A trial to establish the safety and efficacy of administration of Fovista® (Anti-PDGF therapy) in combination with Avastin® compared to Avastin® only in subjects with subfoveal neovascular age-related macular degeneration.
- Conditions
- Subfoveal neovascular age-related macular degeneration (AMD)MedDRA version: 18.1Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 18.1Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2015-000518-23-NL
- Lead Sponsor
- OPHTHOTECH CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 340
* Ophthalmic Inclusion Criteria
The following inclusion criteria apply to the study eye:
- Presence of subfoveal active CNV. Active CNV” is defined as the presence of fluorescein leakage consistent with choroidal neovascularization.
- Presence of subretinal or intraretinal fluid in the anatomic fovea by OCT.
- Best corrected visual acuity in the study eye between 20/63 and 20/200, inclusive.
- Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be = 9 disc areas (DA), of which at least 50% must be active CNV.
- Clear ocular media and adequate pupillary dilatation to allow collection of fundus photographs and fluorescein angiograms of a sufficient quality to be analyzed.
- Intraocular pressure (IOP) of 21 mmHg or less.
*General Inclusion Criteria
- Subjects of either gender aged 50 years or over.
- Performance Status under or equal to 2 according to Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) scale (Appendix 17.4).
- 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 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170
Subjects will not be eligible for the trial if any of the following criteria are present in the study eye or systemically:
* Ophthalmic Exclusion Criteria
- Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals.
- Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids).
- Subjects with subfoveal scar or subfoveal atrophy (by OCT and/or by fundus Photography)
- More than 50% of the total lesion size consisting of subretinal hemorrhage.
- Presence of retinal angiomatous proliferation (RAP).
- 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 = 500 µm.
- Presence of pure PED.
- Presence of pigment epithelial tears or rips.
- Presence of intraocular inflammation (= trace cell or flare), 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 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 photodynamic therapy within three (3) months of trial entry.
- 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.
* 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 interpretat
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objectives of this study are to evaluate the safety and efficacy of Fovista® (E10030 or pegpleranib) intravitreous administration when administered in combination with Avastin® compared to Avastin® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).;Secondary Objective: N/A;Primary end point(s): The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the Month 18 visit.;Timepoint(s) of evaluation of this end point: Following Month 18 visit.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety endpoints include adverse events, vital signs, ophthalmic variables [ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)], ECG, and laboratory variables.;Timepoint(s) of evaluation of this end point: Following Month 18 visit.