Radiation retinopathy in eyes treated with Iodine 125 plaque radiotherapy for posterior uveal melanoma MedDRA version: 9.1 Level: LLT Classification code 10064714 Term: Radiation retinopathy
Conditions
Interventions
Trade Name: Lucentis
Product Name: Lucentis
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lucentis
Other descriptive name: Ranibizumab
Concentration unit: mg/ml milligram(s)/millili
Sponsors
Cliniques Universitaires St Luc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male of female patients above 18 years of age who have signed an informed consent The eye received Iodine 125 plaque radiotherapy for posterior uveal melanoma 12 months ago with tumor apex dose of 75 Gy Tumor characteristics at the time of treatment of the melanoma 12 months ago : - posterior uveal melanoma without ciliary body and iris involvement - tumor posterior margins lower or equal to 3 mm to the fovea - largest tumor diameter equal or above 10 and 16 mm - tumor thickness equal or above 4 mm and equal or lower than 8 mm - radiation doses rate of greater than 260 cGy /h to the tumor base Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with diabetes type I and II Active intraocular inflammation in either eye Any active infection (i.e. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis) in either eye Ocular conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroïd Following ocular disorders in the study eye are not allowed : branch retinal vein occlusion, branch retinal arterial occlusion, vitreous hemorrhage, and choroïdal neovascularisation of any cause (e.g.AMD, ocular histoplasmosis, or pathologic myopia) Presence of macular subretinal fluid documented by OCT Neovascular glaucome in the study eye Known hypersensitivity to ranibizumab or any component of the formulation Pregnant or nursing women Inability to comply with study of follow-up procedure Women of child-bearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the effect of ranibizumab (0,5 mg) on central retinal thickness from baseline to 12 months treatment of ranibizumab;Secondary Objective: To evaluate the effect of ranibizumab (0,5 mg) on central retinal thickness after 3 months,6 months and 9 months treatment of ranibizumab To evaluate the effect of ranibizumab(0,5 m) on the occurance of mild to moderate foveolar cystoïd edema(grade 4) and severe cystoïd foveolar edema(grade 5) To evaluate the pourcentage of patients evolving to poor vision at month 12, defined as visual acuity of 20/200 or worse To describe the proportion of patients after 12 months ranibizumab treatment with loss of 15 or more letters of visual acuity versus baseline To evaluate the effect of ranibizumab(0,5 mg) on anatomical changes within a diameter of 3 mm around the fovea, relative to radiation retinopathy after 3,6,9, and 12 months treatment with ranibizumab and documented by FA and or OCT ;Primary end point(s): To evaluate effects of ranibizumab 0,5 mg on central retinal thickness from baseline to 12 months treatment of ranibizumab | — |
Countries
Belgium
Outcome results
None listed