E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with corneal neovascularization, a major risk factor of corneal graft rejection. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with vessels growing in their cornea of the eye that decreases visual acuity |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
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 |
To demonstrate clinical benefit on visual acuity (VA). |
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E.2.2 | Secondary objectives of the trial |
To demonstrate regression and inhibition of additional corneal angiogenesis with GS-101 eye drops in patients suffering from keratitis or kerato-uveitis of bacterial , viral (e.g. herpes), or traumatic (e.g. alkali burns) origin leading to potentional corneal graft indication.
To demonstrate additional clinical benefit on quality of life (QoL), need for transplantation, and risk of graft rejection after potential future transplantation.
To assess the safety and tolerability of GS-101. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Men or non-pregnant women (only women who are post-menopausal, surgically sterile or practicing a reliable contraception).
At least 18 years old.
Suffering from keratitis or kerato-uveitis of bacterial, viral (e.g. herpes), or traumatic (e.g. alkali burns) origin.
Evidence of documented progression of stromal neovascularization during a minimum period of 1 week and maximum of 2 months and corneal vessels reaching out for at least 2,5 mm from the limbus and/or reaching the cornea center.
Visual acuity >.01 and < 1.0
Patients who are able to understand the protocol and give informed consent. |
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E.4 | Principal exclusion criteria |
Pregnancy: a urinary test for pregnancy must be performed in female patients before inclusion in the study.
Patients who cannot communicate reliably with the investigator.
Patients who are unlikely to cooperate with the requirements of the study.
Patients who are unwilling and/or unable to give informed consent.
Patients suffering from a life-threatening progressive disease.
Patients participating in another clinical study
Patients who have used any other investigational drugs within 1 month of first dosing. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At screening, inclusion and after 1, 3 and 6 months |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At screening, inclusion and after 1, 3 and 6 months |
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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 | Yes |
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 | Yes |
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
| 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |