NCT00618644

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

1.4 years

First QC Date

February 7, 2008

Last Update Submit

September 25, 2012

Conditions

Sickle Cell AnemiaRetinopathy

Outcome Measures

Primary Outcomes (1)

  • Ocular safety of a single dose of ranibizumab

    Three months

Secondary Outcomes (2)

  • Change in vision status

    Three months

  • To evaluate ocular hemorrhage

    Three months.

Study Arms (1)

1

EXPERIMENTAL

Ranibizumab injection

Drug: Ranibizumab

Interventions

RanibizumabDRUG

Ranibizumab 0.5 mg intravitreal injection

Also known as: Lucentis (ranibizumab)
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kresge Eye Institute

Detroit, Michigan, 48201, United States

Location

Related Publications (7)

  • 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.

    PMID: 11228315BACKGROUND

  • 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.

    PMID: 9323937BACKGROUND

  • 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.

    PMID: 16682603BACKGROUND

  • 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.

    PMID: 15105819BACKGROUND

  • 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.

    PMID: 16508438BACKGROUND

  • 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.

    PMID: 17021318BACKGROUND

  • 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.

    PMID: 17083555BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle CellRetinal Diseases

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Vinay Shah, MD

    Kresge Eye Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2008

First Posted

February 20, 2008

Study Start

January 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

US(1)