Ignite Creation Date:
2024-05-05 @ 11:02 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01243086
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2010-11-05
Brief Title:
OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief 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 eyes 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None