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 disorders MedDRA version: 18.0 Level: LLT Classification code 10067791 Term: Wet macular degeneration
Conditions
Interventions
Product Name: Fovista
Product Code: E10030
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pegpleranib sodium
CAS Numbe
Sponsors
OPHTHOTECH CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion 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.). - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and biomarker responses of various regimens of Fovista® when administered in combination with anti-VEGF agents, in treatment naïve and treatment experienced neovascular AMD subjects.;Secondary Objective: N/A; Primary end point(s): Biomarker Imaging Endpoints: Modalities: (Fluorescein Angiography (FA), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT), Optical Coherence Tomography Angiography (OCTA) - CNV and/or CNV complex analysis with respect to area and/or volume and/or flow Safety Endpoints: - Severe Visual Acuity Loss (Proportion of subjects with >15 letter loss at Months 12 and 18) - Ophthalmic Adverse Events (AEs) - Systemic Adverse Events (AEs) - Laboratory data (blood: hematology, renal function, hepatic function, and electrolytes) ;Timepoint(s) of evaluation of this end point: Following Month 0-8, 10-14 and 16-18 visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): n/a;Timepoint(s) of evaluation of this end point: n/a | — |
Countries
France, Italy
Contacts
Public ContactLoni da Silva
OPHTHOTECH CORPORATION
Outcome results
None listed