A 6-Week, Multicenter, Masked, Randomized Trial (with a 20-Week Masked Extension) to Assess the Safety and Efficacy of 700 µg and 350 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System Compared with Sham DEX PS DDS Applicator System in the Treatment of Non Infectious Ocular Inflammation of the Anterior Segment in Patients with Anterior Uveitis

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2006-000737-36-BE
• Date of registration: 15/06/2006
• Prospective Registration: Yes
• Primary sponsor: Allergan Limited
• Public title: A 6-Week, Multicenter, Masked, Randomized Trial (with a 20-Week Masked Extension) to Assess the Safety and Efficacy of 700 µg and 350 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System Compared with Sham DEX PS DDS Applicator System in the Treatment of Non Infectious Ocular Inflammation of the Anterior Segment in Patients with Anterior Uveitis
• Scientific title: A 6-Week, Multicenter, Masked, Randomized Trial (with a 20-Week Masked Extension) to Assess the Safety and Efficacy of 700 µg and 350 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System Compared with Sham DEX PS DDS Applicator System in the Treatment of Non Infectious Ocular Inflammation of the Anterior Segment in Patients with Anterior Uveitis
• Date of first enrolment: 31/08/2006
• Target sample size: 189
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000737-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Sham controlled If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Sham applicator

Countries of recruitment

Austria, Belgium, Czech Republic, Portugal, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female, at least 18 years of age
2. Diagnosis of persistent non-infectious anterior uveitis in at least one eye, based on the standardization of uveitis nomenclature for reporting clinical data workshop (SUN Working Group. AJO 2005;140:509-516). For the diagnosis of anterior uveitis (e.g. iritis, iridocyclitis, anterior cyclitis), the anterior chamber must be the primary site of inflammation.
2.1. Persistent anterior segment inflammation defined as lasting > 3 months prior to the time of the screening visit
2.2. Patients with secondary posterior segment inflammation (e.g., anterior vitreous cell, mild vitreous haze, peripheral vasculitis, optic nerve edema, or cystoid macular edema) are eligible if, in the opinion of the investigator, the anterior segment inflammation is the principal source of posterior segment inflammation
3. Anterior chamber cell score of at least +2 at both the screening (Days -14 to -4) and baseline (Day -4 to 0) visits in the study eye despite topical corticosteroids at least three times a day for at least two weeks prior to baseline
4. Best-corrected ETDRS visual acuity score at screening and baseline of = 35 letters (i.e. Snellen equivalent of approximately 20/200 or better) 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 or NSAIDs if on stable doses of at least three times a day for at least 2 weeks prior to screening and remain stable through treatment (Day 0)
6.2 Systemic immunosuppression if doses are stable for at least 3 months prior to screening and remain stable through treatment (Day 0)
6.3 Systemic corticosteroids if daily 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:
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
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 visit
5. Known allergy or sensitivity to the study medications, any component of the delivery vehicle, any corticosteroid, 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 6 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 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 in the study eye that can interfere with the diagnosis or the assessment of disease progression such as corneal edema, posterior synechiae, iris or angle neovascularization
11. Periocular corticosteroid injections to the study eye = 16 weeks prior to the treatment visit
12. History of any intravitreal drug injection to the study eye = 26 weeks prior to the treatment visit
13. 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 = 4 mg
14. Any previous use of RetisertTM (fluocinolone acetonide intravitreal implant) in the study eye
15. Intr

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Non-infectious ocular inflammation of the anterior segment in anterior uveitis

Intervention(s)

Product Name: DEX PS DDS Applicator System
Product Code: 9632X
Pharmaceutical Form: Implant
INN or Proposed INN: dexamethasone
CAS Number: 50-02-2
Current Sponsor code: AGN206207
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 700-
Route of administration of the placebo: Route of administration not applicable

Product Name: DEX PS DDS Applicator System
Product Code: 9635X
Pharmaceutical Form: Implant
INN or Proposed INN: dexamethasone
CAS Number: 50-02-2
Current Sponsor code: AGN206207
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 350-
Route of administration of the placebo: Route of administration not applicable

Primary Outcome(s)

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 anterior segment in patients with anterior 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 anterior segment in patients with anterior uveitis

Primary end point(s): The primary efficacy variable is the anterior chamber cell score measured by biomicroscopy and based on the cell count, as follows:
0 = 0 cells*
+0.5 = 1 – 5 cells (trace)**
+1 = 6 – 15 cells
+2 = 16 – 25 cells
+3 = 26 – 50 cells
+4 = > 50 cells

Note hypopyon if present.

* Rare cells, defined as < 1 cell seen per field, should be graded as zero
** Record actual cell count on Case Report Form for +0.5 grade only

There is no primary safety endpoint for the study.

Secondary ID(s)

206207-015

2006-000737-36-GB