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Sponsors and Collaborators: |
Truman Medical Center University of Missouri, Kansas City Genentech |
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Information provided by: | Truman Medical Center |
ClinicalTrials.gov Identifier: | NCT00618644 |
The purpose of this study is to determine the color and non-ocular safety of a single dose of ranibizumab in treating neovascularization secondary to sickle cell retinopathy.
Condition | Intervention |
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Sickle Cell Anemia Retinopathy |
Drug: Ranibizumab |
Study Type: | Interventional |
Study Design: | Treatment, Double Blind (Subject, Investigator), Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study to Evaluate the Ocular and Non Ocular Safety of Ranibizumab in Treating Neovascularization Secondary to Sickle Cell Retinopathy |
Estimated Enrollment: | 3 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Ranibizumab injection
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Drug: Ranibizumab
Ranibizumab 0.5 mg intravitreal injection
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In the U.S., about 10% of African Americans have an abnormal hemoglobin gene. About 8% of African Americans are heterozygous for Hemoglobin S. In the United States, sickle cell anemia primarily occurs in the black population, with approximately 0.2% of African American children afflicted by this disease. It may be associated with other hemoglobinopathies as well. The prevalence in adults is lower because of the decrease in life expectancy.
Systemically, the sickle cell anemia variation (SS) produces the most symptoms. With respect to the eye, the sickle cell disease mutation (SC) produces the most effects. Overall, the sickle cell trait expression (AS) produces the fewest complications.
For sickle cell retinopathy, the commonly used therapeutic modalities include laser retinal photocoagulation, retinal cryotherapy, and vitrectomy/membranectomy depending on the severity of the disease. The most effective therapeutic modality with minimal postoperative complications appears to be scatter laser retinal photocoagulation.
A single case study of bevacizumab was found to effective in short term regression of neovascularization and improving vision after a single injection. Further study with ranibizumab is warranted.
Recent clinical trials (Marina and Anchor) have demonstrated that ranibizumab is effective in treating patients with CNV with age-related macular degeneration. Retinopathy in sickle cell disease has also been linked to VEGF.
Therefore, patients with sickle cell retinopathy should respond to ranibizumab therapy.
This is an open-label single dose, phase I study of intravitreally administered ranibizumab in patients with sickle cell retinopathy.
Consented, enrolled subjects will receive a single open-label intravitreal injection of 0.5 mg ranibizumab.
Three subjects from one site in the United States will be enrolled.
Patients will receive one dose of 0.5 mg ranibizumab administered intravitreally.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Truman Medical Center ( Vinay A. Shah, M.D. ) |
Study ID Numbers: | 08-08, FVF4232s |
Study First Received: | February 7, 2008 |
Last Updated: | August 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00618644 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hematologic Diseases Eye Diseases Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hemoglobinopathies |
Metaplasia Neoplasm Metastasis Sickle Cell Anemia Neovascularization, Pathologic Hemoglobinopathy Anemia, Sickle Cell Retinal Diseases |
Anemia, Hemolytic, Congenital Pathologic Processes Genetic Diseases, Inborn Hematologic Diseases Eye Diseases Metaplasia |
Hemoglobinopathies Anemia Anemia, Hemolytic Neovascularization, Pathologic Anemia, Sickle Cell Retinal Diseases |