Role of imaging in the evaluation of anatomic alterations in neovascular Age-Related Macular Degeneration (AMD) subjects: 18 month study of Fovista® (anti-PDGF therapy) administered in combination with anti-VEGF therapy
- Conditions
- Subfoveal choroidal neovascularization secondary to Age-Related Macular Degeneration (AMD)MedDRA version: 18.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disordersMedDRA version: 18.0 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2015-000519-42-FR
- Lead Sponsor
- OPHTHOTECH CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 32
Ophthalmic Inclusion Criteria:
The following inclusion criteria apply to the study eye:
- Best corrected visual acuity in the study eye between 20/40 and 20/200, inclusive. The VA must be re-confirmed at Day 1 prior to randomization.
- Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be = 9 disc areas (DA)
- Presence of subfoveal Active CNV. Active CNV” is defined as presence of fluorescein leakage consistent with choroidal neovascularization.
- Sub or intraretinal fluid in the anatomic fovea by OCT
- Clear ocular media and adequate pupillary dilatation to allow collection of fundus photographs and fluorescein angiograms of a sufficient quality to be analyzed by the central reading center.
- Intraocular pressure (IOP) of 21 mmHg or less
- Treatment naïve subjects or treatment experienced subjects which is defined as subjects with 2 prior sequential monthly doses of intravitreal anti-VEGF therapy given within the past 12 weeks. For treatment experienced subjects, there must be a VA change of = 0 letters per Snellen VA score since the last anti-VEGF injection.
General Inclusion Criteria:
- Subjects of either gender aged =50 years.
- Women must agree to be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication.
- Provide written informed consent.
- Ability to comply with study and follow-up procedures and return for all trial visits.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
Ophthalmic Exclusion Criteria:
- Intravitreal treatment (including intravitreal corticosteroids) in the study eye prior to the Day 1 visit, regardless of indication, with the exception of two prior anti-VEGF injections for the Treatment Experienced cohort.
- Subjects with atrophy or scar within 1 disc area (DA) of the center of the fovea are excluded.
- Presence of significant serous pigment epithelial detachments (PEDs), such as large PEDs that constitute greater than 50% of the total lesion or have a vertical height of = 600 µm.
- Presence of pure PED without subretinal hyper-reflective material.
- Presence of pigment epithelial tears or rips.
- Presence of intraocular inflammation, significant epiretinal membrane (causing distortion of macular anatomy and/or opacification), significant vitreomacular traction (causing distortion of macular anatomy), macular hole (full or partial thickness) or vitreous hemorrhage.
- Aphakia or absence of the posterior capsule. Absence of an intact posterior capsule is allowed if it occurred as a result of YAG laser posterior capsulotomy in association with prior posterior chamber IOL implantation.
- History of idiopathic or autoimmune-associated uveitis in either eye.
- Significant media opacities, including cataract, which may interfere with visual acuity assessment or fundus photography evaluation of the study eye (i.e. foveal atrophy, fibrosis, etc.).
- Significant likelihood of requiring cataract surgery in the study eye in the next 12 months.
- Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
- Non-pharmacologic treatment (intraocular surgery or thermal laser) within three (3) months of trial entry.
- Prior thermal laser in the macular region, regardless of indication.
- Ocular or periocular infection in the past twelve (12) weeks.
- History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, or corneal transplant.
- Previous therapeutic radiation in the region of the study eye.
General Exclusion Criteria:
- Any of the following underlying conditions or diseases including:
• A definitive diagnosis of diabetes mellitus or diabetic retinopathy (regardless of HbA1c level)
• HbA1c value of =6.5% (If the HbA1c value is = 6.5% and = 6.9%, and the patient has no signs or symptoms of diabetes mellitus, has a normal creatinine, has no diabetic retinopathy and no glycosuria, then the patient may have an oral glucose tolerance test (OGTT) at the discretion of the investigator. If the 2-hour glucose value on OGTT is <200 mg/dL (<11.1mmol/L), then the patient may be enrolled.)
• History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect in
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method