Role of multimodal imaging in the evaluation of anatomic alterations in neovascular Age-Related Macular Degeneration (AMD) subjects: 18 month Phase 2a open label study of Fovista® (anti-PDGF therapy) administered in combination with anti-VEGF therapy

OPHTHOTECH CORPORATIO0 sites32 target enrollmentAugust 5, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Subfoveal choroidal neovascularization secondary to Age-Related Macular Degeneration (AMD)
Sponsor: OPHTHOTECH CORPORATIO
Enrollment: 32
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

August 5, 2015

End Date

January 6, 2017

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

OPHTHOTECH CORPORATIO

•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:

•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.).