Treatment Of Radiation Retinopathy Trial

Sponsor
Leiden University Medical Center
Study ID
NCT00811200
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ranibizumab — DRUG
    three initial monthly intra vitreal injections with 0.5 mg ranibizumab
  • triamcinolone acetonide — DRUG
    at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide
  • sham — OTHER
    at baseline one sham-injection

Study Details

The purpose of this study is to demonstrate a statistically significant improvement of visual acuity after treatment using either Lucentis® or Triamcinolone® compared to no treatment, in patients with radiation retinopathy.

Key Dates

First listed
Dec 18, 2008
Start date
Sep 30, 2009
Status verified
Jun 2009
Primary completion
Jan 31, 2012

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1: Lucentis
  • Active Comparator: 2: Kenalog
  • Sham Comparator: 3: No treatment

Primary Outcome Measure

To demonstrate a statistically significant superiority of intravitreal ranibizumab (0.5mg) or triamcinolone acetonide (4.0mg) to no treatment, in the mean change from baseline in best corrected visual acuity (BCVA) [ Time Frame: one year ]

Central Contacts

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