Medpedia

Treatment With Intravitreal Avastin for Large Uveal Melanomas

Completed
04/01/2007 to 06/01/2008
10
N/A
Interventional

Conditions

  • Uveal Melanoma

Eligibility

18 and older
No
Inclusion Criteria:
- Patients diagnosed with large uveal melanomas who elect to undergo enucleation.
- Patients diagnosed with uveal melanomas with tumor thickness > 10 mm or basal
diameter > 16 mm, as measured by ultrasound examination, funduscopic examination, or
transillumination.
Exclusion Criteria:
- Cases that do not meet the above criteria for tumor size will be ineligible to
participate in the study.
- Patients with history of metastatic cancer (other than melanoma).
- Patients not able to provide consent for the study.
- Patients with clinical or radiographic evidence of extraocular extension of the
tumor.
- Patients with a previous history of an adverse reaction to intravitreal injection.
- Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
- Patients with intravitreal silicone oil or gas tamponade.
- Patients < 18 years of age.
- Women known to be pregnant.

Purpose


Interventions

  • Drug: AVASTIN
    a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.

Outcome Measures

  • To examine the response of intravitreal Avastin in causing a clinically significant reduction in uveal melanoma tumor size (base height and volume).
    conclusion of study
    Safety Issue: No
  • To examine the short-term safety profile of intravitreal injection of Avastin in patients with intraocular tumors.
    conclusion of study
    Safety Issue: Yes

Locations

  • Memorial Sloan Kettering Cancer Center
    New York, New York, 10065, United States
    Completed

Sponsors

  • Memorial Sloan-Kettering Cancer Center
    Lead Sponsor
  • United States: Institutional Review Board

Links

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