Clinical trial NCT02372916: Geographic Atrophy and Intravitreal Ranibizumab Injections
Official title: Progression of Geographic Atrophy and Intravitreal Injections of Ranibizumab Among Treated for Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-related Macular Degeneration
Geographic Atrophy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with both dry and wet-AMD

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.


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

Primary outcomes:
measure: Geographic atrophy area progression
timeFrame: Every 6 month for total of 2 years
Secondary outcomes:
measure: Geographic atrophy morphological characteristics
timeFrame: Every 6 month for total of 2 years
measure: Concordance of GA enlargement rate between the two eyes
timeFrame: Every 6 month for total of 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References: