E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-infectious Uveitis affecting posterior segment of the eye |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 4.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036370 |
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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 |
To observe the safety of the intravitreal fluocinolone acetonide (FA) (0.59 mg) implant in the management of patients with non-infectious uveitis affecting the posterior segment of the eye who were previously treated successfully with an intravitreal FA (0.59 mg ) implant for approximately 30 months and are seeking treatment by means of replacement of the original study implant with a second FA implant. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients must meet the following criteria to be eligible for enrollment:
Implanted patients who have completed approximately 30 months in the 415-002 trial and have experienced a recent recurrence of uveitis, and in the opinion of the Investigator and the Bausch & Lomb Medical Monitor, would benefit from a replacement implant.
AND AT THE TIME OF IMPLANTATION, THE STUDY EYE MUST HAVE:
< 10 anterior chamber cells (A/C) /high-powered field (HPF) and vitreous haze <2 NOTE: Patients may be treated prior to entry in order to qualify. The objective is to obtain a relatively quiet eye prior to surgery for implantation of implant. All eyes must satisfy this requirement. |
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E.4 | Principal exclusion criteria |
Patients are not eligible for enrollment in this study if any of the following are applicable:
1. Patient who was randomized in the standard of care group in BLP415-002 study
2. Patient whose previous FA implant was removed due to uncontrolled IOP
3. Presence of vitreous hemorrhage
4. Presence of a recent toxoplasmosis scar in the eye
5. Peripheral retinal detachment
6. Media opacity precluding evaluation of the retina and vitreous
7. Intraocular pressure (IOP) increase to > 25 mmHg that could not be reduced to 21 mmHg or less by either medical or surgical means.
An IOP increase requiring medical or surgical intervention must have a successful outcome (reduction to 21 mmHg or less) lasting at least 3 months prior to enrollment.
9. Ocular surgery and /or trauma on the study eye within 3 months prior to enrollment or trabeculoplasty or YAG laser within one month prior to enrollment
10. Female pregnant, lactating, or of childbearing potential considering becoming pregnant during the course of the study and those not taking effective contraception/precautions to avoid pregnancy
11. Patient for whom, in the physician’s opinion, any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study.
12. Uveitis of infectious etiology
13. Patient who has been tested positive for human immunodeficiency virus.
14. Patient who is currently enrolled in any other clinical study or who has participated in any clinical study other than BLP415-002 within 1 month of enrollment. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of the safety of a second implant |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
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 | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |