E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Corneal neovascularisation |
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E.1.1.1 | Medical condition in easily understood language |
Ingrowth of blood vessels into the cornea |
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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 | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10055665 |
E.1.2 | Term | Corneal neovascularisation |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 Bevacizumab subconjunctival injections effectiveness on corneal neovascularisation reduction after 3 monthly injections |
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E.2.2 | Secondary objectives of the trial |
•The effectiveness of bevacizumab on reducing the percentage of corneal surface occupied by neovascularization at 6 months
•The effectiveness of bevacizumab on reducing the use of corneal graft.
•The local and general toxicity of bevacizumab administered by subconjunctival way.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Patients with corneal neovascularization whatever the origin
•Patient did not receive treatment with topical corticosteroids during the month preceding inclusion.
•Patient who has been properly informed and signed consent
•Patient aged over 18
•Patient affiliated with a health insurance plan or benefit of such a regime
- Negative pregnancy test for Women at inclusion
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E.4 | Principal exclusion criteria |
•Patients who received local or general treatment of concomitant prostaglandin derivatives
•Patients with current infection of the cornea or other tissue / organ
•Women of childbearing age without contraception
•Pregnancy and Lactation
•Patient participating in another study
•Patient with contact lenses
•Patients with uncontrolled hypertension
•Patient with a history of stroke, myocardial infarction, angina pectoris, thrombophlebitis, Raynaud's phenomenon.
•Patients hypersensitive to the active substance or any excipients
•Patients hypersensitive to products of Chinese hamster ovary cells or other recombinant human or humanized antibodies.
•Patients with active bacterial eye infections, fungal, parasitic or viral infection (with the exeption of herpes)
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction higher than 30 % of the corneal surface occupied by newvessels , at 3 months, in the Bevacizumab group compared to the placebo group. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- at 3 month (one month after the third injection) |
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E.5.2 | Secondary end point(s) |
•Reduction the percentage of corneal surface occupied by neovascularization at 6 months
•Reduction of the use of corneal graft
•Local and general toxicity of bevacizumab administered by subconjunctival way
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
-At 6 month (4 months after the third injection) |
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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 | 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 | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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
| Yes |
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 | 3 |
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 | Yes |
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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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |