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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose Ranibizumab | Active Comparator | 6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart. |
|
| Standard Dose Ranibizumab | Active Comparator | 6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab 2 mg | Drug | intravitreal injections of ranibizumab once a month, times 3. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Thickness | baseline and 1 year | |
| Visual Acuity (LogMar) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter E Liggett, MD | New England Retina Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New England Retina Associates | Hamden | Connecticut | 06518 | United States |
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| Label | URL |
|---|---|
| New England Retina Associates website. It contains all the clinical trials that we are running. | View source |
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10 participants were enrolled - 2 participants were eliminated early in the study for non compliance.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose Ranibizumab | patients will receive 3 injections of Ranibizumab (2 mg) a month apart. Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3. |
| FG001 | Standard Dose Ranibizumab | patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months. 0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Ranibizumab | patients will receive 3 injections of Ranibizumab (2 mg) a month apart. Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3. |
| BG001 | Standard Dose Ranibizumab |
| 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 | To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications. | complications were only assessed in the high dose group | Posted | Number | participant | 1 year |
|
|
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Adverse event data are not available to be reported per group or according to severity because the PI left the institution and adverse event data in the required format is not available.
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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 | High Dose Ranibizumab | patients will receive 3 injections of Ranibizumab (2 mg) a month apart. Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Hurst- study coordinator | New England Retina Associates | 203-288-2020 | lhurst@retinamd.com |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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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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| 0.5 mg Ranibizumab | Drug | 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months. |
|
patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Tumor Thickness | Posted | Mean | Full Range | millimeters (mm) | baseline and 1 year |
|
|
|
| Secondary | Visual Acuity (LogMar) | Posted | Number | LogMar | 12 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard Dose Ranibizumab | patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months. 0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months. | 0 | 0 | 0 | 0 |
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| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Patient 03 |
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| Patient 04 |
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| Patient 05 |
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| Patient 06 |
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| Patient 07 |
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| Patient 08 |
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