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Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

Primary Purpose

Uveal Melanoma, Radiation Retinopathy, Radiation Maculopathy

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
Shields, Shields and Associates
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Uveal Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wills Eye Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2007
Last Updated
October 5, 2007
Sponsor
Shields, Shields and Associates
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1. Study Identification

Unique Protocol Identification Number
NCT00540930
Brief Title
Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy
Official Title
A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shields, Shields and Associates

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma, Radiation Retinopathy, Radiation Maculopathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Intravitreal Ranibizumab 0.5mg at the time of radioactive plaque insertion
Primary Outcome Measure Information:
Title
Presence or absence of optical coherence (OCT) evidence of macular edema.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol L Shields, MD
Organizational Affiliation
Wills Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

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