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Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema |
|
| Group 2 | Active Comparator | Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avastin | Drug | 1.25mg intravitreally |
| |
| Osurdex |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Visual Acuity at 6 Months | Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Injections Needed | number of Avastin and Ozurdex injections needed | baseline to 6 months |
| Change in Macular Thickness and Macular Volume | OCT central subfield thickness measured in microns |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raj K Maturi, MD | Raj K. Maturi, MD, PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raj K. Maturi, MD | Indianapolis | Indiana | 46290 | United States |
In total there were 10 screen failures; 4 did not meet the visual acuity requirements,3 did not meet the OCT requirements. One subject withdrew consent prior to randomization and one withdrew prior to randomization due to health issues
The study was conducted at a single center. The first subject for this study was screened on 18MAR2010 and enrolled on 26MAR2010. The subjects were existing patients in our medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 micros |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
0.7mg intravitreally |
|
| Avastin | Drug | 1.25mg intravitreally |
|
| 6 months |
| FG001 |
| Group 2 |
Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros |
| BG001 | Group 2 | Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Visual Acuity at 6 Months | Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. | Posted | Mean | Standard Deviation | ETDRS score | 6 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Injections Needed | number of Avastin and Ozurdex injections needed | Posted | Number | injections | baseline to 6 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Change in Macular Thickness and Macular Volume | OCT central subfield thickness measured in microns | Posted | Mean | Standard Deviation | microns | 6 months |
|
|
6 months
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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 | Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros | 4 | 15 | 13 | 15 | ||
| EG001 | Group 2 | Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns. | 3 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| esophageal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| viral influenza | Immune system disorders | Systematic Assessment |
| ||
| osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| organ transplant rejection | Immune system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| worsening of cataract | Eye disorders | Systematic Assessment |
| ||
| worsening of hypertension | Cardiac disorders | Systematic Assessment |
| ||
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Meniere's disease | Ear and labyrinth disorders | Systematic Assessment |
| ||
| osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| generalized weakness | General disorders | Systematic Assessment |
| ||
| increased intraocular pressure | Eye disorders | Systematic Assessment |
| ||
| worsening of epiretinal membrane | Eye disorders | Systematic Assessment |
| ||
| subconjunctival hemorrhage | Eye disorders | Systematic Assessment |
| ||
| urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| contusion left foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| sinusitis | Ear and labyrinth disorders | Systematic Assessment |
| ||
| inner ear infection | Ear and labyrinth disorders | Systematic Assessment |
| ||
| vitreous floaters | Eye disorders | Systematic Assessment |
| ||
| infection left foot | Infections and infestations | Systematic Assessment |
| ||
| auditory disturbance | Ear and labyrinth disorders | Systematic Assessment |
| ||
| puncture wounds to hands | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| blurry vision | Eye disorders | Systematic Assessment |
| ||
| tooth infection | Infections and infestations | Systematic Assessment |
| ||
| discomfort right eye | Eye disorders | Systematic Assessment |
| ||
| nonfunctioning gallbladder | Hepatobiliary disorders | Systematic Assessment |
| ||
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| cholescystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| headache | General disorders | Systematic Assessment |
| ||
| nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raj K. Maturi, MD | Raj K. Maturi, MD, PC | 317-817-1414 | rmaturi@gmail.com |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| 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 |
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| >=65 years |
|
| Male |
|
|
|