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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by McMaster University
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01243086
First received: November 5, 2010
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Wet Macular Degeneration
Drug: Ranibizumab
Drug: OZURDEX
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Ranibizumab
Ranibizumab is the current gold standard treatment for wet age-related macular degeneration. This intervention is approved by Health Canada, covered by OHIP (Ontario Health Insurance Plan) and used regularly by ophthalmologists in Canada. Participants will receive intravitreal injections of ranibizumab each month for up to 6 months, with ocular testing at each appointment as prescribed by the study protocol.
Drug: Ranibizumab
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 Name: Lucentis
Active Comparator: Ranibizumab and OZURDEX
Recent research has discovered that persons with wet or dry ARMD show an immune response, as if the body is fighting off an infection. The body creates a complex immune response to the growth of blood vessels into the eye tissue, which triggers side effects. It is believed that preventing this inflammation can lead to greater visual gains and a need for fewer treatment injections. Animal studies have shown that Triamcinolone Acetonide, a corticosteroid (class of drugs that reduce inflammation) can prevent damage to vision from this inflammation. The hypothesis is that treatment with both Ranibizumab and OZURDEX will allow even greater vision improvements than Ranibizumab treatment alone for wet age-related macular degeneration.
Drug: OZURDEX
OZURDEX injection of 0.7mg dosage at months 0 with follow up for a total of 6 months.
Other Name: Dexamethasone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with wet age-related macular degeneration (ARMD) with evidence of sub-foveal choroidal neo-vascularization (CNV)
  • Patients greater than the age 18 years old (male or female)
  • Visual acuity must be between 20/40 and 20/320 in the study eye.

Exclusion Criteria:

  • Patients with CNV from causes other than ARMD
  • Patients having intra-ocular surgery within past 3 months on study eye
  • Patients with medically uncontrolled glaucoma
  • Patients with prior vitreous/retinal surgery
  • Patients with a history of past CNV treatment in study eye
  • Patients with other ocular conditions causing vision loss that could confound the analysis of ARMD
  • Individuals with a disability preventing accurate vision testing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243086

Contacts
Contact: Varun Chaudhary, M.D., FRCSC 905-573-7777 ext 38058 vchaudha@uwo.ca
Contact: Joshua Barbosa 905-573-7777 ext 38070 surghrs@mcmaster.ca

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton Regional Eye Centre Recruiting
Hamilton, Ontario, Canada, L8G 5E4
Contact: Varun Chaudhary, MD, FRCSC    905-573-7777 ext 38058    vchaudha@uwo.ca   
Contact: Joshua Barbosa    905-573-7777 ext 38070    surghrs@mcmaster.ca   
Principal Investigator: Varun Chaudhary, MD, FRCSC         
Sub-Investigator: Emmanuel Mavrikakis, MD, PhD         
Sub-Investigator: Forough Farrokhyar, PhD         
Sub-Investigator: Joshua Barbosa         
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Varun Chaudhary, M.D., FRCSC McMaster University
  More Information

Publications:
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01243086     History of Changes
Other Study ID Numbers: STARP2SJHH
Study First Received: November 5, 2010
Last Updated: March 6, 2014
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by McMaster University:
Macular Degeneration
Age-related macular degeneration
Anti-inflammatory
Anti-vascular endothelial growth factor (Anti-VEGF)
Lucentis
Ranibizumab
OZURDEX
Dexamethasone
Vision loss

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014