Clinical Trial: Geographic Atrophy and Intravitreal Ranibizumab Injections

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Progression of Geographic Atrophy and Intravitreal Injections of Ranibizumab Among Treated for Age-related Macular Degeneration

Brief Summary:

Given the aging population who will be affected by wet AMD and lack of effective GA treatment, it is crucial to assess the safety profile of repeated ranibizumab injections in AMD patients with GA, particularly the possible risk of GA development and enlargement. This potential adverse effect has significant implication in the discussions with patients regarding the risks and benefits of AMD treatment and injection frequency. While monthly injections provide slight improvement of visual acuity at 2 years (Martin et al., 2012), the risk of GA enlargement may offset this benefit in visual acuity.

Previous studies assessed the association between intravitreal ranibizumab injections and de novo GA development in injection-naïve eyes (Martin et al, 2012, Querques et al., 2012., Grunwald et al., 2014), rather than GA enlargement in patients with preexisting GA. To the best of the investigators knowledge, there has been no prospective study assessing the association between intravitreal ranibizumab injections and rate of GA progression in patients with pre-existing GA. There is also no prospective study comparing the morphological features of GA between patients who are receiving intravitreal injections and those who are not, nor the concordance of GA enlargement rate between the 2 eyes among patients receiving and not receiving treatment.


Detailed Summary:
Sponsor: University Health Network, Toronto

Current Primary Outcome: Geographic atrophy area progression [ Time Frame: Every 6 month for total of 2 years ]

To assess the association between rate of geographic atrophy (GA) progression in age-related macular degeneration (AMD) and repeated intravitreal ranibizumab injections


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Geographic atrophy morphological characteristics [ Time Frame: Every 6 month for total of 2 years ]
    To determine the difference of GA morphological characteristics between AMD patients receiving intravitreal injections and those who are not
  • Concordance of GA enlargement rate between the two eyes [ Time Frame: Every 6 month for total of 2 years ]
    To determine the concordance of GA enlargement rate between the two eyes for patients with bilateral GA


Original Secondary Outcome: Same as current

Information By: University Health Network, Toronto

Dates:
Date Received: February 20, 2015
Date Started: November 2014
Date Completion:
Last Updated: February 25, 2015
Last Verified: February 2015