N/A
N=1
Treatment With Intravitreal Avastin for Large Uveal Melanomas
Uveal Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00596362 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume). — 1; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AVASTIN (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume). |
1; 0; 0; 0 | — |
Summary
The purpose of this study is to test the safety and effectiveness of Avastin introduced into the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye). Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00596362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.