Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01568021
• Collaborator: (none)
• Enrollment: 100
• Locations: 3
• Duration (Months): 25
• Patients Per Site: 33.3
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in clinical practice, and will assess the time at which patients are considered for retreatment.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vein Occlusion; Macular Edema	Other: No Intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
OZURDEX® Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.	Other: No Intervention; No intervention was administered in this study.

Outcome Measures

Primary Outcome Measures

1. Time to First Re-treatment [1 Year]

   Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye.

Secondary Outcome Measures

1. Change From Baseline in Best Corrected Visual Acuity (BCVA) Score [Baseline, Weeks 12, 24 and 48]

   BCVA was measured in the study eye using an eye chart and was 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 improved.

2. Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) [Baseline, Weeks 12, 24 and 48]

   Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Macular Edema

• Prescribed OZURDEX®

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Glostrup		Denmark
2		Oslo		Norway
3		Uppsala		Sweden

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01568021
• Other Study ID Numbers: MAF/AGN/OPH/RET/007
• First Posted: Apr 2, 2012
• Last Update Posted: Feb 10, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Macular Edema; Retinal Vein Occlusion

Study Results

Participant Flow

Pre-assignment Detail	This was a Post-Marketing Surveillance Study of OZURDEX®. 100 participants who received OZURDEX® as standard of care in clinical practice were enrolled in the study. Only 99 participants who had data recorded at Baseline and Follow-up were included in the analyses.

Arm/Group Title	OZURDEX®
Arm/Group Description	Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
Period Title: Overall Study
STARTED	99
COMPLETED	83
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	OZURDEX®
Arm/Group Description	Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
Overall Participants	99
Age, Customized (participants) [Number]
< 45 years	1 1%
45 to 65 years	24 24.2%
> 65 years	74 74.7%
Sex: Female, Male (Count of Participants)
Female	41 41.4%
Male	58 58.6%

Outcome Measures

1. Primary Outcome

Title	Time to First Re-treatment
Description	Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

All Participants with complete data.

Arm/Group Title	OZURDEX®
Arm/Group Description	Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
Measure Participants	99
Median (95% Confidence Interval) [days]	157

2. Secondary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity (BCVA) Score
Description	BCVA was measured in the study eye using an eye chart and was 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 improved.
Time Frame	Baseline, Weeks 12, 24 and 48

Outcome Measure Data

Analysis Population Description

All participants with complete data at the given time-point.

Arm/Group Title	OZURDEX®
Arm/Group Description	Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
Measure Participants	99
Baseline	52.8 (15.61)
Change from Baseline at Week 12 (n= 68)	8.5 (13.16)
Change from Baseline at Week 24 (n= 75)	6.9 (13.01)
Change from Baseline at Week 48 (n= 75)	2.5 (18.61)

3. Secondary Outcome

Title	Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Description	Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement.
Time Frame	Baseline, Weeks 12, 24 and 48

Outcome Measure Data

Analysis Population Description

All participants with complete data at the given time-point.

Arm/Group Title	OZURDEX®
Arm/Group Description	Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
Measure Participants	99
Baseline (n- 93)	535.2 (166.75)
Change from Baseline at Week 12 (n= 63)	-181.3 (198.25)
Change from Baseline at Week 24 (n= 69)	-160.4 (185.45)
Change from Baseline at Week 48 (n= 70)	-147.7 (191.63)

Adverse Events

Adverse Event Reporting Description	Only Treatment-Related Adverse Events were collected in this Post Marketing Surveillance Study.
Arm/Group Title	OZURDEX®
Arm/Group Description	Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
All Cause Mortality
	OZURDEX®
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	OZURDEX®
	Affected / at Risk (%)	# Events
Total	1/99 (1%)
Eye disorders
Endophthalmitis	1/99 (1%)
Other (Not Including Serious) Adverse Events
	OZURDEX®
	Affected / at Risk (%)	# Events
Total	26/99 (26.3%)
Eye disorders
Ocular hypertension	26/99 (26.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.