Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma
Delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery
transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy.
Administration of the drug directly to the targeted site thus avoids the complications and
adverse events associated with toxicity from systemic, rather than local, chemotherapy.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients who complete therapy without the need for additional treatment including systemic chemotherapy, external beam radiation, or enucleation.
The primary objective of this study is to show that intra-arterial delivery of the chemotherapeutic agent is successful in treating intraocular retinoblastoma, defined as avoiding systemic chemotherapy, external beam radiation, and enucleation.
Within the first six months after the initial treatment.
Monica Pearl, M.D.
The Johns Hopkins Hospital
United States: Food and Drug Administration
|The Johns Hopkins Hospital||Baltimore, Maryland 21205|