Abstract
Purpose: :
To evaluate the safety and tolerability of High dose Ranibizumab + CSTIP for the treatment of Choroidal Melanoma
Methods: :
A prospective, longitudinal, non-randomized, case-control study was designed. Patients were recruited in a single center for an open-label, active treatment of CSTIP (Combined simultaneous Transpupillary thermotherapy - ICG enhanced PDT) + intravitreal (IV) Ranibizumab (0.5 versus 2 mg). All the patients were 18 years old or older with a small or medium size choroidal melanoma. In every visit, each patient underwent a complete ophthalmological evaluation. The tumor activity was evaluated with Fluorescein angiogram and B-scan ultrasonography. Outcome measures were best corrected visual acuity and tumor activity.
Results: :
Eight patients met the inclusion criteria. Four males and 4 females. Patients have completed at least 6 months of follow-up. All patients received 2 CSTIP. Four patients received 6 IV injections of 0.5 mg of Ranibizumab, and the other 4 patients received 3 IV injections of 2 mg of Ranibizumab. Mean age was 69 year old in both groups. The laterality was variable. The mean number of CSTIP required to control the tumor locally was 2.5 in the high dose group and 2 in the standard dose group. There were not complications associated. Visual acuity was stabilized in 80% of patients.
Conclusions: :
Ranibizumab does not reduce the number of CSTIP treatments needed to achieve local control of the tumor. However, it does help to maintain visual acuity. This secondary effect may be related to a better perfusion of the treated and surrounding areas of the retina.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00680225
Keywords: melanoma • vascular endothelial growth factor • laser