E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022557 |
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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 evaluate the safety and efficacy of the 700 g dose and the 350 g dose DEX PS DDS Applicator Systems 700 g dexamethasone and 350 g dexamethasone DEX PS DDS, respectively compared with Sham DEX PS DDS Applicator System needle-less applicator in the treatment of non-infectious ocular inflammation of the posterior segment in patients with intermediate uveitis. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and efficacy of the 700 g DEX PS DDS Applicator System 700 g dexamethasone compared with the 350 g DEX PS DDS Applicator System 350 g dexamethasone in the treatment of non-infectious ocular inflammation of the posterior segment in patients with intermediate uveitis. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male or female, at least 18 years of age Diagnosis of intermediate uveitis in at least one eye based on the standardization of uveitis nomenclature for reporting clinical data workshop. SUN Working Group classification report published AJO 2005; 140 509-516 . Suspected masquerade syndromes should be ruled out by the investigator prior to patient entry into the study Vitreous haze of at least 2 at both the screening and baseline visits in the study eye Best-corrected ETDRS visual acuity score of 35 to 68 letters inclusive Snellen equivalent approximately 20/40 20/200 at screening and baseline visits in the study eye Media clarity other than vitreous haze, pupillary dilation, and patient cooperation sufficient for adequate visualization of the optic nerve in the study eye |
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E.4 | Principal exclusion criteria |
Ocular exclusion criteria Previous enrollment in a DEX PS DDS clinical trial IOP 21 mm Hg at screening or baseline History of clinically significant IOP elevation in response to corticosteroid treatment in either eye defined as an increase of 10 mm Hg and an absolute IOP of 8805;25 mm Hg without the use of anti-glaucoma medications unless there is a functioning trabeculectomy or seton with IOP 18 mm Hg at screening and baseline and there is no significant visual field loss in the investigator s opinion History, diagnosis, or clinical findings of ocular hypertension or glaucoma e.g. elevated IOP, optic nerve head change consistent with glaucoma, glaucomatous visual field loss in the study eye unless there is a functioning trabeculectomy or seton with IOP 18 mm Hg at screening and baseline and there is no significant visual field loss in the investigator s opinion. Patients with a history of episodic increases in IOP due to inflammation and not due to corticosteroids may be eligible if they meet all other IOP and glaucoma medication exclusions Use of anti-glaucoma medications within 4 weeks prior to the screening visit or any use between screening and treatment visits History of central serous chorioretinopathy in either eye Any active ocular infection i.e. bacterial, viral, parasitic, or fungal in either eye at screening, baseline, or treatment visits Presence of active or inactive toxoplasmosis in either eye Contraindication to pupil dilation in either eye Any other ocular disease e.g. choroidal neovascularization, media opacity in the study eye that can interfere with the diagnosis or the assessment of disease progression Periocular corticosteroid injections to the study eye 8804; 16 weeks prior to the treatment visit History of any intravitreal drug injection to the study eye 8804; 26 weeks prior to the treatment visit History of any intravitreal corticosteroid injection to the study eye unless all of the following criteria are met a. The only corticosteroid injected intravitreally was triamcinolone acetonide b. The most recent dose was 26 weeks prior to the treatment visit c. All doses were 8804;4 mg Any previous use of RetisertTM fluocinolone acetonide intravitreal implant in the study eye Intraocular surgery, including cataract surgery, and/or laser of any type in the study eye 8804; 90 days prior to the treatment visit Aphakia or anterior chamber intraocular lens in the study eye posterior chamber IOL is acceptable History of pars plana vitrectomy in the study eye History of herpetic infection in the study eye or adnexa Presence of visible scleral thinning or ectasia in the study eye at screening, baseline, or treatment visits Best-corrected ETDRS visual acuity score 34 letters approximately 20/200 on the Snellen scale in the non-study eye using the ETDRS method at the screening or baseline visit Uveitis expected to be unresponsive to corticosteroids or uveitis unresponsive to prior corticosteroids Hypotony IOP 5 mm Hg or clinical signs such as choroidals, choroidal or corneal folds or pre-phthisis e.g. scleral thickening on ultrasonography, decreasing globe size |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy assessment will be on the ocular inflammation in the study eye as measured by vitreous haze on a standardized 0 to 4 scale 0, 0.5, 1, 2, 3, 4 . The primary efficacy analysis will be performed on the change from the baseline in vitreous haze using the ITT population. Missing data will be imputed using the last observation carried forward LOCF method. Efficacy analyses will be performed at all scheduled efficacy visits with week 8 being the primary time point for the efficacy analyses. |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Piu trattamento simulato uso dell aplicatore ; |
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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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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 | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |