Clinical Trial: Ranibizumab for the Treatment of Choroidal Neovascularisation (CNV) Secondary to Pathological Myopia (PM): an Individualized Regimen

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II, Open-label, Multicentre, 12 Month Study to Evaluate the Efficacy and Safety of Ranibizumab (0.5mg) in Patients With Choroidal Neovascularisation Secondary to Patholog

Brief Summary:

This study is designed to provide efficacy and safety data in patients with choroidal neovascularisation (CNV) secondary to myopia using an individualized as-needed (PRN) dosing schedule. Eligible patients who have provided written agreement to take part in the study will receive an intravitreal (into the study eye) injection of ranibizumab 0.5mg. Following eye examinations and tests at monthly clinic visits, the study doctor will repeat the injections on a monthly basis as required for an additional 11 months, in accordance with specified retreatment criteria.

Patients will be in the study for approximately 12 months and will visit the hospital clinic 14 times over that period. The main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography and fluorescein angiography (FA), measurement of intraocular pressure, blood pressure and pulse measurements and completion of health-related questionnaires'.


Detailed Summary:
Sponsor: Novartis

Current Primary Outcome: The difference from baseline in mean Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mean change in BCVA from baseline [ Time Frame: 6 months ]
  • Mean change in Central retinal Thickness (CRT) from baseline [ Time Frame: 6 and 12 months ]
  • Percentage of patients gaining ≥ 15 letters [ Time Frame: 12 months ]
  • Change in lesion size and morphology from baseline [ Time Frame: 6 and 12 months ]
  • Time to the first retreatment and the total number of treatments [ Time Frame: 12 Months ]


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: December 21, 2009
Date Started: January 2010
Date Completion:
Last Updated: April 15, 2016
Last Verified: April 2016