Topotecan transscleral chemoplaque for retinoblastoma
Sponsor: |
3TOphthalmics |
Enrolling: |
Male and Female Patients |
Study Length: |
100 Days |
Clinic Visits: |
5 |
IRB Number: |
AAAU1956 |
Contact: |
Marzhan Atakulova: 212-305-0011 / ma3448@cumc.columbia.edu |
In this research study we want to learn more about treatment of advanced or recurrent retinoblastoma. For children with retinoblastoma that have an advanced stage of presentation in one eye or if they have failed all conventional treatment, eye removal is considered. This study will investigate the utility of a chemoplaque(s) to salvage eyes involved with retinoblastoma. Chemoplaque is a device that is implanted on the surface of the eye and it releases chemotherapy over a period of time. The goal of the study is to further determine/assess the safety and efficacy and optimal chemotherapy dosage for retinoblastoma. The chemoplaque will be placed following the first exam under anesthesia and this involves a surgery wherein the disc that will release the chemotherapy medication would be placed under the conjunctiva (surface lining of the eye) and will be glued with tissue glue to the sclera (coating of the eye).The chemoplaque will remain in the eye till day 42 when the chemoplaque will be removed.Eye exam under anesthesia will be performed on Day 0, Day 21, Day 42 and Day 42 (prior to chemoplaque removal).Blood will be drawn periodically for testing the blood parameters (CBC) and to evaluate toxicity of the medication.Study subjects will be followed till Day 84 when the trial will be completed.
This study is closed
Investigator
Brian Marr, MD
Children under 8 years |
Yes |
No |
Diagnosed with retinoblastoma |
Yes |
No |