macular degeneration
Conditions
Interventions
Treatment with ranibizumab.
Sponsors
Novartis Pharma BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or female patients at least 50 years of age. • Visual impairment predominantly due to neovascular AMD. • Active, newly diagnosed, untreated, angiographically documented CNV lesion (see protocol page 22 for details) secondary to AMD. • CNV or sequelae of the CNV involving the center of the fovea. • The total area of fibrosis comprising less than 50% of the lesion area. • BCVA score at Screening and Baseline between 78 and 23 letters (see protocol page 22 for details).
Exclusion criteria
Exclusion criteria: • Pregnant or nursing (lactating) women. Women of child-bearing potential, not practicing adequate contraception. • Stroke or myocardial infarction less than 3 months prior to Screening. • Systolic BP >160 mm Hg or diastolic BP >100 mm Hg at Screening or Baseline. • Any active (peri)ocular infection or inflammation. • Uncontrolled glaucoma (intraocular pressure>=30 mm Hg on medication). • Neovascularization of the iris or neovascular glaucoma. • Exclusion criteria study eye and prior or current medications: see protocol page 24.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCVA change from Month 4 to Month 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time course of BCVA, treatment frequency/reason/compliance/duration, treatment-free intervals, OCT parameters. Patient-reported outcomes (VFQ-25). Adverse events. | — |
Countries
Netherlands
Outcome results
None listed