An observational study in Retinal Vein Occlusion and Macular Oedema, sponsored by Allergan. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-27.
Sponsored by Allergan · Observational
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.
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This study's enrollment of 26 is below the median of 97 across 163 observational studies indexed under Macular Edema.
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Patients with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of the Belgium Medical Needs Program.
Exclusion Criteria:
OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
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.
Also known as: OZURDEX®
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.
Time frame: Up to 12 Months
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.
Time frame: Baseline, 7 to 12 weeks following the last injection
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.
Time frame: Baseline, Up to 12 Months
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.
Time frame: Baseline, Up to 12 Months
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.
Time frame: Baseline, 7 to 12 weeks following the last injection
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.
Time frame: Baseline, Up to 12 Months
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.
Time frame: Baseline, Up to 12 Months
| Milestone | Patients Previously Treated With OZURDEX® |
|---|---|
| Started | 26 |
| Completed | 26 |
| Not completed | 0 |
The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.
| Days | Patients Previously Treated With OZURDEX® |
|---|---|
| Time to OZURDEX® Re-Injection in the Study Eye | 143.65 ± 42.95 |
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.
| Letters | Patients Previously Treated With OZURDEX® |
|---|---|
| Baseline | 61.75 ± 29.02 |
| Change from Baseline 7-12 Wks After Last Injection | -5.00 ± 45.28 |
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.
| Percent of Participants | Patients Previously Treated With OZURDEX® |
|---|---|
| Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye | 50.0 |
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.
| Percent of Participants | Patients Previously Treated With OZURDEX® |
|---|---|
| Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye | 42.3 |
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.
| Micrometers (µm) | Patients Previously Treated With OZURDEX® |
|---|---|
| Baseline | 665.00 ± 287.84 |
| Change from Baseline 7-12 Wks After Last Injection | -382.17 ± 285.36 |
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.
| Days | Patients Previously Treated With OZURDEX® |
|---|---|
| Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye | 41.0 ± 41.49 |
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.
| Days | Patients Previously Treated With OZURDEX® |
|---|---|
| Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye | 41.0 ± 45.46 |
Collected over All adverse events (AEs) related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Previously Treated With OZURDEX® | — | 0/26 (0%) | 20/26 (76.9%) |
| Event | Patients Previously Treated With OZURDEX® |
|---|---|
| Lenticular OpacitiesEye disorders | 5/26 |
| Ocular HypertensionEye disorders | 5/26 |
| Intraocular Pressure IncreasedEye disorders | 4/26 |
| CataractEye disorders | 3/26 |
| Cataract OperationEye disorders | 3/26 |
| Eye Laser SurgeryEye disorders | 3/26 |
| Macular FibrosisEye disorders | 2/26 |
| Visual ImpairmentEye disorders | 2/26 |
| Age, Customized(Participants) | Patients Previously Treated With OZURDEX® |
|---|---|
| 41 to 50 years | 3 |
| 51 to 60 years | 10 |
| 61 to 70 years | 4 |
| 71 to 80 years | 8 |
| 81 to 90 years | 1 |
| Sex: Female, Male(Participants) | Patients Previously Treated With OZURDEX® |
|---|---|
| Female | 14 |
| Male | 12 |
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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