Macular Degeneration, Visual Acuity
Conditions
Keywords
ranibizumab, verteporfin
Brief summary
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.
Detailed description
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.
Interventions
DRUGRanibizumab
Intraocular injection of 0.5mg of Ranibizumab one week prior to PDT with verteporfin
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosed with any subtype of primary subfoveal or juxtafoveal choroidal neovascularization * must be 50 years of age or older * have a lesion whose total size is no more than 5400micrometres in greatest linear dimension in the study eye * CNV that is more than 50% obscured by blood * have best corrected visual acuity of 20/50-20/320 (Snellen equivalent) * have been assessed with the use of early treatment diabetic retinopathy study charts
Exclusion criteria
* previous treatment (including verteporfin therapy) that could compromise an assessment of the study treatment * any permanent structural damage to the central fovea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Monthly for a total of 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | One year |
Countries
Canada
Contacts
Primary ContactJohn Galic, MD
Backup ContactKarin Oliver, MD
Outcome results
None listed