Choroidal neovascularization secondary to age-related macular degeneration
Conditions
Interventions
Product Name: Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System
Product Code: 9632X
Pharmaceutical Form: Implant
INN or Proposed INN: Dexamethasone
CAS Number: 50-02-
Sponsors
Allergan Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: OCULAR 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) at the screening or baseline 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. History of central serous chorioretinopathy 20. Presence of active or inactive toxoplasmosis NON-OCULAR EXCLUSION CRITERIA 21. History or current uncontrolled systemic disease at the screening or baseline visits 22. Myocardial infarction or stroke within 12 months prior to the baseline visit 23. Any major surgical procedure within 1 month prior to the screening visit or during the screening period 24. Kno
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of DEX as adjunctive therapy to Lucentis® (hereafter referred to as “Adjunctive Therapy”) compared with sham DEX plus Lucentis® (hereafter referred to as “Lucentis Alone”) in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD);Secondary Objective: ;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 eligibility 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. | — |
Countries
France, Italy, Portugal, United Kingdom
Outcome results
None listed