Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
This is a single-masked study to compare intravitreally administered 0.5 mg ranibizumab to 2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than 30 days following treatment with intravitreal anti-VEGF therapy. Patients will be masked to their treatment assignment.
The study duration is anticipated to be 12 months and will enroll 30 subjects . Patients will be randomized 2:1 to either 2.0 mg ranibizumab or 0.5mg ranibizumab.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucentis 2.0 mg | Experimental | Lucentis 2.0 mg |
|
| LUCENTIS 0.5 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | 2.0 mg |
| |
| Ranibizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Visual Acuity (VA) From Baseline at Month 6 | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Visual Acuity (VA) From Baseline at Month 12 |
|
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| K.Bailey Freund, MD | Vitreous -Retina- Macula Consultants of New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitreous Retina Macula Consultants of New York | New York | New York | 10022 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lucentis 2.0 mg | Lucentis (ranibizumab) 2.0 mg |
| FG001 | Lucentis 0.5 mg | Lucentis (ranibizumab) 0.5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
0.5 mg |
|
| one year |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lucentis 2.0 mg | Lucentis (ranibizumab) 2.0 mg |
| BG001 | Lucentis 0.5 mg | Lucentis (ranibizumab) 0.5 mg |
| 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, Customized | 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 | Mean Change in Visual Acuity (VA) From Baseline at Month 6 | Posted | Mean | Standard Deviation | ETDRS Letters | Baseline and 6 months |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change in Visual Acuity (VA) From Baseline at Month 12 |
| Posted | Mean | Standard Deviation | ETDRS Letters | one year |
|
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lucentis 2.0 mg | Lucentis (ranibizumab) 2.0 mg | 0 | 9 | 0 | 9 | ||
| EG001 | Lucentis 0.5 mg | Lucentis (ranibizumab) 0.5 mg | 0 | 9 | 0 | 9 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| K. Bailey Freund, MD (or Galyna Ganieva, Research Manager) | Vitreous Retina Macula Consultants of New York | 212-861-9797 | 6929 | gganieva@vrmny.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Male |
|
|