A phase 2, randomized, double-masked, controlled trial to establish the safety and efficacy of intravitreous injections of E10030 (anti-PDGF pegylated aptamer) given in combination with Lucentis in subjects with neovascular age-related macular degeneration - REGRESS

• Conditions: neovascular age-related macular degeneration; MedDRA version: 9.1Level: LLTClassification code 10064930; MedDRA version: 9.1Level: LLTClassification code 10015902

• Registration Number: EUCTR2010-018741-65-IT
• Lead Sponsor: OPHTHOTECH CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-13
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 444

Inclusion Criteria

The following inclusion criteria apply to the study eye:
•Subfoveal choroidal neovascularization (CNV) due to AMD with some classic component (i.e., predominantly classic or minimally classic) as documented by fluorescein angiogram.
•Best corrected visual acuity in the study eye between 20/63 and 20/200, inclusive. The VA must be re-confirmed at Day 0 prior to randomization.
•Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be = 5 disc areas (DA), of which at least 50% must be active CNV. Active CNV is defined as the neovascular component of the lesion as defined by the fluorescein angiogram.
•Presence on OCT of subretinal fluid and/or cystoid macular edema and an abnormal central retinal thickness defined as:
•Stratus central subfield > 250 microns
•Topcon central subfield > 290 microns
•Cirrus central subfield > 300 microns
•Heidelberg central subfield > 210 microns
•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.
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

•Any prior treatment for AMD in the study eye prior to the baseline visit, except oral supplements of vitamins and minerals.
•Any prior intravitreal treatment in the study eye prior to the baseline visit, regardless of indication (including intravitreal corticosteroids).
•More than 25% of the total lesion size made up of scarring or atrophy. Subjects with subfoveal scar or subfoveal atrophy are excluded.
•More than 50% of the total lesion size consisting of subretinal hemorrhage.
•Presence of retinal angiomatous proliferation (RAP).
•Presence of significant pigment epithelial detachments (PEDs) such as large PEDs that constitute greater than 50% of the total lesion.
•Presence of pigment epithelial tears or rips.
•Presence of intraocular inflammation (= trace cell or flare), epiretinal membrane, macular hole 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 might interfere with visual acuity, assessment of toxicity, or fundus photography in the study eye. Subjects should not be entered if there is likelihood that they will require 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), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
•Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
•Any 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, corneal transplant.
•Previous therapeutic radiation in the region of the study eye.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified