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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The primary objective:
*To measure the difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment (PVD) positive and Posterior Vitreous Detachment (PVD) negative group.
Secondary Objective:
This is an open-label study, of intravitreally administered Ranibizumab in eyes with Age-related Macular Degeneration (AMD), specifically looking at the correlation between the presence of Posterior Vitreous Detachment(PVD) and the number of intravitreal injections of Ranibizumab required. 40 subjects from the offices of Vision Research Foundation will be enrolled in this study. Subjects will be assigned to either a Posterior Vitreous Detachment (PVD) positive group or a Posterior Vitreous Detachment (PVD) negative group based on a pre-treatment ultrasound. A maximum of 20 subjects in each group will be enrolled. Subject accrual into the trial is expected to be completed within 6 months.
All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after the first 4 injections, will be on an as needed basis, based on predefined criteria. Eyes will be evaluated with a full ocular examination, visual acuity measurement (ETDRS chart at a distance of 4 meters),OCT,FA,Fundus Photos, B-scan Ultrasound and subject adverse event monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subfoveal CNV, secondary to AMD with PVD | Active Comparator | 20 eyes with Subfoveal Choroidal Neovascularization, secondary to Age Related Macular Degeneration, with Posterior Vitreous Detachment (PVD Positive). All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after. |
|
| Subfoveal CNV, secondary to AMD w/o PVD | Active Comparator | 20 eyes with Subfoveal Choroidal Neovascularization, secondary to Age Related Macular Degeneration, without Posterior Vitreous Detachment (PVD Negative). All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after the first 4 injections, will be on an as needed basis, based on predefined criteria. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | All study eyes will receive 0.5mg, of intravitreous monthly injections of ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment positive and Posterior Vitreous Detachment negative group | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in visual acuity from Baseline to Month 12 | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael T Trese, MD | Vision Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision Research Foundation | Royal Oak | Michigan | 48073 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 28, 2014 | |
| Reset | Mar 14, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 28, 2014 | Mar 14, 2014 |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
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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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| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |