Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion

Retinal Vein Occlusion Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566526
• Other study ID #: MAF/AGN/OPH/RET/012
• Status: Completed
• Phase: N/A
• First received: March 27, 2012
• Last updated: March 27, 2013
• Start date: March 2012
• Est. completion date: June 2012

Study information

• Verified date: March 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

• Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Macular Edema
• Macular Oedema
• Retinal Vein Occlusion

Intervention

Drug:
• dexamethasone intravitreal implant 0.7 mg
OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to OZURDEX® Re-Injection in the Study Eye	The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.	Up to 12 Months	No
Secondary	Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye	BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart and is 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 has improved. Data are reported for the 7-12 week period following the last injection.	Baseline, 7 to 12 weeks following the last injection	No
Secondary	Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye	BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.	Baseline, Up to 12 Months	No
Secondary	Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye	BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.	Baseline, Up to 12 Months	No
Secondary	Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last 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. Data are reported for the 7-12 week period following the last injection.	Baseline, 7 to 12 weeks following the last injection	No
Secondary	Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye	BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.	Baseline, Up to 12 Months	No
Secondary	Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye	BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.	Baseline, Up to 12 Months	No