drugset / Trial / NCT00750399
Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I clinical trial to test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy following plaque brachytherapy for patients with choroidal melanoma using the incidence and severity of events criteria. The secondary objective is to assess the efficacy of intravitreal ranibizumab on regression of radiation retinopathy by ophthalmic examination, fundus photography, fluorescein angiography, and optical coherence tomography, as well as visual acuity.
Timeline
- Start
- 2008-10
- Primary completion
- 2011-09
- Completion
- 2011-09
Publications
- Background Finger PT. Radiation retinopathy is treatable with anti-vascular endothelial growth factor bevacizumab (Avastin). Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):974-7. doi: 10.1016/j.ijrobp.2007.11.045.
- Background Finger PT, Chin K. Anti-vascular endothelial growth factor bevacizumab (avastin) for radiation retinopathy. Arch Ophthalmol. 2007 Jun;125(6):751-6. doi: 10.1001/archopht.125.6.751.
- Results Finger PT, Chin KJ. Intravitreous ranibizumab (lucentis) for radiation maculopathy. Arch Ophthalmol. 2010 Feb;128(2):249-52. doi: 10.1001/archophthalmol.2009.376. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |