Evaluation of Wet Age-Related Macular Degeneration (AMD) Genetic Profile Interactions With Ranibizumab Treatment Outcomes
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      Age Related Macular Degeneration (AMD) is the leading cause of blindness in North America.
      This condition causes a progressive loss of central vision, the part of your vision that
      allows you to read, drive and see images in sharp detail directly in front of you. The wet
      form of AMD is characterized by the growth and leakage of small blood vessels into the
      choroid layer of the eye, or the back of the eye. These leaking blood vessels disrupt the
      structure and function of the eye, causing loss of vision, particularly the sharp vision
      created by the macula area of the eye.

      Currently, the best treatment for wet AMD is a series of injections of an anti-vascular
      endothelial growth factor (anti-VEGF) drug, ranibizumab (Lucentis). The clinical response to
      treatment is varied. Approximately 70% of patients see a moderate vision gain (3-line gain on
      a visual acuity chart), but there are 30% who do not see a similar improvement in vision.
      There is no way to identify those patients who will respond with significant vision gain
      versus those who will not experience moderate vision gain. Recent research into AMD has
      demonstrated that genetic mutations are proving to be key risk factors for patients
      developing wet AMD, with up to 80% of wet AMD cases explained by inherited genetic
      variations. Scientists have theorized that there may be a genetic difference between those
      patients who see significant responses to treatment and those who do not. The investigators
      will be testing participant's genetic profile using the Macula Risk test and following their
      progress through the standard treatment for wet AMD over the course of this study. This study
      aims to demonstrate the association between known genetic variations and patient responses to
      treatment.
    

Detailed description: 
      Your ophthalmologist will determine your suitability for this study through a screening
      protocol. You will have measurements of your visual acuity and will undergo a series of
      imaging tests as described in the next paragraph to show presence of blood vessel growth in
      the back of your eye (the choroid). You cannot be included in this study if you have another
      significant eye disease that affects your vision, if you have blood vessel growth in the back
      of your eye (choroid) for reasons other than AMD, if you have medically uncontrolled
      glaucoma, if you have been treated for AMD in that past, if you have had intra-ocular surgery
      in the study eye in the past 3 months, if you have had any past retinal or vitreous surgery,
      or if you have physical or mental disabilities that would prevent accurate vision testing.

      At the beginning of the study, we will take a sample of cells from the inside of your cheek,
      using a small swab. The sample will be sent to a genetic laboratory for analysis and storage.
      This information will be kept masked for the duration of the study, meaning that you, the
      study ophthalmologist and the data analyzer will not know the results of the genetic test
      until the study is completed.

      You will be asked to come in for an initial assessment to determine your starting visual
      abilities and medical history. On your next appointment, you will receive your first
      treatment of intra-vitreal injections of Ranibizumab (Lucentis). You will be asked to come
      into the clinic every month for six (6) months total for treatment injections and testing. At
      each appointment, we will take 3-D images of your retina (the back of your eye) using an
      Optical Coherence Tomography (OCT) imaging device, test your eye pressure and determine if
      there are any signs of infection or inflammation from the injections. On months 1, 3, and 6
      we will also test your vision, your contrast sensitivity using a standard contrast
      sensitivity chart (The Pelli-Robson chart) and take images of the blood vessel growth using a
      coloured dye (fluorescein) to help us see your vessels. Before every treatment, anesthetic
      eye drops (proparacaine) will be applied to your eye so you will not feel the injections. You
      will be given antibiotic eye drops (Zymar®) that you will be asked to use 4 times a day for a
      few days after the injection to prevent infection.
    

Intervention name(s): Ranibizumab
Intervention type(s): Drug
Intervention description(s): Intra-vitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2. For those requiring additional injections, patients will receive monthly treatment up to a maximum of 6 months total.
Other intervention name(s): Lucentis
Intervention MeSH terms: Ranibizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Macular Degeneration; Age related macular degeneration; Macula Risk; Genetic test; Anti-inflammatory; Anti-vascular endothelial growth factor (Anti-VEGF); Lucentis; Ranibizumab; Vision loss