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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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Retinal Consultants of Arizona
ClinicalTrials.gov Identifier:
NCT01673191
First received: August 22, 2012
Last updated: February 20, 2017
Last verified: February 2017
Results First Received: February 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Macular Edema
Diabetes Mellitus
Interventions: Drug: Dexamethasone intravitreal implant
Drug: Steroid plus NSAID eye drop combination therapy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
OZURDEX Intraocular Implant

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

Dexamethasone intravitreal implant

Steroid Plus NSAID Eye Drop Combination Therapy

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

Steroid plus NSAID eye drop combination therapy


Participant Flow:   Overall Study
    OZURDEX Intraocular Implant   Steroid Plus NSAID Eye Drop Combination Therapy
STARTED   26   11 
COMPLETED   26   11 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DEX IMPLANT ARM Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
Topical Steroid/NSAID ARM Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
Total Total of all reporting groups

Baseline Measures
   DEX IMPLANT ARM   Topical Steroid/NSAID ARM   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   11   37 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 26   11   37 
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      12  46.2%      4  36.4%      16  43.2% 
>=65 years      14  53.8%      7  63.6%      21  56.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 26   11   37 
   67.1  (7.6)   68  (8.4)   67.4  (7.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 26   11   37 
Female      14  53.8%      6  54.5%      20  54.1% 
Male      12  46.2%      5  45.5%      17  45.9% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed 
[Units: Participants]
 26   11   37 
United States   26   11   37 
Best Corrected Visual Acuity [1] 
[Units: logMAR units]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 26   11   37 
   0.49  (0.40)   0.32  (0.22)   0.44  (0.36) 
[1] logMAR
Central Retinal Thickness [1] 
[Units: Micrometers]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 26   11   37 
   402.2  (149.8)   403.5  (156.2)   402.5  (149.5) 
[1] Based on spectral domain optical coherence tomography (SD-OCT)
Intraocular Pressure 
[Units: Millimeters of mercury (mm Hg)]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 26   11   37 
   13.7  (2.8)   14.4  (2.5)   13.9  (2.7) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in Best Corrected Visual Acuity   [ Time Frame: 1 months ]

2.  Primary:   Mean Change in Best Corrected Visual Acuity   [ Time Frame: 2 months ]

3.  Primary:   Mean Change in Best Corrected Visual Acuity   [ Time Frame: 3 months ]

4.  Primary:   Mean Change in Central Retinal Thickness   [ Time Frame: 1 month ]

5.  Primary:   Mean Change in Central Retinal Thickness   [ Time Frame: 2 months ]

6.  Primary:   Mean Change in Central Retinal Thickness   [ Time Frame: 3 months ]

7.  Primary:   Mean Change in Intraocular Pressure   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of our study include a small sample size and short-term follow up. Additional studies are needed to determine whether combination therapy with other treatments would be beneficial to patients.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Pravin Dugel
Organization: Retinal Consultants of Arizona
phone: 602-222-2221
e-mail: PDugel@gmail.com



Responsible Party: Retinal Consultants of Arizona
ClinicalTrials.gov Identifier: NCT01673191     History of Changes
Other Study ID Numbers: RCA2012
Study First Received: August 22, 2012
Results First Received: February 20, 2017
Last Updated: February 20, 2017