Subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD) MedDRA version: 14.1 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: E10030
Product Code: E10030
Pharmaceutical Form: Solution for injection
Current Sponsor code: E10030
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
OPHTHOTECH CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet the following criteria to be eligible to participate in this study. 8.2.1 Ophthalmic Inclusion Criteria The following inclusion criteria apply to the study eye: 8.2.1.1 Subfoveal choroidal neovascularization (CNV) due to AMD with some classic component (i.e., predominantly classic or minimally classic) as documented by fluorescein angiogram. 8.2.1.2 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. 8.2.1.3 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. 8.2.1.4 Presence on OCT of subretinal, intraretinal or sub-RPE fluid and/or subretinal thickening consistent with active CNV. 8.2.1.5 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. 8.2.1.6 Intraocular pressure (IOP) of 21 mmHg or less. 8.2.2 General Inclusion Criteria 8.2.2.1 Subjects of either gender, aged ? 50 years. 8.2.2.2 Performance Status ? 2 according to Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) scale (Appendix 17.4) 8.2.2.3 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. 8.2.2.4 Adequate hematological function: hemoglobin ? 10g/dL; platelet count ? 130 x 109/L; WBC ? 3.8 x 109/L. Subjects with results outside these ranges may be enrolled in consultation with Ophthotech. 8.2.2.5 Adequate renal function: serum creatinine ? 2.5 mg/dl (= 221µmol/L) and BUN within 2 x the upper limit of normal (ULN). Subjects with results outside these ranges may be enrolled in consultation with Ophthotech. 8.2.2.6 Adequate liver function: serum bilirubin ? 1.5 mg/dl (= 25.6 µmol/L), GGT, SGOT/ALT, SGPT/AST, and alkaline phosphatase within 2 x ULN. Subjects with results outside these ranges may be enrolled in consultation with Ophthotech. 8.2.2.7 Provide written informed consent. 8.2.2.8 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: 0 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
Exclusion criteria: Subjects will not be eligible for the trial if any of the following criteria are present in the study eye or systemically: 8.3.1 Ophthalmic Exclusion Criteria 8.3.1.1 Any prior treatment for AMD in the study eye prior to the baseline visit, except oral supplements of vitamins and minerals. 8.3.1.2 Any prior intravitreal treatment in the study eye prior to the baseline visit, regardless of indication (including intravitreal corticosteroids). 8.3.1.3 More than 25% of the total lesion size made up of scarring or atrophy. Subjects with subfoveal scar or subfoveal atrophy are excluded. 8.3.1.4 More than 50% of the total lesion size consisting of subretinal hemorrhage. 8.3.1.5 Presence of retinal angiomatous proliferation (RAP). 8.3.1.6 Presence of significant serous pigment epithelial detachments (PEDs), such as large PEDs that constitute greater than 50% of the total lesion. 8.3.1.7 Presence of pigment epithelial tears or rips. 8.3.1.8 Presence of intraocular inflammation (= trace cell or flare), significant epiretinal membrane or vitreomacular traction, macular hole or vitreous hemorrhage. 8.3.1.9 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. 8.3.1.10 History of idiopathic or autoimmune-associated uveitis in either eye. 8.3.1.11 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. 8.3.1.12 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. 8.3.1.13 Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication. 8.3.1.14 Any ocular or periocular infection in the past twelve (12) weeks. 8.3.1.15 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. 8.3.1.16 Previous therapeutic radiation in the region of the study eye. 8.3.2 General Exclusion Criteria 8.3.2.1 Any of the following underlying diseases including: • Diabetes mellitus, also defined as an HbA1c level = (greater than or equal to) 6.5%. • History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 17.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization within 6 months, or ventricular tachyarrythmias requiring ongoing treatment. • Clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function. • Stroke (within 12 months of trial entry). • Any major surgical procedure within one month of trial entry. 8.3.2.2 Any treatment with an investigational agent in the 60 days prior to randomization for any condition. 8.3.2.3 Known serious allergies to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to evaluate the safety and efficacy profile of E10030 intravitreous injection when administered in combination with Lucentis® 0.5 mg/eye versus monotherapy Lucentis® 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD);Secondary Objective: Not applicable;Primary end point(s): The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit.;Timepoint(s) of evaluation of this end point: Week 24 visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints of the trial, in order of importance, include: •The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit. •The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 12 visit. •The mean change in area of choroidal neovascularization from baseline at Week 24 (by fluorescein angiogram). •The mean change in visual acuity from baseline at Week 12. Principal supportive endpoints include: •The mean change in area of choroidal neovascularization from baseline at Week 12 (by fluorescein angiogram). •The mean change in total lesion size from baseline at Week 12 and 24. •The mean change in central subfield retinal thickness from baseline at Week 12 and 24 (by OCT). •The proportion of patients with RPE elevation (by OCT) at the baseline and Week 12 and 24 visits. •The proportion of patients losing = 0 letters on the ETDRS visual acuity chart from baseline at the Week 12 and 24 visits. •The proportion of patients gaining = 5 letters on the ETDRS visual acuity chart from baseline at the Week 12 and 24 visits. •The proportion of patients gaining = 10 letters on the ETDRS visual acuity chart from baseline at the Week 12 and 24 visits. •The proportion of patients gaining = 20 letters on the ETDRS visual acuity chart from baseline at the Week 12 and 24 visits. •The proportion of patients gaining = 25 letters on the ETDRS visual acuity chart from baseline at the Week 12 and 24 visits. •The proportion of patients gaining = 30 letters on the ETDRS visual acuity chart from baseline at the Week 12 and 24 visits. •The proportion of patients who are 20/40 or better at the Week 12 and Week 24 visits.;Timepoint(s) of evaluation of this end point: Week 12 and week 24 visits. Please see E.5.2 for details. | — |
Countries
Austria, Belgium, Colombia, France, Germany, Hungary, Israel, Italy, Latvia, Spain
Outcome results
None listed