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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Retinal Consultants of Arizona
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Retinal Consultants of Arizona
ClinicalTrials.gov Identifier:
NCT01673191
First received: August 22, 2012
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Macular Edema After Cataract Surgery in Patients With Diabetes Mellitus
Drug: Dexamethasone intravitreal implant
Drug: Steroid plus NSAID eye drop combination therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Retinal Consultants of Arizona:

Primary Outcome Measures:
  • Percentage of patients with significant decrease in OCT (e.g., 50-100 µm) following treatment with OZURDEX®. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673191

Locations
United States, Arizona
Retinal Consultants of Arizona Recruiting
Phoenix, Arizona, United States, 85014
Contact: Sarah Mobley    602-222-2221 ext 4152    smobley@retinalconsultantsaz.com   
Principal Investigator: Pravin Dugel, MD         
Sub-Investigator: Derek Kunimoto, MD         
Sub-Investigator: Edward Quinlan, MD         
Sub-Investigator: Jaime Gaitan, MD         
Sub-Investigator: David Goldenberg, MD         
Sub-Investigator: Karim Jamal, MD         
Sub-Investigator: Sachin Mehta, MD         
Sub-Investigator: Madhavi Kurli, MD         
Sponsors and Collaborators
Retinal Consultants of Arizona
Allergan
Investigators
Principal Investigator: Pravin U Dugel, MD Retinal Consultants of Arizona
  More Information

No publications provided

Responsible Party: Retinal Consultants of Arizona
ClinicalTrials.gov Identifier: NCT01673191     History of Changes
Other Study ID Numbers: RCA2012
Study First Received: August 22, 2012
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Macular Edema
Cataract
Capsule Opacification
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Lens Diseases
Anti-Inflammatory Agents, Non-Steroidal
Tetrahydrozoline
Ophthalmic Solutions
Dexamethasone
Dexamethasone acetate
Prednisolone acetate
Dexamethasone 21-phosphate
BB 1101
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 21, 2014