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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

Tracking Information
First Submitted Date July 2, 2014
First Posted Date July 4, 2014
Results First Submitted Date April 10, 2015
Results First Posted Date May 25, 2015
Last Update Posted Date May 25, 2015
Study Start Date July 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2015)
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, 7 to 12 weeks following the first OZURDEX® injection ]
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.
Original Primary Outcome Measures
 (submitted: July 2, 2014)
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, 12 Weeks ]
Change History Complete list of historical versions of study NCT02181530 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 21, 2015)
  • Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye [ Time Frame: Baseline, Up to 17 Months ]
    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.
  • Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye [ Time Frame: Baseline, Up to 17 Months ]
    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.
  • Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, 7 to 12 weeks following the first OZURDEX® injection ]
    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 to Improvement of 2 Lines or More in BCVA in the Study Eye [ Time Frame: Baseline, Up to 17 Months ]
    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 to Improvement of 3 Lines or More in BCVA in the Study Eye [ Time Frame: Baseline, Up to 17 Months ]
    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 to OZURDEX® Re-Injection in the Study Eye [ Time Frame: Up to 17 Months ]
Original Secondary Outcome Measures
 (submitted: July 2, 2014)
  • Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye [ Time Frame: Baseline, Up to 17 Months ]
  • Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye [ Time Frame: Baseline, Up to 17 Months ]
  • Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, Up to 17 Months ]
  • Time to Improvement of 2 Lines or More in BCVA in the Study Eye [ Time Frame: Baseline, Up to 17 Months ]
  • Time to Improvement of 3 Lines or More in BCVA in the Study Eye [ Time Frame: Baseline, Up to 17 Months ]
  • Time to OZURDEX® Re-Injection in the Study Eye [ Time Frame: Up to 17 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retrospective Data Collection Study in Patients With Macular Oedema Receiving OZURDEX®
Official Title Not Provided
Brief Summary This study will use retrospective data to evaluate the safety and efficacy of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as part of this study.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of routine clinical practice.
Condition
  • Macular Edema
  • Retinal Vein Occlusion
Intervention Other: No Intervention
No treatment (intervention) is being administered as part of this study.
Study Groups/Cohorts OZURDEX®
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.
Intervention: Other: No Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 9, 2014)
43
Original Estimated Enrollment
 (submitted: July 2, 2014)
60
Actual Study Completion Date October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO)
  • Received at least one injection of OZURDEX® in the study eye

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02181530
Other Study ID Numbers MAF/AGN/OPH/RET/016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Allergan
Study Sponsor Allergan
Collaborators Not Provided
Investigators
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date May 2015