E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Radiation retinopathy in eyes treated with Iodine 125 plaque radiotherapy for posterior uveal melanoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064714 |
E.1.2 | Term | Radiation retinopathy |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate effects of ranibizumab 0,5 mg on central retinal thickness from baseline to 12 months treatment of ranibizumab |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |