E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with retinopathy, due to irradiation in uveal melanoma |
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E.1.1.1 | Medical condition in easily understood language |
Retinopathy is a general term that refers to some form of persistent (i.e. inflammation) or acute (i.e. photon beam radiation) damage to the retina of the eye |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10064714 |
E.1.2 | Term | Radiation retinopathy |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate superiority of ranibizumab 0.5 mg to laser treatment regarding change from baseline in BCVA over a 6-month treatment period |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints: • Change from baseline in macular thickness and the size of areas of macular and peripheral capillary drop out over 6 months (area under the curve / 6 months) • Change from baseline in BCVA, macular thickness and the size of areas of macular and peripheral capillary drop out over 12 months (area under the curve / 12 months) • Proportion of patients with improvement of visual acuity after 6 and 12 months • Rate of vitreous hemorrhages
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Clinical signs of radiation retinopathy (cotton wool spots, hemorrhages, vascular ischemia) • Visual impairment due to focal or diffuse radiation induced ME in the irradiated eye that is eligible for laser treatment • Age ≥18 years • BCVA less than 20/32
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E.4 | Principal exclusion criteria |
• Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent VA improvement, e.g. tumor recurrence, tumor growth underneath the macula • Endoresection and / or previous vitrectomy • Patients with proliferative retinopathies or macular edema due to reasons other than irradiation: e.g. diabetic retinopathy, vein occlusion, or Irvine-Gass syndrome • Treatment with anti-angiogenic drugs or intravitreal corticosteroids or any other investigational drug within 3 months prior to randomisation • Prior laser photocoagulation treatment within 3 months (focal / grid laser) or 6 months (panretinal) prior to study entry
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in BCVA over 6 months (area under curve / 6 months) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
change after 6 months from baseline |
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E.5.2 | Secondary end point(s) |
• Change from baseline in macular thickness and the size of areas of macular and peripheral capillary drop out over 6 months (area under the curve / 6 months) • Change from baseline in BCVA, macular thickness and the size of areas of macular and peripheral capillary drop out over 12 months (area under the curve / 12 months) • Proportion of patients with improvement of visual acuity after 6 and 12 months • Rate of vitreous hemorrhages
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
change after 6 and 12 months from baseline |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
observer masked trial design |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard laser treatment of radiation retinopathy |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | No |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |