Trial Outcomes & Findings for A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion (NCT NCT01903720)

Results Overview

BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

71 participants

Primary outcome timeframe

Baseline, Month 6

Results posted on

2019-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	OZURDEX® OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Overall Study STARTED	71
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	OZURDEX® OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Overall Study Inclusion / exclusion criteria not met	6
Overall Study Adverse Event	1
Overall Study Rescinding of informed consent	2
Overall Study Lost to Follow-up	2
Overall Study Treatment with alternative drug	1

Baseline Characteristics

A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OZURDEX® n=71 Participants OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Age, Continuous	57.46 years STANDARD_DEVIATION 9.19 • n=5 Participants
Age, Customized 30 to 39 years	1 participants n=5 Participants
Age, Customized 40 to 49 years	12 participants n=5 Participants
Age, Customized 50 to 59 years	29 participants n=5 Participants
Age, Customized 60 to 69 years	22 participants n=5 Participants
Age, Customized 70 years and over	7 participants n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: Intent-to-treat (ITT) population included all enrolled participants. "n" in the category is the number of participants with data available for analysis.

BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.

Outcome measures

Outcome measures
Measure	OZURDEX® n=71 Participants OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6 Baseline	51.90 letters Standard Deviation 13.55
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6 Change from Baseline at Month 6 (n=62)	18.60 letters Standard Deviation 12.90

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: ITT population included all enrolled participants. "n" in the category is the number of participants with data available for analysis.

CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	OZURDEX® n=71 Participants OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Change From Baseline in Central Retinal Thickness (CRT) at Month 6 Baseline	505.13 micrometers (μm) Standard Deviation 129.91
Change From Baseline in Central Retinal Thickness (CRT) at Month 6 Change from Baseline at Month 6 (n=62)	-246.82 micrometers (μm) Standard Deviation 150.74

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: ITT population included all enrolled participants. "n" in the category is the number of participants with data available for analysis.

BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.

Outcome measures

Outcome measures
Measure	OZURDEX® n=71 Participants OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Change From Baseline in BCVA at Month 12 Baseline	51.90 letters Standard Deviation 13.55
Change From Baseline in BCVA at Month 12 Change from Baseline at Month 12 (n=59)	15.27 letters Standard Deviation 14.99

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: ITT population included all enrolled participants. "n" in the category is the number of participants with data available for analysis.

CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	OZURDEX® n=71 Participants OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Change From Baseline in CRT at Month 12 Baseline	505.13 μm Standard Deviation 129.91
Change From Baseline in CRT at Month 12 Change from Baseline at Month 12 (n=59)	-196.90 μm Standard Deviation 164.07

SECONDARY outcome

Timeframe: Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Population: ITT population included all enrolled participants. "n" in the category is the number of participants with data available at the given time-point for analysis.

BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.

Outcome measures

Outcome measures
Measure	OZURDEX® n=71 Participants OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Change From Baseline in BCVA at Each Visit Baseline	51.90 letters Standard Deviation 13.55
Change From Baseline in BCVA at Each Visit Change from Baseline at Week 1 (n=70)	12.80 letters Standard Deviation 10.69
Change From Baseline in BCVA at Each Visit Change from Baseline at Month 1 (n=66)	16.08 letters Standard Deviation 10.75
Change From Baseline in BCVA at Each Visit Change from Baseline at Month 2 (n=62)	18.84 letters Standard Deviation 12.16
Change From Baseline in BCVA at Each Visit Change from Baseline at Month 3 (n=63)	17.59 letters Standard Deviation 12.90
Change From Baseline in BCVA at Each Visit Change from Baseline at Month 4 (n=59)	14.37 letters Standard Deviation 13.47
Change From Baseline in BCVA at Each Visit Change from Baseline at Month 5 (n=63)	18.10 letters Standard Deviation 13.44
Change From Baseline in BCVA at Each Visit Change from Baseline at Month 6 (n=62)	18.60 letters Standard Deviation 12.90
Change From Baseline in BCVA at Each Visit Change from Baseline at Month 7 (n=60)	18.02 letters Standard Deviation 12.64
Change From Baseline in BCVA at Each Visit Change from Baseline at Month 8 (n=61)	16.02 letters Standard Deviation 13.39
Change From Baseline in BCVA at Each Visit Change from Baseline at Month 9 (n=59)	15.88 letters Standard Deviation 13.35
Change From Baseline in BCVA at Each Visit Change from Baseline at Month 10 (n=60)	17.68 letters Standard Deviation 13.17
Change From Baseline in BCVA at Each Visit Change from Baseline at Month 11 (n=59)	15.54 letters Standard Deviation 14.04
Change From Baseline in BCVA at Each Visit Change from Baseline at Month 12 (n=59)	15.27 letters Standard Deviation 14.99

SECONDARY outcome

Timeframe: Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Population: ITT population included all enrolled participants. "n" in the category is the number of participants with data available at the given time-point for analysis.

CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	OZURDEX® n=71 Participants OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Change From Baseline in CRT at Each Visit Change from Baseline at Month 6 (n=62)	-246.82 micrometers (μm) Standard Deviation 150.74
Change From Baseline in CRT at Each Visit Baseline	505.13 micrometers (μm) Standard Deviation 129.91
Change From Baseline in CRT at Each Visit Change from Baseline at Week 1 (n=70)	-173.67 micrometers (μm) Standard Deviation 140.57
Change From Baseline in CRT at Each Visit Change from Baseline at Month 1 (n=66)	-229.48 micrometers (μm) Standard Deviation 142.45
Change From Baseline in CRT at Each Visit Change from Baseline at Month 2 (n=62)	-255.55 micrometers (μm) Standard Deviation 139.01
Change From Baseline in CRT at Each Visit Change from Baseline at Month 3 (n=63)	-188.17 micrometers (μm) Standard Deviation 179.84
Change From Baseline in CRT at Each Visit Change from Baseline at Month 4 (n=59)	-100.76 micrometers (μm) Standard Deviation 150.97
Change From Baseline in CRT at Each Visit Change from Baseline at Month 5 (n=63)	-202.41 micrometers (μm) Standard Deviation 157.66
Change From Baseline in CRT at Each Visit Change from Baseline at Month 7 (n=60)	-220.13 micrometers (μm) Standard Deviation 143.07
Change From Baseline in CRT at Each Visit Change from Baseline at Month 8 (n=60)	-175.83 micrometers (μm) Standard Deviation 133.93
Change From Baseline in CRT at Each Visit Change from Baseline at Month 9 (n=59)	-211.46 micrometers (μm) Standard Deviation 158.10
Change From Baseline in CRT at Each Visit Change from Baseline at Month 10 (n=59)	-250.97 micrometers (μm) Standard Deviation 133.24
Change From Baseline in CRT at Each Visit Change from Baseline at Month 11 (n=59)	-219.14 micrometers (μm) Standard Deviation 144.47
Change From Baseline in CRT at Each Visit Change from Baseline at Month 12 (n=59)	-196.90 micrometers (μm) Standard Deviation 164.07

SECONDARY outcome

Timeframe: Baseline, Months 6 and 12

Population: ITT population included all enrolled participants. "n" in the category is the number of participants with data available at the given time-point for analysis.

BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). An increase in the number of letters read correctly means that the vision improved and a decrease in the number of letters read correctly means that the vision has worsened.