Geographic Atrophy and Intravitreal Ranibizumab Injections

Overview

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.

Full Title of Study: “Progression of Geographic Atrophy and Intravitreal Injections of Ranibizumab Among Treated for Age-related Macular Degeneration”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2016

Interventions

  • 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

Arms, Groups and Cohorts

  • Dry AMD
    • Patients with pre-existing GA secondary to AMD NOT requiring intravitreal injections (i.e. Dry AMD)
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Age > 50 years old
  • Patients with pre-existing GA secondary to AMD NOT requiring intravitreal injections (i.e. Dry AMD)
  • Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and are treatment-naïve patients
  • Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and have received previous intravitreal injections.
  • Able to maintain steady fixation in foveal and parafoveal area for fundus imaging Geographic atrophy (GA), both foveal-sparing and foveal GA. Foveal-sparing GA is defined as no GA within 250μm of the centre (Sunness et al. 1999)
  • Area of GA can be imaged in its entirety and is not contiguous with areas of peripapillary atrophy
  • Adequate media clarity for quality fundus images

Exclusion Criteria

  • Inability to undergo study procedures (e.g. contraindications to intravitreal injections) or attend follow-up visits CNV attributable to other causes than AMD
  • Active intraocular inflammation
  • Any other retinopathy, including diabetic retinopathy, retinal venous occlusion, epiretinal membrane

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Crystal Cheung, MD, 416-603-5376, cheuncsy@gmail.com

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