Ranibizumab for Neovascularization in Sickle Cell Retinopathy

This study has been withdrawn prior to enrollment.
(Withdrawn due to lack of eligible participants)
Sponsor:
Collaborators:
Wayne State University
Genentech, Inc.
Information provided by:
Kresge Eye Institute
ClinicalTrials.gov Identifier:
NCT00618644
First received: February 7, 2008
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Sickle Cell Anemia
Retinopathy
Drug: Ranibizumab

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Kresge Eye Institute:

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 ]

Enrollment: 0
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ranibizumab injection
Drug: Ranibizumab
Ranibizumab 0.5 mg intravitreal injection
Other Name: Lucentis (ranibizumab)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Michigan
Kresge Eye Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Kresge Eye Institute
Wayne State University
Genentech, Inc.
Investigators
Principal Investigator: Vinay Shah, MD Kresge Eye Institute
  More Information

Publications:
Responsible Party: Vinay A. Shah, M.D., Kresge Eye Institute
ClinicalTrials.gov Identifier: NCT00618644     History of Changes
Other Study ID Numbers: 08-08, FVF4232s
Study First Received: February 7, 2008
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014