Ranibizumab for Neovascularization in Sickle Cell Retinopathy
NCT ID: NCT00618644
Last Updated: 2012-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2010-01-31
2011-06-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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1
Ranibizumab injection
Ranibizumab
Ranibizumab 0.5 mg intravitreal injection
Interventions
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Ranibizumab
Ranibizumab 0.5 mg intravitreal injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Over age 18 years
* Non-pregnant
Exclusion Criteria
* Glaucoma
* Patients using anticoagulants (e.g., warfarin)
* Retinal detachment
18 Years
ALL
No
Sponsors
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Wayne State University
OTHER
Genentech, Inc.
INDUSTRY
Kresge Eye Institute
OTHER
Responsible Party
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Kresge Eye Institute
Principal Investigators
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Vinay Shah, MD
Role: PRINCIPAL_INVESTIGATOR
Kresge Eye Institute
Locations
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Kresge Eye Institute
Detroit, Michigan, United States
Countries
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References
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Al-Abdulla NA, Haddock TA, Kerrison JB, Goldberg MF. Sickle cell disease presenting with extensive peri-macular arteriolar occlusions in a nine-year-old boy. Am J Ophthalmol. 2001 Feb;131(2):275-6. doi: 10.1016/s0002-9394(00)00778-9.
McLeod DS, Merges C, Fukushima A, Goldberg MF, Lutty GA. Histopathologic features of neovascularization in sickle cell retinopathy. Am J Ophthalmol. 1997 Oct;124(4):455-72. doi: 10.1016/s0002-9394(14)70862-1.
Witkin AJ, Rogers AH, Ko TH, Fujimoto JG, Schuman JS, Duker JS. Optical coherence tomography demonstration of macular infarction in sickle cell retinopathy. Arch Ophthalmol. 2006 May;124(5):746-7. doi: 10.1001/archopht.124.5.746. No abstract available.
Chalam KV, Shah VA. Macular infarction a presentation of sickle cell crisis. Eye (Lond). 2004 Dec;18(12):1277-8. doi: 10.1038/sj.eye.6701409. No abstract available.
Avery RL. Regression of retinal and iris neovascularization after intravitreal bevacizumab (Avastin) treatment. Retina. 2006 Mar;26(3):352-4. doi: 10.1097/00006982-200603000-00016. No abstract available.
Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.
Siqueira RC, Costa RA, Scott IU, Cintra LP, Jorge R. Intravitreal bevacizumab (Avastin) injection associated with regression of retinal neovascularization caused by sickle cell retinopathy. Acta Ophthalmol Scand. 2006 Dec;84(6):834-5. doi: 10.1111/j.1600-0420.2006.00779.x. No abstract available.
Other Identifiers
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FVF4232s
Identifier Type: -
Identifier Source: secondary_id
08-08
Identifier Type: -
Identifier Source: org_study_id