Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OZURDEX® | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone implant | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29642062 | Background | Yoon YH, Kim JW, Lee JY, Kim IT, Kang SW, Yu HG, Koh HJ, Kim SS, Chang DJ, Simonyi S. Dexamethasone Intravitreal Implant for Early Treatment and Retreatment of Macular Edema Related to Branch Retinal Vein Occlusion: The Multicenter COBALT Study. Ophthalmologica. 2018;240(2):81-89. doi: 10.1159/000487547. Epub 2018 Apr 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent-to-treat (ITT) population included all enrolled participants. "n" in the category is the number of participants with data available for analysis. | Posted | Mean | Standard Deviation | letters | Baseline, Month 6 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 18.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| Baseline, Month 12 |
| 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. | Baseline, Month 12 |
| 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. | Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 |
| 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. | Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 |
| 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. | Baseline, Months 6 and 12 |
| Percentage of Participants Receiving a Second Injection | 12 Months |
| Percentage of Participants Receiving a Third Injection | 12 Months |
| Time to Second Injection | Time in weeks from the first injection to the second injection. | 12 Months |
| Time to Third Injection | Time in weeks from the second injection to the third injection. | 12 Months |
| 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. | 12 Months |
| Lost to Follow-up |
|
| Treatment with alternative drug |
|
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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. | ITT population included all enrolled participants. "n" in the category is the number of participants with data available for analysis. | Posted | Mean | Standard Deviation | micrometers (μm) | Baseline, Month 6 |
|
|
|
| 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. | ITT population included all enrolled participants. "n" in the category is the number of participants with data available for analysis. | Posted | Mean | Standard Deviation | letters | Baseline, Month 12 |
|
|
|
| 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. | ITT population included all enrolled participants. "n" in the category is the number of participants with data available for analysis. | Posted | Mean | Standard Deviation | μm | Baseline, Month 12 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | letters | Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | micrometers (μm) | Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 |
|
|
|
| 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. | 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. | Posted | Number | percentage of participants | Baseline, Months 6 and 12 |
|
|
|
| Secondary | Percentage of Participants Receiving a Second Injection | ITT population included all enrolled participants. | Posted | Number | percentage of participants | 12 Months |
|
|
|
| Secondary | Percentage of Participants Receiving a Third Injection | ITT population included all enrolled participants. | Posted | Number | percentage of participants | 12 Months |
|
|
|
| Secondary | Time to Second Injection | Time in weeks from the first injection to the second injection. | ITT population included all enrolled participants. | Posted | Mean | Standard Deviation | weeks | 12 Months |
|
|
|
| Secondary | Time to Third Injection | Time in weeks from the second injection to the third injection. | ITT population included all enrolled participants. | Posted | Mean | Standard Deviation | weeks | 12 Months |
|
|
|
| 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. | ITT population included all enrolled participants. | Posted | Number | percentage of participants | 12 Months |
|
|
|
| 2 |
| 71 |
| 44 |
| 71 |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
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.
| D020246 |
| Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| Title | Measurements |
|---|---|
|
| Change from Baseline at Month 2 (n=62) |
|
| Change from Baseline at Month 3 (n=63) |
|
| Change from Baseline at Month 4 (n=59) |
|
| Change from Baseline at Month 5 (n=63) |
|
| Change from Baseline at Month 6 (n=62) |
|
| Change from Baseline at Month 7 (n=60) |
|
| Change from Baseline at Month 8 (n=61) |
|
| Change from Baseline at Month 9 (n=59) |
|
| Change from Baseline at Month 10 (n=60) |
|
| Change from Baseline at Month 11 (n=59) |
|
| Change from Baseline at Month 12 (n=59) |
|
|
| Change from Baseline at Month 2 (n=62) |
|
| Change from Baseline at Month 3 (n=63) |
|
| Change from Baseline at Month 4 (n=59) |
|
| Change from Baseline at Month 5 (n=63) |
|
| Change from Baseline at Month 6 (n=62) |
|
| Change from Baseline at Month 7 (n=60) |
|
| Change from Baseline at Month 8 (n=60) |
|
| Change from Baseline at Month 9 (n=59) |
|
| Change from Baseline at Month 10 (n=59) |
|
| Change from Baseline at Month 11 (n=59) |
|
| Change from Baseline at Month 12 (n=59) |
|
| Title | Measurements |
|---|---|
|
| Month 12_Decrease (n=59) |
|