Geographic Atrophy and Intravitreal Ranibizumab Injections

• Conditions: Age-related Macular Degeneration; Geographic Atrophy
• Interventions: Drug: Ranibizumab

• Registration Number: NCT02372916
• Lead Sponsor: University Health Network, Toronto

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 Description

Not available

Study Timeline

• Study Start: 2014-11
• Status Verified: 2015-02
• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-02-25
• Last Update Submitted: 2015-02-25
• Study First Posted: 2015-02-26
• Last Update Posted: 2015-02-26
• Primary Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Wet AMD with history of intravitreal injections	Ranibizumab	Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and have received previous intravitreal injections
Wet AMD and treatment-naive	Ranibizumab	Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and are treatment-naïve patients

Primary Outcome Measures

Name	Time	Method
Geographic atrophy area progression	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 Outcome Measures

Name	Time	Method
Geographic atrophy morphological characteristics	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	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

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada