Trial Outcomes & Findings for Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO) (NCT NCT01568021)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

1 Year

Results posted on

2015-02-10

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	99
Overall Study COMPLETED	83
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OZURDEX® n=99 Participants 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.
Age, Customized < 45 years	1 participants n=99 Participants
Age, Customized 45 to 65 years	24 participants n=99 Participants
Age, Customized > 65 years	74 participants n=99 Participants
Sex: Female, Male Female	41 Participants n=99 Participants
Sex: Female, Male Male	58 Participants n=99 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: All Participants with complete data.

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.

Outcome measures

Outcome measures
Measure	OZURDEX® n=99 Participants 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.
Time to First Re-treatment	157 days Interval 134.0 to 189.0

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24 and 48

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

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.

Outcome measures

Outcome measures
Measure	OZURDEX® n=99 Participants 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.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Baseline	52.8 letters Standard Deviation 15.61
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Change from Baseline at Week 12 (n= 68)	8.5 letters Standard Deviation 13.16
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Change from Baseline at Week 24 (n= 75)	6.9 letters Standard Deviation 13.01
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Change from Baseline at Week 48 (n= 75)	2.5 letters Standard Deviation 18.61

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24 and 48

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

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.

Outcome measures

Outcome measures
Measure	OZURDEX® n=99 Participants 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.
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) Baseline (n- 93)	535.2 microns Standard Deviation 166.75
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) Change from Baseline at Week 12 (n= 63)	-181.3 microns Standard Deviation 198.25
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) Change from Baseline at Week 24 (n= 69)	-160.4 microns Standard Deviation 185.45
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) Change from Baseline at Week 48 (n= 70)	-147.7 microns Standard Deviation 191.63

Adverse Events

OZURDEX®

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OZURDEX® n=99 participants at risk 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.
Eye disorders Endophthalmitis	1.0% 1/99 Only Treatment-Related Adverse Events were collected in this Post Marketing Surveillance Study.

Other adverse events

Other adverse events
Measure	OZURDEX® n=99 participants at risk 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.
Eye disorders Ocular hypertension	26.3% 26/99 Only Treatment-Related Adverse Events were collected in this Post Marketing Surveillance Study.

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER