Abstract
Purpose: :
To evaluate the safety and efficacy of SHIP + High dose Ranibizumab versus SHIP + standard Ranibizumab for the treatment of Choroidal Melanoma.
Methods: :
The study was done in a clinical practice setting. Prospective, randomized, off label study.Ten eyes of 10 patientes with small or medium size choroidal melanomas were selected. All patients were treated with Simultaneous hyperthermia and ICG-enhanced Photodynamic Therapy (SHIP). Patients were subdivided to receive 0.5 mg or 2 mg of intravitreal Ranibizumab. SHIP was performed using an infrared light delivered from a diode laser. Ranibizumab was injected in a standard sterile fashion. All patients were evaluated to rule out metastasis and underwent a complete ophthalmological evaluation including: Dilated fundus examination, fluorescein angiography (FA), SD-Optical coherence tomography (OCT) and A/B-scan ultrasonography (US). Tumor activity was evaluated with FA and US. SD-OCT was performed to rule out macular complications. Main outcome measures were visual acuity, local control of the tumor and rate of complications.
Results: :
Ten patients were studied with a mean age of 68.5 years (range from 55-78). All patients received SHIP (transpupillary thermotherapy + ICG enhanced photodynamic therapy). Six patients were treatment naïve, and 4 patients had a recurrent tumor, which was initially treated with SHIP (series of 3). The mean time for recurrence in these 4 patients was 5.3 years. In the group receiving 0.5 mg of Ranibizumab, the mean number of SHIP was 3. In the group receiving 2 mg of Ranibizumab, the mean number of SHIP was 6.7. All the patients received a cumulative dose of 6 mg of Ranibizumab as adjuvant treatment.Local control of the tumor was achieved in all cases. />Complications included subconjunctival hemorrhage, cystoid macular edema, peripheral branch retinal vein occlusion, epiretinal membrane and rhegmatogenous retinal detachment. All the complications were related to the laser treatment and not to the intravitreal injection. Their incidence did not affect the control of the disease.Visual acuity was variable with no statistically difference in both groups. In the high dose group the baseline VA was 20/50 and 20/25 in the standard dose group.
Conclusions: :
Ranibizumab did not appear to decrease the number of SHIP treatments required for local erradication of the tumor. However, patients treated with adjunctive intravitreal ranibizumab had a significant better visual acuity results than those treated with SHIP alone, regardless of the dose used.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01251978
Keywords: melanoma • vascular endothelial growth factor • tumors