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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02372916
Other study ID # 14-8235
Secondary ID
Status Recruiting
Phase N/A
First received February 20, 2015
Last updated February 25, 2015
Start date November 2014

Study information

Verified date February 2015
Source University Health Network, Toronto
Contact Crystal Cheung, MD
Phone 416-603-5376
Email cheuncsy@gmail.com
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective


Intervention

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

Locations

Country Name City State
Canada Toronto Western Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
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