Sub-tenon Triamcinolone Acetonide in Age-Related Macular Degeneration as Adjunct to Ranibizumab (STAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01249937
First received: November 26, 2010
Last updated: February 8, 2011
Last verified: January 2011
  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. Triamcinolone acetonide, 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 triamcinolone acetonide 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: Triamcinolone Acetonide
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: Sub-tenon Triamcinolone Acetonide in Age-Related Macular Degeneration as Adjunct to Ranibizumab

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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 intra-ocular 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 fluoroscein angiography to assess choroidal neovascular leakage


Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: July 2011 (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 Triamcinolone acetonide

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 Triamcinolone Acetonide will allow even greater vision improvements than Ranibizumab treatment alone for wet age-related macular degeneration.

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
Drug: Triamcinolone Acetonide
Sub-tenon injection of 40mg/mL dosage at months 0 and 2 with follow up for a total of 6 months.
Other Name: Kenalog

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 triamcinolone acetonide 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: NCT01249937

Contacts
Contact: Wai-Ching Lam, MD, FRCSC (416) 603-5376 waiching.lam@utoronto.ca

Locations
Canada, Ontario
University Health Network-Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Wai-Ching Lam, MD, FRCSC    416-603-5376    waiching.lam@utoronto.ca   
Sub-Investigator: Emmanuel Mavrikakis, MD, PhD         
Sub-Investigator: Robert Devenyi, MD, FRCSC         
Sub-Investigator: Sourabh Arora, BSc         
Sub-Investigator: Laura Schneider, BSc         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Wai-Ching Lam, MD, FRCSC University Health Network, Toronto Western Hospital
  More Information

Publications:
Responsible Party: Dr. Wai-Ching Lam, University Health Network-Toronto Western Hospital
ClinicalTrials.gov Identifier: NCT01249937     History of Changes
Other Study ID Numbers: STARP2TWH
Study First Received: November 26, 2010
Last Updated: February 8, 2011
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Macular Degeneration
Age-related macular degeneration
Anti-inflammatory
Anti-vascular endothelial growth factor (Anti-VEGF)
Lucentis
Ranibizumab
Kenalog
Triamcinolone Acetonide
Vision loss

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014