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A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Uveal Melanoma, Radiation Retinopathy, Radiation Maculopathy

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Trial Information

A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

4 months

Principal Investigator

Carol L Shields, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wills Eye Institute

Authority:

United States: Institutional Review Board

Study ID:

07-816

NCT ID:

NCT00540930

Start Date:

April 2007

Completion Date:

April 2009

Related Keywords:

  • Uveal Melanoma
  • Radiation Retinopathy
  • Radiation Maculopathy
  • Melanoma
  • Retinal Diseases
  • Uveal Neoplasms

Name

Location

Wills Eye InstitutePhiladelphia, Pennsylvania  19107