Investigator: Pravin U Dugel, MD Retinal Consultants of Arizona
More Information

Responsible Party: Retinal Consultants of Arizona
ClinicalTrials.gov Identifier: NCT01673191     History of Changes
Other Study ID Numbers: RCA2012
First Posted: August 27, 2012    Key Record Dates
Results First Posted: April 5, 2017
Last Update Posted: April 5, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Macular Edema
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Prednisolone acetate
Dexamethasone
Tetrahydrozoline
BB 1101
Ophthalmic Solutions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions