A 6 MONTH, SINGLE-MASKED, MULTICENTER, RANDOMIZED, CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF 700 µg DEXAMETHASONE POSTERIOR SEGMENT DRUG DELIVERY SYSTEM APPLICATOR SYSTEM AS ADJUNTIVE THERAPY TO LUCENTIS COMPARED WITH LUCENTIS ALONE IN THE TREATMENT OF PATIENTS WITH CHOROIDAL NEOVASCULARIZATION SECONDARY TO AGE-RELATED MACULAR DEGENERATION - ND

Conditions: Patients with neovascularization choroidal secondary to age-related macular degeneration
MedDRA version: 9.1Level: LLTClassification code 10060823Term: Choroidal neovascularisation

Registration Number: EUCTR2007-004416-31-IT

Lead Sponsor: ALLERGAN UK Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. Male or female ≥ 50 years 2. In the study eye, subfoveal CNV secondary to AMD as evaluated by the investigator based on clinical examination and fluorescein angiography, with a total lesion size (including blood, scar/atrophy, and neovascularization) of ≤ 12 MPS (Macular Photocoagulation Study) disc areas (30.48 mm2), of which at least 50% has to be active CNV (classic or occult) at the screening visit 3. In the study eye, best-corrected visual acuity (BCVA) score ≥ 19 and ≤ 69 letters (approximately 20/400 and 20/40 on the Snellen scale) using the Early Treatment Diabetic Retinopathy Study (ETDRS) method at the screening visit 4. Patient requires Lucentis treatment in the opinion of the investigator. 5. Written informed consent has been obtained 6. Written authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained. 7. Written Data Protection Consent (European sites only) has been obtained 8. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable. 9. Ability 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

Study Eye 1. Presence of any subfoveal scarring, fibrosis, or atrophy 2. Any significant ocular disease other than CNV due to AMD that could compromise vision and/or confound interpretation of the data 3. Presence of any causes of CNV such as pathologic myopia (spherical equivalent of ?8 diopters or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis 4. Retinal pigment epithelium tear that includes the fovea as determined by fluorescein angiography (FA) at the screening or baseline visit 5. Significant media opacities (including cataract), inability to dilate pupil, or lack of patient cooperation that, in the opinion of the investigator, might interfere with the patient?s ocular evaluations 6. Aphakia or presence of anterior chamber intraocular lens 7. Prior pars plana vitrectomy 8. Elevated intraocular pressure (IOP) (any of the following) at the screening or baseline visit: a) IOP > 23 mm Hg if taking no IOP-lowering medications; or b) IOP > 21 mm Hg if taking one IOP-lowering medication; or c) Use of 2 or more IOP-lowering medications (combination products are considered 2 medications) Note: IOP-lowering medication usage or lack thereof must be stable for at least 6 weeks prior to the screening visit 9. Previous or anticipated concomitant therapy: 9.1 Cohort 1 a) Any previous treatment for AMD 9.2 Cohort 2 a) Foveal thermal laser treatment for AMD within 3 month prior to the screening visit b) PDT treatment for AMD within 3 months prior to the screening visit c) Intraocular treatment with Lucentis, Avastin, or Macugen within 6 weeks prior to the screening visit d) Use of topical ophthalmic corticosteroids or topical ophthalmic nonsteroidal drugs within 4 weeks prior to the screening visit e) History of any intravitreal triamcinolone acetonide injection unless the most recent dose was more than 6 months prior to the screening visit and each dose was ≤ 4 mg f) Any intravitreal or periocular dexamethasone injection within 3 months prior to the screening visit g) Periocular depot corticosteroid injection within 6 months prior to the screening visit h) If corticosteroids were previously administered, there were no corticosteroid or injection-related complications that would be expected to recur with repeated intravitreal corticosteroid administration. i) Recent (within 30 days prior to screening) or anticipated use of investigational multivitamins or trace minerals. 10. Any intraocular surgery (including cataract surgery and/or laser of any type) within 3 months prior to the screening visit 11. Anticipated need for ocular surgery or laser treatment during the study period 12. History of herpetic infection in the study eye or adnexa 13. Presence of visible scleral thinning or ectasia at the screening or baseline visit as determined by biomicroscopy Either Eye 14. Diabetic retinopathy 15. Active ocular infection (bacterial, viral, parasitic, or fungal) at the screening or baseline visit 16. Glaucoma, optic nerve head change consistent with glaucoma, or visual field loss consistent with glaucoma. 17. History of IOP elevation in response to steroid treatment that resulted in either of the following: a) IOP increase of ≥ 10 mm Hg and an absolute IOP ≥ 25 mm Hg, both attributed to the use of steroid treatment b) Required surgery, laser, or more than 1 medication to lower IOP 18. Contraindication to pupil dilation 19

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: ;Main Objective: TO evaluate the safety and efficacy of DEX PS DDS as adjunctive therapy to Lucentis (Hereafter referred to as Adjunctive therapy) compared with sham DEX PS DDS plu Lucentis (Hereafter referred to as Lucentis Alone) in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).;Primary end point(s): The primary efficacy variable is the time from the second Lucentis injection (day 7 to day 14) to the determination of elegibility to receive a third Lucentis injection. For those not requiring a third injection or for those who discontinued the study prematurely (prior to determination of eligibility to receive a third injection), the primary efficacy variable is the time between the second injection and the exit visit.

Secondary Outcome Measures