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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| California Pacific Medical Center | OTHER |
| Pacific Eye Associates | OTHER |
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Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in improved visual function in such patients.Since ranibizumab has been shown to be the most effective therapy for exudative macular degeneration we propose to treat all patients in this study with monthly ranibizumab intravitreal injections.
Patients will be assigned to one of two groups by the flip of a coin. Group #1 for "heads" and Group #2 for "tails".
Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.
Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.
The duration of the study is up to 13 months. This includes up to 30 days during which tests will be performed before treatment. Only one eye will be chosen for the study. Patients can receive up to 12 injections of ranibizumab during this study (the first dose[s], plus additional doses [re treatment as often as every 22 days] if the doctor determines that additional doses are required).
In addition to study drug injections. Several eye examinations and procedures will be performed to evaluate response to treatment. These include: visual acuity testing (eye chart), contrast sensitivity testing, reading speed testing, measurement of time to complete typical daily activities, measurement of the thickness of the central retina, measurement of your central visual field.
On the screening visit and two more times during the study fluorescein angiography will be performed.
The screening tests included the following:
Upon completion of the study at Month 12 and if it were to occur; early termination visit, the following procedures will be performed: vision exam,OCT,microperimetry,FA/Photos,VFQ,reading performance, contrast sensitivity and TIADL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ranibizumab Group 1 | Other | Group 1: 3 monthly injections of 0.5mg then prn |
|
| ranibizumab Group 2 | Other | Group 2: 6 monthly injections of 0.5 mg then prn |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Visual Acuity | Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m ^2 at 8 feet. Number of correctly read letters were reported. | 12 months |
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Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Steven R. Sanislo | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pacific Medical Center | San Francisco | California | 94107 | United States | ||
| Stanford University School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab Group 1 | Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months |
| FG001 | Ranibizumab Group 2 | Group 1: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab Group 1 | Group 1: 3 monthly injections of 0.5mg then prn |
| BG001 | Ranibizumab Group 2 | Group 2: 6 monthly injecions of 0.5mg then prn |
| 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 |
| 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 | Mean Change in Visual Acuity | Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m ^2 at 8 feet. Number of correctly read letters were reported. | Posted | Mean | Standard Deviation | letters | 12 months |
|
12 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 | Ranibizumab Group 1 | Group 1: 3 monthly injections of 0.5mg then prn |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| laceration right leg | Skin and subcutaneous tissue disorders |
Limitations include small number of subjects analyzed and no control group that were untreated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Sanislo, MD | Stanford University | 650-723-6995 | ssanislo@stanford.edu |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Stanford |
| California |
| 94305 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | Ranibizumab Group 2 | Group 2: 6 monthly injections of 0.5 mg then prn | 0 | 12 | 4 | 12 |
| laceration left leg | Skin and subcutaneous tissue disorders |
|
| Mild pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Seasonal allergies | Immune system disorders |
|
| Worsening glaucoma - which eye was not specified | Eye disorders |
|
| visual disturbance - fellow eye | Eye disorders |
|
| development of choroidal neovascularization - fellow eye | Eye disorders |
|
| bruised sturnum | Musculoskeletal and connective tissue disorders | Due to auto accident |
|
| subconjuctival hemorrhage - treatment eye | Eye disorders |
|
| intraretinal hemorrhage - treatment eye | Eye disorders |
|
| vitamin D deficiency | Metabolism and nutrition disorders |
|
| intestinal flu | Gastrointestinal disorders |
|
| rash | Skin and subcutaneous tissue disorders |
|
| pinched nerve | Nervous system disorders |
|
| stroke | Nervous system disorders |
|
| endophthalmitis - fellow eye | Eye disorders |
|
| cold | Immune system disorders |
|
| ache left eye - treatment eye | Eye disorders | after injection procedure |
|
| corneal abrasion - both eyes | Eye disorders |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |