Clinical Trial: An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.

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

Official Title: An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.

Brief Summary: The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Rate and severity of serious and non-serious, ocular and non-ocular adverse events [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Average change of BCVA for patients with CNV and ME [ Time Frame: 3 months ]
  BCVA will be tested using the ETDRS, the Snellen or Monoyer scales. VA measurements will be preferentially taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score will be calculated using the BCVA worksheet which will be kept in the source data and the score will be recorded in the eCRF. ETDRS, Snellen and Monoyer VA measurements will be transformed in logMAR to be analyzed.
• Average change of neovascularization extension for patients with neovascular glaucoma [ Time Frame: 3 months ]
  Change of the extent of iris neovascularization using "Teich and Walsh grading system" using iris photography
• Proportion of patient with Vitreous Cavity Hemorrhage occurrence for patient with proliferative retinopathy [ Time Frame: 3 months ]
  Occurrence of postoperative vitreous cavity hemorrhage

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: July 20, 2013
Date Started: September 2013
Date Completion:
Last Updated: March 14, 2017
Last Verified: March 2017