A one year, open, prospective study on the role of quarterly intravitreal injections of Lucentis 0,5 mg (ranibizumab) in preventing of delaying progression of radiation retinopathy in eyes treated with Iodine 125 plaque radiotherapy for posterior uveal melanoma</full-title-trial

Conditions: Radiation retinopathy in eyes treated with Iodine 125 plaque radiotherapy for posterior uveal melanoma
MedDRA version: 9.1Level: LLTClassification code 10064714Term: Radiation retinopathy

Registration Number: EUCTR2008-008720-33-BE

Lead Sponsor: Cliniques Universitaires St Luc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

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

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