Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Shields, Shields and Associates.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shields, Shields and Associates
ClinicalTrials.gov Identifier:
NCT00540930
First received: October 5, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

Uveal Melanoma is the most common primary intraocular malignancy in adulthood. Eye preserving treatments can deliver equivalent life prognosis in the management of small and medium sized uveal melanomas, as compared to enucleation. Plaque radiotherapy has emerged as the most common eye-preserving treatment in the current management of uveal melanoma, but is complicated by visual loss in approximately 70% of patients at 10 years follow-up. Strategies for the prevention and early treatment of radiation retinopathy/maculopathy need to be developed to improve visual outcomes following plaque treatment. Ranibizumab (Lucentis) is the antigen binding fragment of a recombinant, humanized monoclonal antibody, which inhibits the activity of vascular endothelial growth factor A, a mediator in the development of choroidal neovascularization. Lucentis is commonly used in the eye for eye conditions such as age related macular degeneration. This study will investigate the possible benefit of Anti-VEGF therapy (Lucentis) in reducing the incidence of radiation complications following plaque radiation for uveal melanoma.


Condition Intervention Phase
Uveal Melanoma
Radiation Retinopathy
Radiation Maculopathy
Drug: Ranibizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma

Resource links provided by NLM:


Further study details as provided by Shields, Shields and Associates:

Primary Outcome Measures:
  • Presence or absence of optical coherence (OCT) evidence of macular edema. [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up. [ Time Frame: 4 months ]

Estimated Enrollment: 400
Study Start Date: April 2007
Estimated Study Completion Date: April 2009
Intervention Details:
    Drug: Ranibizumab
    Intravitreal Ranibizumab 0.5mg at the time of radioactive plaque insertion
    Other Name: Lucentis
  Eligibility

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

Inclusion Criteria:

  • Age >18 years
  • new diagnosis of choroidal melanoma
  • scheduled for plaque radiotherapy at Wills Eye Health System

Exclusion Criteria:

  • Pre-existing retinal disorders (i.e. age-related macular degeneration, diabetic maculopathy, retinal vascular occlusion, macular hole, surface wrinkling retinopathy)
  • prior retinal detachment
  • media opacities precluding accurate OCT imaging
  • history of glaucoma
  • pregnancy
  • age <18 years.
  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: NCT00540930

Locations
United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Shields, Shields and Associates
Investigators
Principal Investigator: Carol L Shields, MD Wills Eye Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00540930     History of Changes
Other Study ID Numbers: 07-816
Study First Received: October 5, 2007
Last Updated: October 5, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Melanoma
Retinal Diseases
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Diseases
Eye Neoplasms
Neoplasms by Site
Uveal Diseases

ClinicalTrials.gov processed this record on July 28, 2014