Geographic Atrophy and Intravitreal Ranibizumab Injections

Age-related Macular Degeneration Clinical Trial

Official title:

Progression of Geographic Atrophy and Intravitreal Injections of Ranibizumab Among Treated for Age-related Macular Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02372916
• Other study ID #: 14-8235
• 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. 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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Atrophy
• Geographic Atrophy
• Macular Degeneration

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