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| Sponsors and Collaborators: |
Retina Vitreous Associates, P.C. Genentech |
|---|---|
| Information provided by: | Retina Vitreous Associates, P.C. |
| ClinicalTrials.gov Identifier: | NCT00533520 |
Purpose
The purpose of this study is to test the safety, tolerability and effectiveness of a higher dose (1.0 mg) of ranibizumab versus the standard dose (0.5 mg), in adults with age related macular degeneration who have never been treated with ranibizumab. An additional purpose is to determine if the higher dose (1.0 mg) of ranibizumab can increase the time between doses beyond that currently needed with the 0.5 mg dose.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Degeneration Choroidal Neovascularization |
Drug: ranibizumab |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
| Official Title: | Evaluation of Dosing Interval of Higher Doses of Ranibizumab |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2007 |
| Arms | Assigned Interventions |
|---|---|
|
A, B: Active Comparator
A subjects will be placed in the 0.5 mg ranibizumab group B subjects will be placed in the 1.0 mg ranibizumab group
|
Drug: ranibizumab
Arm A: 0.5 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner that every 28 days Arm B: 1.0 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner that every 28 days
|
Eligibility| Ages Eligible for Study: | 50 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Brandon G Busbee, MD | 615-320-7911 | bgbusbee@yahool.com |
| Contact: Carl C. Awh, MD | 615-320-7911 | cawh@aol.com |
| United States, Tennessee | |
| Retina Vitreous Associates, P.C. | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Mary A McCain, RN 615-983-6000 maryann@tnretina.com | |
| Contact: Kelly J Winters 615-983-6000 kwinters@tnretina.com | |
| Principal Investigator: | Brandon G Busbee, MD | Retina Vitreous Associates, P.C. |
More Information
| Responsible Party: | Retina Vitreous Associates, P.C. ( Brandon G. Busbee, MD ) |
| Study ID Numbers: | FVF4155s |
| Study First Received: | September 19, 2007 |
| Last Updated: | June 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00533520 |
| Health Authority: | United States: Food and Drug Administration |
|
Metaplasia Eye Diseases Choroid Diseases Retinal Degeneration Macular Degeneration |
Neovascularization, Pathologic Retinal Diseases Retinal degeneration Choroidal Neovascularization |
|
Uveal Diseases Pathologic Processes |
