Treatment With Intravitreal Avastin for Large Uveal Melanomas

Study Overview
=================
Brief 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.

Official Title
-----------------
Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas

Conditions
-----------------
Uveal Melanoma

Intervention / Treatment
-----------------
* Drug: AVASTIN


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AVASTIN | Drug: AVASTIN<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume). | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease: neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for partial response nor sufficient increase in the sum of the longest diameter of target lesions to qualify for progressive disease | At conclusion of study, up to 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eye, Melanoma, Avastin