Abstract
Purpose: :
To evaluate safety and tolerability of Ranibizumab + TTT - ICG based PDT for Treatment of Choroidal Melanoma (CM).
Methods: :
8 consented patients have met inclusion criteria. A complete ophthalmological evaluation were performed, including A-B scan and FA examination proven small and medium size CM. Patients have been recruited in a single-center for a non-randomized, open-label, active treatment study of intravitreal Ranibizumab combined with TTT + ICG-based PDT. Systemic evaluation by a PCP included chest X-ray, serum liver enzyme levels, and abdominal CT. All cases receive 0.5 mg ranibizumab every 30 days (+/- 7 days) per 6 months and one or a maximum of two sessions of TTT at the 1st and 2nd month respectively, with follow-upv(F/U) every 4 weeks during first 7 months. Outcome measures are regression of vessels and decrease in tumor size or appearance documented by fundus pictures, FA, OCT and A-B scan, VA changes and adverse events.
Results: :
2 males, 6 females. 2 patients have completed 12 months of F/U, the others have more than 6 months of F/U. The median age was 69.25 years. The patients received a mean range of 6 intravitreal injections during F/U and 1.25 session of TTT. VA was very stable as well as OCT findings. Complications were subconjunctival hemorrhage at the injection site in 8 patients, CME in one patient and other patient revealed perivascular hemorrhage after laser. One patient showed lost of VA because the tumor lesion was close to the fovea. A scan showed increased reflectivity and B scan revealed decreased tumor size. Systemic adverse events or recurrence were not seen.
Conclusions: :
The combined treatment of CM seems to be safe, tolerable and effective achieving local tumor control, but further studies and longer F/U are needed..
Clinical Trial: :
www.clinicaltrials.gov NCT00680225
Keywords: vascular endothelial growth factor • tumors • laser