Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

NCT00540930 | Unknown Phase 4 DMC

• 1 other identifier: 07-816
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uveal Melanoma; Radiation Retinopathy; Radiation Maculopathy

Outcome Measures

Primary Outcomes (1)

• Presence or absence of optical coherence (OCT) evidence of macular edema.

  4 months

Secondary Outcomes (1)

• Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up.

  4 months

Interventions

Ranibizumab DRUG

Intravitreal Ranibizumab 0.5mg at the time of radioactive plaque insertion

Also known as: Lucentis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shields, Shields and Associates: lead

Study Sites (1)

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Carol L Shields, MD

  Wills Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: April 1, 2007
• Study Completion: April 1, 2009
• Last Updated: October 8, 2007

Record last verified: 2007-10

Locations

US (1)