Non-infectious ocular inflammation of the posterior segment in intermediate or posterior uveitis
Conditions
Sponsors
Allergan Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, at least 18 years of age 2. Diagnosis of intermediate or posterior 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). For diagnosis of intermediate uveitis (e.g. pars planitis, posterior cyclitis, hyalitis), the vitreous must be the primary site of inflammation. The presence of peripheral vascular sheathing and macular edema is acceptable as long as the vitreous remains the main site of inflammation. For diagnosis of posterior uveitis, the retina or choroid must be the primary site of inflammation. Suspected masquerade syndromes should be ruled out by the investigator prior to patient entry into the study 3. Vitreous haze of at least +1.5 at both the screening and baseline visits in the study eye 4. Best-corrected ETDRS visual acuity score of 10 to 75 letters inclusive (Snellen equivalent approximately 20/640 – 20/32) at screening and baseline visits in the study eye 5. Media clarity other than vitreous haze, pupillary dilation, and patient cooperation sufficient for adequate visualization of the optic nerve in the study eye 6. Allowable treatments at screening, baseline, and treatment (Day 0) visits: 6.1. Topical corticosteroids and NSAIDs (e.g. ketorolac, diclofenac) if doses are stable for at least 2 weeks prior to screening and remain stable through treatment (Day 0) 6.2. Systemic immunosuppression (e.g., cyclosporine, methotrexate) if doses are stable for at least 3 months prior to screening and remain stable through treatment (Day 0) 6.3. Systemic corticosteroids if doses are =20 mg/day oral prednisone (or equivalent), are stable for at least 1 month prior to screening and remain stable through treatment (Day 0) 6.4. Topical cycloplegia (e.g. homatropine, atropine) at the investigator’s discretion 7. Female patients of childbearing potential must have a negative urine pregnancy test at the treatment (Day 0) visit 8. Written informed consent has been obtained 9. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained 10. Written Data Protection Consent (European sites only) has been obtained 11. Written documentation has been obtained in accordance with state and country privacy requirements, where applicable 12. Ability to understand the informed consent and willingness to follow study instructions and likely to complete all required visits and procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General exclusion criteria: 1. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception 2. Uncontrolled systemic disease or known human immunodeficiency virus (HIV) infection 3. Participation in an investigational trial within 30 days of study entry 4. Use of warfarin/heparin/enoxaparin or similar anticoagulant agent = 2 weeks prior to the treatment (Day 0) visit 5. Known allergy or sensitivity to the study medication(s), any component of the delivery vehicle, any corticosteroids or any diagnostic agents used during the study (e.g. fluorescein, dilation drops) 6. Anticipated need to initiate or change doses of current systemic immunosuppression or systemic corticosteroids during the first 8 weeks of the study 7. Any condition (including inability to read visual acuity charts or language barrier) that precludes patient’s ability to comply with study requirements including completion of the study 8. Patient has a condition or is in a situation that in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study Ocular exclusion criteria: 1. Previous enrollment in a DEX PS DDS clinical trial 2. IOP > 21 mm Hg at screening or baseline 3. 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 =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 4. 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 5. Use of anti-glaucoma medications in the study eye within 4 weeks prior to the screening visit or any use between screening and treatment visits 6. History of central serous chorioretinopathy in either eye 7. Any active ocular infection (i.e. bacterial, viral, parasitic, or fungal) in either eye at screening, baseline, or treatment visits 8. Presence of active or inactive toxoplasmosis in either eye 9. Contraindication to pupil dilation in either eye 10. 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 11. Periocular corticosteroid injections to the study eye = 8 weeks prior to the treatment visit 12. History of any intravitreal drug injection to the study eye = 26 weeks prior to the treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of the 700 µg DEX PS DDS Applicator System (700 µg dexamethasone) and 350 µg DEX PS DDS Applicator System (350 µg dexamethasone) 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 or posterior uveitis;Secondary Objective: To evaluate the safety and efficacy of the 700 µg DEX PS DDS Applicator System (700 µg dexamethasone) compared with the 350 µg DEX PS DDS Applicator System (350 µg dexamethasone) in the treatment of non-infectious ocular inflammation of the posterior segment in patients with intermediate or posterior uveitis; Primary end point(s): The primary efficacy variable is vitreous haze. The ophthalmologist will grade vitreous haze by viewing the optic disc and posterior retina using an indirect ophthalmoscope set to large beam and mid power illumination with a 20-diopter lens. Low ambient lighting and the same indirect ophthalmoscope should be used whenever possible. The view will be compared against a photographic scale according to the chart provided by Allergan. The scale is based on the following unit scale categorized as follows: 0 = No inflammation +0.5 = Trace inflammation (slight blurring of the optic disc margins and/or loss of the NFL reflex) +1 = Mild blurring of retinal vessels and optic nerve +1.5 = Optic nerve head and posterior retina view obscuration greater than +1, but less than +2 +2 = Moderate blurring of optic nerve head +3 = Marked blurring of optic nerve head +4 = Optic nerve head not visible There is no primary safety endpoint for the study | — |
Countries
Austria, Belgium, Czech Republic, Germany, Greece, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed