Geographic Atrophy and Intravitreal Ranibizumab Injections

University Health Network, Toronto

Status: Unknown

Conditions: Geographic Atrophy; Age-related Macular Degeneration

Treatments: Drug: Ranibizumab

Study type: Observational

Funder types: Other

Identifiers

NCT02372916

14-8235

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

Dry AMD

Description:

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

Wet AMD and treatment-naive

Description:

Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and are treatment-naïve patients

Treatment:

Drug: Ranibizumab

Wet AMD with history of intravitreal injections

Description:

Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and have received previous intravitreal injections

Treatment:

Drug: Ranibizumab