Health Condition 1: null- Age-related Macular Degeneration Choroidal Neovascularization
Conditions
Interventions
Intervention1: Active Comparator: Group 1 (monthly regimen)
Drug: Ranibizumab 0.5mg: 0.5 mg ranibizumab (marketed Lucentis®).
Lucentis 10mg/ml solution for injection given intravenously as monthly i
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: •Male or female patients, >=50 years of age with signed informed consent before study procedures •Visual impairment predominantly due to nAMD. •Active CNV secondary to AMD confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and/or color fundus photography •Presence of intra- or subretinal fluid/hemorrhage seen by SD-OCT •BCVA score must be = 23 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximate Snellen equivalent of 20/32 and 20/320)
Exclusion criteria
Exclusion criteria: •Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk. •Stroke or myocardial infarction within 3 months prior to Screening. •Any active periocular or ocular infection or inflammation in both eyes. •Ocular disorders in the study eye at the time of enrollment that may confound interpretation of study results and compromise visual acuity. •Presence of amblyopia or amaurosis in the fellow eye. •History of treatment with any anti-angiogenic drugs (including any anti- vascular endothelial growth factor (anti-VEGF) agents) e.g., bevacizumab [Avastin®], aflibercept [Eylea®]) or vPDT in the study eye. •History of intravitreal treatment with corticosteroids within 6 months and history of intra-ocular surgery within 3 months in the study eye prior to the Screening. •Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCVA change; by measuring BCVA score at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chartsTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in central retinal thickness of the study eye over time.To evaluate the change in central subfield retinal thickness (CSFT) collected by SD-OCT, as evaluated by the Central Reading Center (CRC) from baseline, over time up to Month 12Timepoint: 12 months;Change in BCVA score from baseline to month 12Timepoint: baseline to month 12;Percentage of patients with Best Corrected Visual Acuity (BCVA) improvements â?¥1, â?¥5, â?¥10, â?¥15, and â?¥30 letters by visit.Evaluate the occurrence of BCVA improvements of â?¥1, â?¥5, â?¥10, â?¥15, and â?¥30 letters from baseline, over time up to Month 12. Measurements taken at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chartsTimepoint: 12 Months;Period (time) between injections.To assess treatment frequency and average dosing intervalTimepoint: 12 months | — |
Countries
Belgium, Croatia, Denmark, Egypt, Germany, Hungary, India, Italy, Portugal, Slovakia, Slovenia, Spain, Switzerland, Turkey
Contacts
Public ContactMurugananthan K
Novartis Healthcare Pvt. Ltd
Outcome results
None listed