This study will 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).
Study Type
OBSERVATIONAL
Enrollment
87
Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.
Unnamed facility
Münster, Germany
Time to OZURDEX® Re-injection
Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.
Time frame: Up to 12 months
Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement.
Time frame: Baseline, 7 to 12 weeks following the last injection
Percentage of Patients With an Increase of 2 Lines or More in BCVA
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.
Time frame: Baseline, Up to 12 months
Percentage of Patients With an Increase of 3 Lines or More in BCVA
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.
Time frame: Baseline, Up to 12 months
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement.
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Time frame: Baseline, 7 to 12 weeks following the last injection
Time to Improvement of 2 Lines or More in BCVA
Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).
Time frame: Baseline, Up to 12 months
Time to Improvement of 3 Lines or More in BCVA
Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).
Time frame: Baseline, Up to 12 months