Geographic Atrophy and Intravitreal Ranibizumab Injections

NCT ID: NCT02372916

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30

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.

Conditions

Age-related Macular Degeneration; Geographic Atrophy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Dry AMD

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

No interventions assigned to this group

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

Ranibizumab

Intervention Type: 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

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

Ranibizumab

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Crystal Cheung, MD

Role: CONTACT

cheuncsy@gmail.com

416-603-5376

Facility Contacts

Crystal Cheung

Role: primary

cheuncsy@gmail.com

416-603-5376

Other Identifiers

14-8235

Identifier Type: -

Identifier Source: org_study_id