Visual impairment due to neovascular AMD MedDRA version: 18.1 Level: LLT Classification code 10060837 Term: Choroidal neovascularization System Organ Class: 100000004853
Conditions
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for patient 1. Male or female patients, = 18 years of age (= 50 years of age; applicable in France). 2. Written informed consent must be obtained before any study-related assessment is performed. Inclusion criteria for study eye 3. Visual impairment predominantly due to neovascular AMD. 4. Active, newly diagnosed, angiographically documented CNV lesion (i.e.leakage on fluorescein angiography plus intraretinal, subretinal or sub RPE fluid on OCT) secondary to AMD in an eye previously untreated with verteporfin PDT, external-beam radiation, subfoveal or extrafoveal focal laser photocoagulation, transpupillary thermotherapy, submacular surgery, or any other surgical intervention for wAMD, any anti-VEGF compound or any investigational treatment, intravitreal or subtenon corticosteroid injection (within 90 days prior to screening) or device implantation; in line with Summary of product characteristics of ranibizumab (Lucentis®) and aflibercept (Eylea®). If both eyes are eligible for the study, the eye with the lower visual acuity will be defined as the study eye. This decision and confirmation needs to be documented in the electronic case report form (eCRF) and in the source documents of the patient. The study eye is the one treated with the study treatment, assessed according to protocol requirements and as outlined in the Assessment Schedule (Table 7-1) and data collected on the study eye are used for the evaluation of efficacy objectives of the study. 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 71 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 635
Exclusion criteria
Exclusion criteria: Exclusion criteria for patient 1. Inability to comply with study or follow-up procedures. 2. Women o who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)) o who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index 160 mm Hg or diastolic value of >100 mm Hg at screening or baseline. 6. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, or to fluoresceine. Exclusion criteria for ocular medical history and conditions For either eye 7. Any active periocular or ocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at the time of screening or baseline as per summary of product characteristics for both drugs. 8. Uncontrolled glaucoma (intraocular pressure [IOP] =30 mm Hg on medication or according to investigator’s judgment) at the time of screening or baseline. 9. Neovascularization of the iris or neovascular glaucoma at the time of screening or baseline. 10. Inability to obtain OCT images of sufficient quality to be analyzed. For study eye 11. Cataract (if causing significant visual impairment), planned cataract surgery during the study period, aphakia, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wAMD (e.g., ocular histoplasmosis, pathologic myopia) at the time of screening and baseline. 12. Irreversible structural damage within 0.5 disc diameter of the center of the macula (e.g., vitreomacular traction, epiretinal membrane, scar, laser burn, macular hole) at the time of screening and baseline that in the investigator’s opinion could preclude visual function improvement with treatment. 13. Atrophy or fibrosis involving the center of the fovea. Exclusion criteria for prior or current systemic medication 14. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 15. Use of any systemic anti-VEGF drugs (e.g., bevacizumab [Avastin®]). 16. Use of systemic or intravitreal corticosteroids for at least 30 consecutive days within 3 months prior to screening. 17. Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine (Plaquenil®), tamoxifen, phenothiazines and ethambutol. Exclusion criteria for prior or current ocular treatment For fellow eye 18. Treatment with any anti-angiogenic drugs (including any anti-VEGF agents) with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the treatment effect of ranibizumab PRN (BCVA loss and/or SD-OCT disease activity guided retreatment) versus aflibercept bimonthly regimen on CSRT stability as measured by mean CSRT fluctuations between study Month 3 and 6.;Secondary Objective: The secondary objective of this study is as follows: • To demonstrate correlation of functional outcome (BCVA) at month 12 with retinal stress, defined as significant fluctuations in central retinal thickness, parameters as measured by SD-OCT up to moth 6. ;Primary end point(s): CSRT stability as measured by mean CSRT fluctuations between study Month 3 and 6.;Timepoint(s) of evaluation of this end point: Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Correlation of functional outcome (BCVA) at month 12 with retinal stress, defined as significant fluctuations in central retinal thickness, parameters as measured by SD-OCT up to moth 6. ;Timepoint(s) of evaluation of this end point: Month 12 | — |
Countries
Austria, Belgium, Denmark, France, Germany, Greece, Netherlands, Norway, Portugal, Sweden, Switzerland
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed