Geographic Atrophy and Intravitreal Ranibizumab Injections

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

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.

Study Overview

• Status: Unknown
• Conditions: Age-related Macular Degeneration; Geographic Atrophy
• Intervention / Treatment: Drug: Ranibizumab

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Toronto Western Hospital
      • Contact: Crystal Cheung; Phone Number: 416-603-5376; Email: cheuncsy@gmail.com
      • Principal Investigator: Wai-Ching Lam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with both dry and wet-AMD

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geographic atrophy area progression	To assess the association between rate of geographic atrophy (GA) progression in age-related macular degeneration (AMD) and repeated intravitreal ranibizumab injections	Every 6 month for total of 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: February 25, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 25, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Pathological Conditions, Anatomical; Macular Degeneration; Geographic Atrophy; Atrophy; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: 14-8235