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Ranibizumab for Neovascularization in Sickle Cell Retinopathy
This study has been withdrawn prior to recruitment.
( Study did not enroll any study participants. )
First Received: February 7, 2008   Last Updated: August 13, 2009   History of Changes
Sponsors and Collaborators: Truman Medical Center
University of Missouri, Kansas City
Genentech
Information provided by: Truman Medical Center
ClinicalTrials.gov Identifier: NCT00618644
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Truman Medical Center:

Primary Outcome Measures:
  • Ocular safety of a single dose of ranibizumab [ Time Frame: Three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in vision status [ Time Frame: Three months ] [ Designated as safety issue: No ]
  • To evaluate ocular hemorrhage [ Time Frame: Three months. ] [ Designated as safety issue: Yes ]

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
1: Experimental
Ranibizumab injection
Drug: Ranibizumab
Ranibizumab 0.5 mg intravitreal injection

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618644

Sponsors and Collaborators
Truman Medical Center
University of Missouri, Kansas City
Genentech
Investigators
Principal Investigator: Nelson R Sabates, MD Truman Medical Center and UMKC Vision Research Center
  More Information

Publications:
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Anemia, Hemolytic, Congenital
Pathologic Processes
Genetic Diseases, Inborn
Hematologic Diseases
Eye Diseases
Metaplasia
Hemoglobinopathies
Anemia
Anemia, Hemolytic
Neovascularization, Pathologic
Anemia, Sickle Cell
Retinal Diseases

ClinicalTrials.gov processed this record on September 11, 2009