NCT02372916

Geographic Atrophy and Intravitreal Ranibizumab Injections

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Age-related Macular Degeneration
• Geographic Atrophy

Interventions

Type	Name	Description
DRUG	Ranibizumab	The medication Ranibizumab is routine standard of care for patients with wet AMD, and this is not an aspect of the study that is considered novel intervention

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-11-01
• First posted: 2015-02-26
• Last updated: 2015-02-26

Locations

1 site across 1 country: Canada