CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 531 enrolled
Drug / intervention
Ranibizumabdrug
Likely dose
Ranibizumab 0.3 mg and/or 0.5 mgAI-extracted
Key inclusion· 5
  • ✓Male or female patients aged >50 years
  • ✓Diagnosis of active primary or recurrent CNV secondary to AMD (including predominantly classic, minimally classic, or occult lesions without classic component)
  • ✓Total area of CNV must encompass ≥50% of total lesion area
  • ✓Total lesion area ≤12 disc areas
Key exclusion· 3
  • ✕BCVA <34 letters (legally blind) in both eyes
  • ✕Laser photocoagulation, intravitreal steroids, verteporfin photodynamic therapy, or pegaptanib sodium in study eye within 30 days before Day 1
  • ✕Prior participation in clinical trial involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00331864
NCT00331864Phase 3Completed
CompareCT.gov

A Phase IIIb, Open-label, Multi-center 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of Ranibizumab (0.3 mg and/or 0.5 mg) in Patients With Subfoveal Choroidal Neovasculariza-tion Secondary to Age-related Macular Degeneration

Novartis·interventional·Posted May 31, 2006·Updated Feb 18, 2011

In Brief

A Phase 3 clinical trial evaluating Ranibizumab for Age Related Macular Degeneration and Choroidal Neovascularization. Completed, enrolled 531 participants across 1 site.

Detailed Summary

Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A. This study will assess the safety and efficacy of ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAge Related Macular Degeneration, Choroidal Neovascularization
CountriesSwitzerland
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 31, 2006
Enrollment StartApr 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.1 years ago

Interventions

Ranibizumabdrug