Macular Edema, Retinal Vein Occlusion
Conditions
Brief summary
This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.
Interventions
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.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of macular edema * Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye
Exclusion criteria
* Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month * Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months * Any active ocular infection in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6 | Baseline, Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BCVA at Month 12 | Baseline, Month 12 | 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. |
| Change From Baseline in CRT at Month 12 | Baseline, Month 12 | 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. |
| Change From Baseline in BCVA at Each Visit | Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | 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. |
| Change From Baseline in CRT at Each Visit | Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | 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. |
| Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA | Baseline, Months 6 and 12 | 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. |
| Change From Baseline in Central Retinal Thickness (CRT) at Month 6 | Baseline, Month 6 | 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. |
| Percentage of Participants Receiving a Third Injection | 12 Months | — |
| Time to Second Injection | 12 Months | Time in weeks from the first injection to the second injection. |
| Time to Third Injection | 12 Months | Time in weeks from the second injection to the third injection. |
| Percentage of Participants Who Received Laser Treatments | 12 Months | Participants underwent laser photocoagulation therapy for all areas of foveal leakage and non-perfusion, as well as areas of extensive retinal hyperplasia if applicable for rescue therapy. |
| Percentage of Participants Receiving a Second Injection | 12 Months | — |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Inclusion / exclusion criteria not met | 6 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Rescinding of informed consent | 2 |
| Overall Study | Treatment with alternative drug | 1 |
Baseline characteristics
| Characteristic | OZURDEX® |
|---|---|
| Age, Continuous | 57.46 years STANDARD_DEVIATION 9.19 |
| Age, Customized 30 to 39 years | 1 participants |
| Age, Customized 40 to 49 years | 12 participants |
| Age, Customized 50 to 59 years | 29 participants |
| Age, Customized 60 to 69 years | 22 participants |
| Age, Customized 70 years and over | 7 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 71 |
| serious Total, serious adverse events | 2 / 71 |
Outcome results
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6 | Baseline | 51.90 letters | Standard Deviation 13.55 |
| OZURDEX® | 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 12.9 |
Secondary
Change From Baseline in BCVA at Each Visit
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Baseline | 51.90 letters | Standard Deviation 13.55 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Week 1 (n=70) | 12.80 letters | Standard Deviation 10.69 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Month 1 (n=66) | 16.08 letters | Standard Deviation 10.75 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Month 2 (n=62) | 18.84 letters | Standard Deviation 12.16 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Month 3 (n=63) | 17.59 letters | Standard Deviation 12.9 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Month 4 (n=59) | 14.37 letters | Standard Deviation 13.47 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Month 5 (n=63) | 18.10 letters | Standard Deviation 13.44 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Month 6 (n=62) | 18.60 letters | Standard Deviation 12.9 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Month 7 (n=60) | 18.02 letters | Standard Deviation 12.64 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Month 8 (n=61) | 16.02 letters | Standard Deviation 13.39 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Month 9 (n=59) | 15.88 letters | Standard Deviation 13.35 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Month 10 (n=60) | 17.68 letters | Standard Deviation 13.17 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Month 11 (n=59) | 15.54 letters | Standard Deviation 14.04 |
| OZURDEX® | Change From Baseline in BCVA at Each Visit | Change from Baseline at Month 12 (n=59) | 15.27 letters | Standard Deviation 14.99 |
Secondary
Change From Baseline in BCVA at Month 12
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.
Time frame: Baseline, Month 12
Population: ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in BCVA at Month 12 | Baseline | 51.90 letters | Standard Deviation 13.55 |
| OZURDEX® | Change From Baseline in BCVA at Month 12 | Change from Baseline at Month 12 (n=59) | 15.27 letters | Standard Deviation 14.99 |
Secondary
Change From Baseline in Central Retinal Thickness (CRT) at Month 6
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.
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in Central Retinal Thickness (CRT) at Month 6 | Baseline | 505.13 micrometers (μm) | Standard Deviation 129.91 |
| OZURDEX® | 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
Change From Baseline in CRT at Each Visit
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in CRT at Each Visit | Change from Baseline at Month 9 (n=59) | -211.46 micrometers (μm) | Standard Deviation 158.1 |
| OZURDEX® | Change From Baseline in CRT at Each Visit | Baseline | 505.13 micrometers (μm) | Standard Deviation 129.91 |
| OZURDEX® | Change From Baseline in CRT at Each Visit | Change from Baseline at Week 1 (n=70) | -173.67 micrometers (μm) | Standard Deviation 140.57 |
| OZURDEX® | Change From Baseline in CRT at Each Visit | Change from Baseline at Month 1 (n=66) | -229.48 micrometers (μm) | Standard Deviation 142.45 |
| OZURDEX® | Change From Baseline in CRT at Each Visit | Change from Baseline at Month 2 (n=62) | -255.55 micrometers (μm) | Standard Deviation 139.01 |
| OZURDEX® | Change From Baseline in CRT at Each Visit | Change from Baseline at Month 3 (n=63) | -188.17 micrometers (μm) | Standard Deviation 179.84 |
| OZURDEX® | Change From Baseline in CRT at Each Visit | Change from Baseline at Month 4 (n=59) | -100.76 micrometers (μm) | Standard Deviation 150.97 |
| OZURDEX® | Change From Baseline in CRT at Each Visit | Change from Baseline at Month 5 (n=63) | -202.41 micrometers (μm) | Standard Deviation 157.66 |
| OZURDEX® | Change From Baseline in CRT at Each Visit | Change from Baseline at Month 6 (n=62) | -246.82 micrometers (μm) | Standard Deviation 150.74 |
| OZURDEX® | Change From Baseline in CRT at Each Visit | Change from Baseline at Month 7 (n=60) | -220.13 micrometers (μm) | Standard Deviation 143.07 |
| OZURDEX® | Change From Baseline in CRT at Each Visit | Change from Baseline at Month 8 (n=60) | -175.83 micrometers (μm) | Standard Deviation 133.93 |
| OZURDEX® | Change From Baseline in CRT at Each Visit | Change from Baseline at Month 10 (n=59) | -250.97 micrometers (μm) | Standard Deviation 133.24 |
| OZURDEX® | Change From Baseline in CRT at Each Visit | Change from Baseline at Month 11 (n=59) | -219.14 micrometers (μm) | Standard Deviation 144.47 |
| OZURDEX® | 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
Change From Baseline in CRT at Month 12
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.
Time frame: Baseline, Month 12
Population: ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in CRT at Month 12 | Baseline | 505.13 μm | Standard Deviation 129.91 |
| OZURDEX® | Change From Baseline in CRT at Month 12 | Change from Baseline at Month 12 (n=59) | -196.90 μm | Standard Deviation 164.07 |
Secondary
Percentage of Participants Receiving a Second Injection
Time frame: 12 Months
Population: ITT population included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OZURDEX® | Percentage of Participants Receiving a Second Injection | 18.31 percentage of participants |
Secondary
Percentage of Participants Receiving a Third Injection
Time frame: 12 Months
Population: ITT population included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OZURDEX® | Percentage of Participants Receiving a Third Injection | 49.30 percentage of participants |
Secondary
Percentage of Participants Who Received Laser Treatments
Participants underwent laser photocoagulation therapy for all areas of foveal leakage and non-perfusion, as well as areas of extensive retinal hyperplasia if applicable for rescue therapy.
Time frame: 12 Months
Population: ITT population included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OZURDEX® | Percentage of Participants Who Received Laser Treatments | 0.0 percentage of participants |
Secondary
Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OZURDEX® | Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA | Month 6_Increase | 64.52 percentage of participants |
| OZURDEX® | Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA | Month 6_Decrease | 1.61 percentage of participants |
| OZURDEX® | Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA | Month 12_Increase (n=59) | 55.93 percentage of participants |
| OZURDEX® | Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA | Month 12_Decrease (n=59) | 5.08 percentage of participants |
Secondary
Time to Second Injection
Time in weeks from the first injection to the second injection.
Time frame: 12 Months
Population: ITT population included all enrolled participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OZURDEX® | Time to Second Injection | 20.78 weeks | Standard Deviation 6.02 |
Secondary
Time to Third Injection
Time in weeks from the second injection to the third injection.
Time frame: 12 Months
Population: ITT population included all enrolled participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OZURDEX® | Time to Third Injection | 19.20 weeks | Standard Deviation 3.09 |