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Geographic Atrophy and Intravitreal Ranibizumab Injections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372916
Recruitment Status : Unknown
Verified February 2015 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment
Age-related Macular Degeneration Geographic Atrophy Drug: Ranibizumab

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Progression of Geographic Atrophy and Intravitreal Injections of Ranibizumab Among Treated for Age-related Macular Degeneration
Study Start Date : November 2014
Estimated Primary Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Group/Cohort Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. Geographic atrophy area progression [ Time Frame: Every 6 month for total of 2 years ]
    To assess the association between rate of geographic atrophy (GA) progression in age-related macular degeneration (AMD) and repeated intravitreal ranibizumab injections


Secondary Outcome Measures :
  1. Geographic atrophy morphological characteristics [ Time Frame: Every 6 month for total of 2 years ]
    To determine the difference of GA morphological characteristics between AMD patients receiving intravitreal injections and those who are not

  2. Concordance of GA enlargement rate between the two eyes [ Time Frame: Every 6 month for total of 2 years ]
    To determine the concordance of GA enlargement rate between the two eyes for patients with bilateral GA



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with both dry and wet-AMD
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372916


Contacts
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Contact: Crystal Cheung, MD 416-603-5376 cheuncsy@gmail.com

Locations
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Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Crystal Cheung    416-603-5376    cheuncsy@gmail.com   
Principal Investigator: Wai-Ching Lam         
Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02372916    
Other Study ID Numbers: 14-8235
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents