age-related neovascular macular degeneration MedDRA version: 14.0 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Lucentis
Product Name: Lucentis
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ranibizumab
CAS Number: 347396-82-1
Current Sponsor code: Lucentis
Concentration unit: mg/m
Sponsors
Klinikum Bremen-Mitte gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of either gender, aged 50 years and older with subfoveal CNV secondary to agerelated macular degeneration (AMD) and without previous AMD treatment will constitute the study population. If both eyes of one patient are eligible, the eye with the better visual acuity (VA) will be chosen for treatment according to this trial. All patients in compliance with inclusion criteria are offered enrollment in the study: Visual impairment described by a BCVA of 20/40 to 20/320 (Snellen equivalent, Early Treatment Diabetic Retinopathy Study (ETDRS) chart) due to an active primary or recurrent CNV associated with AMD involving the foveal center, presenting with either · a classical / predominantly classical lesion with largest diameter of SNVM smaller than greatest distance between major temporal vascular arcades or · a minimally classical lesion or an occult lesion with no classic choroidal neovascularization (determined by FA and fundus photography) 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
Exclusion criteria: · Known or suspected hypersensitivity to ranibizumab or bevacizumab · Participation in any clinical trial within the last 4 weeks · Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, bevacizumab ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.) · Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye · Previous subfoveal focal laser photocoagulation in the study eye · Previous laser photocoagulation (juxtafoveal or extrafoveal) in the study eye · History of vitreoretinal surgery in the study eye · History of submacular surgery or other surgical intervention for AMD in the study eye · Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either 50% or more of the total lesion area or 1 or more disc areas in size · Subfoveal fibrosis or atrophy in the study eye · CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia · Retinal pigment epithelial tear involving the macula in the study eye · Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either (a) require medical or surgical intervention during the 24-months study period to prevent or treat visual loss that might result from that condition, or (b) if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 24-months study period · Active intraocular, ocular, or periocular inflammation (any grade "trace" or above) in the study eye · Current vitreous hemorrhage in the study eye · History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye · History of idiopathic or autoimmune-associated uveitis in either eye · Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye · Aphakia or absence of the posterior capsule in the study eye · Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia · Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding day 0 · Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) of 30 mmHg or more despite treatment with antiglaucoma medications) · History of glaucoma filtering surgery in the study eye · History of corneal transplant in the study eye · Premenopausal women not using adequate contraception · 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 interpretation of the results of the study or render the subject at high risk for treatment complications · Current treatment for active systemic infection · History of allergy to fluorescein, not amenable to treatment with diphenhydramine · Inability to obtain fundus photographs or FA of sufficient quality to be analyzed and graded by the Independent Reading Center · Inability to comply with study or follow-up procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Mean change from baseline in BCVA at month 12 (interim analysis) and month 24;Secondary Objective: · Proportion of patients with a vision acuity loss of fewer than 15 letters at month 12 compared with baseline) · Proportion of patients with a loss of fewer than 15 letters at month 24 (compared with baseline) · Proportion of patients with a treatment-free interval of at least 3 months duration at any time point following month 2 · Number of doses of the study drugs · Drop out rates · Rate of non-responders · Retinal lesions · AEs · Quality of Life ;Primary end point(s): · Mean change from baseline in BCVA at month 12 (interim analysis) and month 24 | — |
Countries
Germany
Outcome results
None listed