Geographic Atrophy and Intravitreal Ranibizumab Injections

Sponsor
University Health Network, Toronto
Study ID
NCT02372916
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    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

Study Details

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.

Key Dates

First listed
Feb 26, 2015
Start date
Nov 30, 2014
Status verified
Feb 2015
Primary completion
Nov 30, 2016

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: Dry AMD
    Patients with pre-existing GA secondary to AMD NOT requiring intravitreal injections (i.e. Dry AMD)
  • Arm: Wet AMD and treatment-naive
    Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and are treatment-naïve patients
  • Arm: Wet AMD with history of intravitreal injections
    Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and have received previous intravitreal injections

Primary Outcome Measure

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

Central Contacts

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