OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab
Condition: Wet Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      In the Western World, Age Related Macular Degeneration (ARMD) is a leading cause of
      blindness. This disease was once thought to be a natural part of aging, but recent research
      has introduced effective treatments. ARMD is related to the body initiating an immune
      response in the eye, as if responding to an infection. Vision is impacted as ocular tissue
      becomes inflamed and new blood vessels form at the back of the eye, a process called
      angiogenesis. In the more severe wet form of ARMD, blood and fluid leak out of the vessels
      and impair the eye's structure and function. Many studies have shown that ranibizumab, a drug
      that stops the formation of new blood vessels (an anti-angiogenic agent) can delay damage to
      the eye and often restore vision. The investigators believe the best drug therapy will also
      stop the inflammation. OZURDEX, a steroid drug, has shown the potential to effectively reduce
      inflammation in this application. The investigators aim to investigate if patients receiving
      a combination treatment of ranibizumab and OZURDEX improve their visual abilities more than
      those receiving just ranibizumab treatment alone. Secondarily, the investigators will also
      investigate how often patients receiving each drug therapy regime require re-treatment and
      how often they experience further vision loss.
    

Detailed description: 
      Age Related Macular Degeneration (ARMD or AMD) is the leading cause of blindness in North
      America. There are two types of ARMD: dry and wet. Both forms of ARMD cause 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 is typically more severe and 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.

      Upon being accepted to the study, participants will be randomly divided into two groups. One
      group will receive both ranibizumab and OZURDEX injections and the other group will receive
      ranibizumab injections and a placebo treatment. To participants in this group, there will be
      the appearance of a second injection but no actual injection will take place. An individual
      not connected to the study will assign participants to a group based on a computer-generated
      system, giving participants at 50% chance of being placed in either group. During the study,
      participants will not know which group they are in, but will be able to know once the study
      is finished.

      Participants will be asked to come in for an initial assessment to determine their starting
      visual abilities and medical history. On the next appointment, participants will receive the
      first treatment injections. They will be asked to come into the clinic every month for six
      (6) months total for treatment injections and testing. At each appointment, study
      investigators will take 3-D images of the retina (the back of the eye) using an Optical
      Coherence Tomography (OCT) imaging device, test eye pressure and determine if there are any
      signs of infection or inflammation from the injections. On months 1, 3 and 6 investigators
      will also test vision using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity
      charts, 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
      see blood vessels. Before every treatment, anesthetic eye drops (proparacaine) will be
      applied to the eye so participants will not feel the injections. Participants will be given
      antibiotic eye drops (Zymar®) and will be asked to apply the drops 4 times a day for a few
      days after the injection to prevent infection.
    

Intervention name(s): Ranibizumab; OZURDEX
Intervention type(s): Drug; 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.; OZURDEX injection of 0.7mg dosage at months 0 with follow up for a total of 6 months.
Other intervention name(s): Lucentis; Dexamethasone
Intervention MeSH terms: Dexamethasone; Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Macular Degeneration; Age-related macular degeneration; Anti-inflammatory; Anti-vascular endothelial growth factor (Anti-VEGF); Lucentis; Ranibizumab; OZURDEX; Dexamethasone; Vision loss