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Retrospective Data Collection Study in Patients With Macular Oedema Receiving OZURDEX®

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ClinicalTrials.gov Identifier: NCT02181530
Recruitment Status : Completed
First Posted : July 4, 2014
Results First Posted : May 25, 2015
Last Update Posted : May 25, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Macular Edema
Retinal Vein Occlusion
Intervention Other: No Intervention
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OZURDEX®
Hide Arm/Group Description Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Period Title: Overall Study
Started 43
Completed 43
Not Completed 0
Arm/Group Title OZURDEX®
Hide Arm/Group Description Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants
59.02  (13.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
17
  39.5%
Male
26
  60.5%
1.Primary Outcome
Title Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Hide Description BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved.
Time Frame Baseline, 7 to 12 weeks following the first OZURDEX® injection
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with data available at the time-point.
Arm/Group Title OZURDEX®
Hide Arm/Group Description:
Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.22  (0.22)
Change from Baseline at 7 to 12 weeks (n=27) 0.18  (0.25)
2.Secondary Outcome
Title Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye
Hide Description BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 2 lines or more indicates an improvement.
Time Frame Baseline, Up to 17 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title OZURDEX®
Hide Arm/Group Description:
Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
63
3.Secondary Outcome
Title Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye
Hide Description BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 3 lines or more indicates an improvement.
Time Frame Baseline, Up to 17 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title OZURDEX®
Hide Arm/Group Description:
Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
53
4.Secondary Outcome
Title Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Hide Description OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement
Time Frame Baseline, 7 to 12 weeks following the first OZURDEX® injection
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with data available at the given time-point.
Arm/Group Title OZURDEX®
Hide Arm/Group Description:
Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: μm
Baseline 695.12  (212.71)
Change from Baseline at 7 to 12 weeks (n=26) -355.08  (184.72)
5.Secondary Outcome
Title Time to Improvement of 2 Lines or More in BCVA in the Study Eye
Hide Description BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 2 or more lines is reported.
Time Frame Baseline, Up to 17 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with improvement of 2 lines or more in BCVA.
Arm/Group Title OZURDEX®
Hide Arm/Group Description:
Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: days
105.41  (184.50)
6.Secondary Outcome
Title Time to Improvement of 3 Lines or More in BCVA in the Study Eye
Hide Description BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 3 or more lines is reported.
Time Frame Baseline, Up to 17 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with improvement of 3 lines or more in BCVA.
Arm/Group Title OZURDEX®
Hide Arm/Group Description:
Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: days
100.48  (172.84)
7.Secondary Outcome
Title Time to OZURDEX® Re-Injection in the Study Eye
Hide Description [Not Specified]
Time Frame Up to 17 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had OZURDEX® re-injection.
Arm/Group Title OZURDEX®
Hide Arm/Group Description:
Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: days
223.00  (54.71)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OZURDEX®
Hide Arm/Group Description Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
All-Cause Mortality
OZURDEX®
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OZURDEX®
Affected / at Risk (%)
Total   0/43 (0.00%) 
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   29/43 (67.44%) 
Eye disorders   
Ocular hypertension   5/43 (11.63%) 
Conjunctival haemorrhage   11/43 (25.58%) 
Chemosis   4/43 (9.30%) 
Conjunctival hyperaemia   10/43 (23.26%) 
Cortical/nuclear cataract   4/43 (9.30%) 
Subcapsular cataract   2/43 (4.65%) 
Vitreous floaters   2/43 (4.65%) 
Eye pain   3/43 (6.98%) 
Investigations   
Increased intraocular pressure   12/43 (27.91%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02181530     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/RET/016
First Submitted: July 2, 2014
First Posted: July 4, 2014
Results First Submitted: April 10, 2015
Results First Posted: May 25, 2015
Last Update Posted: May 25, 2015