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Trial record 57 of 81 for:    CRVO - Central Retinal Vein Occlusion

Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)

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ClinicalTrials.gov Identifier: NCT01568021
Recruitment Status : Completed
First Posted : April 2, 2012
Results First Posted : February 10, 2015
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Retinal Vein Occlusion
Macular Edema
Intervention Other: No Intervention
Enrollment 100
Recruitment Details  
Pre-assignment Details This was a Post-Marketing Surveillance Study of OZURDEX®. 100 participants who received OZURDEX® as standard of care in clinical practice were enrolled in the study. Only 99 participants who had data recorded at Baseline and Follow-up were included in the analyses.
Arm/Group Title OZURDEX®
Hide Arm/Group Description Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
Period Title: Overall Study
Started 99
Completed 83
Not Completed 16
Arm/Group Title OZURDEX®
Hide Arm/Group Description Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
Overall Number of Baseline Participants 99
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants
< 45 years 1
45 to 65 years 24
> 65 years 74
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants
Female
41
  41.4%
Male
58
  58.6%
1.Primary Outcome
Title Time to First Re-treatment
Hide Description Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants with complete data.
Arm/Group Title OZURDEX®
Hide Arm/Group Description:
Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
Overall Number of Participants Analyzed 99
Median (95% Confidence Interval)
Unit of Measure: days
157
(134 to 189)
2.Secondary Outcome
Title Change From Baseline in Best Corrected Visual Acuity (BCVA) Score
Hide Description BCVA was measured in the study eye using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision improved.
Time Frame Baseline, Weeks 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with complete data at the given time-point.
Arm/Group Title OZURDEX®
Hide Arm/Group Description:
Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
Overall Number of Participants Analyzed 99
Mean (Standard Deviation)
Unit of Measure: letters
Baseline 52.8  (15.61)
Change from Baseline at Week 12 (n= 68) 8.5  (13.16)
Change from Baseline at Week 24 (n= 75) 6.9  (13.01)
Change from Baseline at Week 48 (n= 75) 2.5  (18.61)
3.Secondary Outcome
Title Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Hide Description Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement.
Time Frame Baseline, Weeks 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with complete data at the given time-point.
Arm/Group Title OZURDEX®
Hide Arm/Group Description:
Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
Overall Number of Participants Analyzed 99
Mean (Standard Deviation)
Unit of Measure: microns
Baseline (n- 93) 535.2  (166.75)
Change from Baseline at Week 12 (n= 63) -181.3  (198.25)
Change from Baseline at Week 24 (n= 69) -160.4  (185.45)
Change from Baseline at Week 48 (n= 70) -147.7  (191.63)
Time Frame [Not Specified]
Adverse Event Reporting Description Only Treatment-Related Adverse Events were collected in this Post Marketing Surveillance Study.
 
Arm/Group Title OZURDEX®
Hide Arm/Group Description Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
All-Cause Mortality
OZURDEX®
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OZURDEX®
Affected / at Risk (%)
Total   1/99 (1.01%) 
Eye disorders   
Endophthalmitis  1  1/99 (1.01%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OZURDEX®
Affected / at Risk (%)
Total   26/99 (26.26%) 
Eye disorders   
Ocular hypertension  1  26/99 (26.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01568021     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/RET/007
First Submitted: March 29, 2012
First Posted: April 2, 2012
Results First Submitted: January 27, 2015
Results First Posted: February 10, 2015
Last Update Posted: February 10, 2015