OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab (STAR)

• Gains in visual acuity [ Time Frame: Baseline and months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
  Gains in visual acuity will be assessed by comparing best corrected visual acuity at each follow up appointment by the standardized vision testing, early treatment diabetic retinopathy study (ETDRS) visual acuity test. The ETDRS visual acuity test was first developed to effectively evaluate visual changes following panretinal photocoagulation in patients with diabetic retinopathy. This method of measuring visual acuity was more accurate than previous methods, and thus has become the global standard, especially for clinical trials where it is essential to have utmost accuracy.
  
  

• Changes in intraocular pressure [ Time Frame: Baseline and months 1, 2, 3, 4, 5 and 6 ] [ Designated as safety issue: Yes ]
  To be measured by tonometry
  
  
• Rates of re-treatment [ Time Frame: Months 1, 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]
  To be measured by recording each drug administration date
  
  
• Rate of vision loss [ Time Frame: Baseline and months 1, 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]
  To be measured by ETDRS visual acuity testing and compared over the course of the study
  
  
• Rate of cataract progression [ Time Frame: Baseline and months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
  Measured at each appointment with a slit lamp examination
  
  
• Changes in choroid vessel activity in lesion growth and activity at choroid [ Time Frame: Baseline and months 1, 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]
  The changes in blood vessel lesion growth and activity will be measured by OCT (Ocular Coherence Tomography) and fundus fluorescein angiography to assess choroidal neovascular leakage
  
  

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.