A Phase 4 interventional study of Ranibizumab and Ranibizumab in Macular Degeneration and Visual Acuity, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Status unknown at 1 site in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2008-12-23.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 4, Interventional, and Treatment
The purpose of the investigators study is to look at the visual outcomes of Ranibizumab injections in combination with photodynamic therapy for the treatment of neovascular age-related macular degeneration.
The main cause of severe vision loss in patients with age-related macular degeneration (AMD) is the development of choroidal neovascularization (CNV). This debilitating form of AMD affects the macula lutea, the central part of the retina, which is responsible for high resolution visual acuity. Characteristic findings in neovascular AMD include the development of new, abnormal blood vessels in the choroid layer beneath the macula otherwise known as CNV.
Current treatment options for this condition have included include laser therapy, photodynamic therapy (PDT), and intraocular injections (different types of anti-vascular endothelial growth factors) alone or in combination. While current treatments were demonstrated to slow the progression of vision loss, neither therapy was shown to significantly improve visual acuity.
Given their different modes of action, it is believed that combination therapy of Ranibizumab with PDT may lead to better visual outcomes and may result in an improved effect in treating AMD and therefore may help decrease the need for monthly Ranibizumab injections. After the first injection, regardless of which group the patient has been assigned to, they will receive Ranibizumab injections at 4 week intervals if clinically indicated. The purpose of the this study is to evaluate the visual outcomes of intraocular Ranibizumab injections in combination with photodynamic therapy with verteporfin for the treatment of neovascular AMD.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 180 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
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Exclusion Criteria:
Participants in this group will receive an intraocular Ranibizumab injection one week prior to the first PDT with verteporfin.
Drug: Ranibizumab
Participants in this group will receive an intraocular Ranibizumab injection one week post the first PDT with verteporfin.
Drug: Ranibizumab
Participants in this group will receive an intraocular Ranibizumab injection with no accompanying PDT with verteporfin.
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab one week prior to PDT with verteporfin
Also known as: Lucentis the brand name of Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab one week after PDT with verteporfin
Also known as: Lucentis the brand name of Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab with no accompanying PDT with verteporfin
Also known as: Lucentis the brand name of Ranibizumab
Mean change from baseline at 6 months in the best corrected visual acuity (VA) score using an early treatment diabetic retinopathy study eye chart at a starting distance of 4 meters.
Time frame: Monthly for a total of 12 months
To determine the following: 1:Proportion of subjects who loose fewer than 15 letters from baseline visual acuity at 6 months 2: Proportion of subjects with VA of 20/200 or worse 3: Proportion of subjects with VA of 20/40 or better
Time frame: One year
This study is status unknown, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre