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This is a study designed to determine if the addition of Ozurdex® to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.
This is a multicenter clinical study designed to determine if the addition of Ozurdex® injection to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Sham Comparator | Active bevacizumab (Avastin®) and Sham Ozurdex® |
|
| Group 2 | Active Comparator | Active bevacizumab (Avastin®) and Active Ozurdex® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active bevacizumab and Sham dexamethasone | Drug | Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24 | The secondary efficacy endpoint is the visual acuity score based on best corrected visual acuity (BCVA) at Week 24 Change in BCVA at Week 24 from baseline | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl Csaky, MD | Texas Retina Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
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A total of 68 participants ≥18 years of age with a diagnosis of central retinal vein occlusion (CRVO) as determined by fundus photography and fluorescein angiography were enrolled in the study at 5 clinical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Active bevacizumab (Avastin®) and Sham Ozurdex® Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe |
| FG001 | Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Active bevacizumab and Active dexamethasone | Drug | Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose |
|
|
Active bevacizumab (Avastin®) and Active Ozurdex® Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Active bevacizumab (Avastin®) and Sham Ozurdex® Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe |
| BG001 | Group 2 | Active bevacizumab (Avastin®) and Active Ozurdex® Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Previous Injections | Count of Participants | Participants |
| ||||||||||||||||
| Study Eye | Count of Participants | Participants |
| ||||||||||||||||
| Baseline best corrected visual acuity (BCVA) in Study Eye | Best corrected visual acuity (BCVA): best possible vision a person can achieve with corrective lenses, measured using the method from the early treatment for diabetic retinopathy study (ETDRS) protocol. BCVA ranges from 0 to 100. | Mean | Standard Deviation | letters |
| ||||||||||||||
| Baselinen best corrected visual acuity (BCVA) in Fellow Eye | Best corrected visual acuity (BCVA): best possible vision a person can achieve with corrective lenses, measured using the method from the early treatment for diabetic retinopathy study (ETDRS) protocol. BCVA ranges from 0 to 100. | Mean | Standard Deviation | letters |
| ||||||||||||||
| Baseline Central Foveal Thickness in Study Eye | Mean | Standard Deviation | microns |
| |||||||||||||||
| Baseline Central Foveal Thickness in Fellow Eye | Mean | Standard Deviation | microns |
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| 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 | The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks | Posted | Count of Participants | Participants | 24 weeks |
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| Secondary | The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24 | The secondary efficacy endpoint is the visual acuity score based on best corrected visual acuity (BCVA) at Week 24 Change in BCVA at Week 24 from baseline | Posted | Mean | Standard Deviation | letters | 24 weeks |
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24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Active bevacizumab (Avastin®) and Sham Ozurdex® Active bevacizumab and Sham dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe | 0 | 35 | 0 | 35 | 0 | 35 |
| EG001 | Group 2 | Active bevacizumab (Avastin®) and Active Ozurdex® Active bevacizumab and Active dexamethasone: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose | 0 | 33 | 0 | 33 | 0 | 33 |
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Limitations of this study included the relatively small size of 68 eyes, however statistical analyses were robust. The sample size was small due to the disease of study being a rare disease of study so the sample size is limited.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Traci Clemons | The Emmes Corporation | 1-301-251-1161 | 10212 | tclemons@emmes.com |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Male |
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| Black |
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| Caucasian |
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| Hispanic |
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| Not Reported |
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| No Injection |
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| Ranibizumab |
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| Bevacizumab and Ranibizumab |
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| Bevacizumab and Aflibercept |
|
| Left Eye |
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| 2 PRN Injections |
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| 3 PRN Injections |
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| 4 PRN Injections |
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