Recruiting

Ranibizumab

Sponsor:

University Health Network, Toronto

Code:

NCT02372916

Conditions

Age-related Macular Degeneration

Geographic Atrophy

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Ranibizumab

Study Details

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 ID

NCT02372916

Start date

Nov, 2014

Status verified date

Feb, 2015

Primary completion date

Nov, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

Dry AMD

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

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

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

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

Primary outcome measure

  • Geographic atrophy area progression [ Time Frame: Every 6 month for total of 2 years ]

Central Contacts and Locations

Central contacts

Crystal Cheung, MD

416-603-5376cheuncsy@gmail.com

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Crystal Cheung

416-603-5376cheuncsy@gmail.com

Principal Investigator:

Wai-Ching Lam

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 26, 2015

Last verified

Feb, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2015-02-26.