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Per study sponsor decision.
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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To determine if patients treated early after diagnosis of wet age-related macular degeneration can return/maintain to their baseline pre-disease BCVA.
We will conduct an open label, multi-center study of naïve AMD patients that are identified early upon disease progression (had a normal VA, FA or OCT within 4 months prior to entry) to assess if treating with ranibizumab monthly can restore all patients to their baseline vision pre-AMD. Recent randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with ranibizumab in patients with subfoveal CNV from AMD leads to stabilization of vision in over 90% of patients and improvement in vision in at least a third of the patients and has led to the approval of ranibizumab (0.5 mg) for the treatment of neovascular AMD.
Patients will receive monthly intravitreal ranibizumab injections for 12 months (with dose holding for return to baseline/ 20/20 or better and no evidence of fluid on SD-OCT or FA). All patients will have ETDRS vision and SD-OCT, and complete exam at each monthly visit. Patients will each have a blood analysis for genetics (either during the GALLEY study in which they converted to wet AMD and entered COMPASS or during this study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 0.5 mg | Other | Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months | PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here. | Baseline, Month 6 and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months. | Mean change was measured by letters gained or lost. A positive number is letters gained, and a negative number is letters lost. | Baseline, Month 6 and Month 12 |
| Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Ferreyra, MD | University of California, San Diego | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Retina Consultants | Bakersfield | California | 93309 | United States | ||
| Shiley Eye Center, UCSD |
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The Principal Investigator is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from 'UCSD' site. Data from these participants is being reported here.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab 0.5 mg | Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline, Month 6 and Month 12 |
| La Jolla |
| California |
| 92093 |
| United States |
| California Retina Consultants | Santa Barbara | California | 93103 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| COMPLETED |
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| NOT COMPLETED |
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PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab 0.5 mg | Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline. |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here | Number | 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 | Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months | PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here. | PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here. | Posted | Count of Participants | Participants | Baseline, Month 6 and Month 12 |
|
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| ||||||||||||||||||||||||||
| Secondary | Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months. | Mean change was measured by letters gained or lost. A positive number is letters gained, and a negative number is letters lost. | PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here. | Posted | Mean | Standard Deviation | letters | Baseline, Month 6 and Month 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months | PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here.The CFT image for one participant could not be located, so only 5 of the 6 enrolled participants data are being reported. | Posted | Mean | Standard Deviation | microns | Baseline, Month 6 and Month 12 |
|
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PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here
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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 0.5 mg | Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline. | 0 | 12 | 6 | 12 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-ST segment elevation myocardial infarction | Cardiac disorders |
| |||
| Decrease/Blurry Vision | Eye disorders |
| |||
| Eye Pain | Eye disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Henry Ferreyra | Univeristy of California, San Diego | 858-822-7982 | hferreyra@ucsd.edu |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| 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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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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