Ranibizumab for Neovascularization in Sickle Cell Retinopathy

September 25, 2012 updated by: Kresge Eye Institute

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Kresge Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Ranibizumab injection
Drug: Ranibizumab
Ranibizumab 0.5 mg intravitreal injection
Other Names:
  • Lucentis (ranibizumab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ocular safety of a single dose of ranibizumab
Time Frame: Three months
Three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in vision status
Time Frame: Three months
Three months
To evaluate ocular hemorrhage
Time Frame: Three months.
Three months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kresge Eye Institute

Collaborators

Wayne State University
Genentech, Inc.

Investigators

  • Principal Investigator: Vinay Shah, MD, Kresge Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 7, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

September 27, 2012

Last Update Submitted That Met QC Criteria

September 25, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-08
  • FVF4232s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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