Ranibizumab for Neovascularization in Sickle Cell Retinopathy
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|ClinicalTrials.gov Identifier: NCT00618644|
Recruitment Status : Withdrawn (Withdrawn due to lack of eligible participants)
First Posted : February 20, 2008
Last Update Posted : September 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Anemia Retinopathy||Drug: Ranibizumab||Not Applicable|
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.
- Among patients with SC or SThal, the incidence of proliferation sickle cell retinopathy is 33% and 14% respectively.
- Proliferative sickle cell retinopathy is the major cause of vision loss in sickle cell disease.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase I Study to Evaluate the Ocular and Non Ocular Safety of Ranibizumab in Treating Neovascularization Secondary to Sickle Cell Retinopathy|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Ranibizumab 0.5 mg intravitreal injection
Other Name: Lucentis (ranibizumab)
- Ocular safety of a single dose of ranibizumab [ Time Frame: Three months ]
- Change in vision status [ Time Frame: Three months ]
- To evaluate ocular hemorrhage [ Time Frame: Three months. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618644
|United States, Michigan|
|Kresge Eye Institute|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Vinay Shah, MD||Kresge Eye Institute|