Ranibizumab for Neovascularization in Sickle Cell Retinopathy

Brief Summary

Official Title: “A Phase I Study to Evaluate the Ocular and Non Ocular Safety of Ranibizumab in Treating Neovascularization Secondary to Sickle Cell Retinopathy”

The purpose of this study is to determine the ocular and non-ocular safety of a single dose of ranibizumab in treating neovascularization secondary to sickle cell retinopathy.

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: June 2011

Detailed Clinical Trial Description

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.

Interventions Used in this Clinical Trial

  • Drug: Ranibizumab
    • Ranibizumab 0.5 mg intravitreal injection

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Ranibizumab injection

Outcome Measures for this Clinical Trial

Primary Measures

  • Ocular safety of a single dose of ranibizumab
    • Time Frame: Three months
      Safety Issue?: Yes

Secondary Measures

  • Change in vision status
    • Time Frame: Three months
      Safety Issue?: No
  • To evaluate ocular hemorrhage
    • Time Frame: Three months.
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Patients with sickle cell anemia and retinopathy
  • Over age 18 years
  • Non-pregnant

Exclusion Criteria

  • Pregnant
  • Glaucoma
  • Patients using anticoagulants (e.g., warfarin)
  • Retinal detachment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Kresge Eye Institute
  • Collaborator
    • Wayne State University
  • Provider of Information About this Clinical Study
    • Vinay A. Shah, M.D., Kresge Eye Institute
  • Overall Official(s)
    • Vinay Shah, MD, Principal Investigator, Kresge Eye Institute

References

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.

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.

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. No abstract available.

Chalam KV, Shah VA. Macular infarction a presentation of sickle cell crisis. Eye. 2004 Dec;18(12):1277-8. No abstract available.

Avery RL. Regression of retinal and iris neovascularization after intravitreal bevacizumab (Avastin) treatment. Retina. 2006 Mar;26(3):352-4. 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.

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. No abstract available.

Source

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00618644