A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)

Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445626
• Other study ID #: MAF/AGN/OPH/RET/010
• Status: Completed
• Phase: N/A
• First received: September 30, 2011
• Last updated: January 14, 2013
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Macular oedema in the study eye due to BRVO or CRVO

• Received at least 2 OZURDEX® injections in the study eye

Exclusion Criteria:

• Received OZURDEX® injections as part of or during any clinical study

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Macular Edema

Intervention

Drug:
• dexamethasone intravitreal implant 0.7 mg
Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to OZURDEX® Re-injection	Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.	Up to 12 months	No
Secondary	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.	Baseline, 7 to 12 weeks following the last injection	No
Secondary	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.	Baseline, Up to 12 months	No
Secondary	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.	Baseline, Up to 12 months	No
Secondary	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.	Baseline, 7 to 12 weeks following the last injection	No
Secondary	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).	Baseline, Up to 12 months	No
Secondary	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).	Baseline, Up to 12 months	No