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

Primary Purpose

Wet Macular Degeneration

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Ranibizumab
Triamcinolone Acetonide
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Macular Degeneration focused on measuring Macular Degeneration, Age-related macular degeneration, Anti-inflammatory, Anti-vascular endothelial growth factor (Anti-VEGF), Lucentis, Ranibizumab, Kenalog, Triamcinolone Acetonide, Vision loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Network-Toronto Western HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Ranibizumab

Ranibizumab and Triamcinolone acetonide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Gains in visual acuity
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
To be measured by tonometry
Rates of re-treatment
To be measured by recording each drug administration date
Rate of vision loss
To be measured by ETDRS visual acuity testing and compared over the course of the study
Rate of cataract progression
Measured at each appointment with a slit lamp examination
• Changes in choroid vessel activity in lesion growth and activity at choroid
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

Full Information

First Posted
November 26, 2010
Last Updated
February 8, 2011
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01249937
Brief Title
Sub-tenon Triamcinolone Acetonide in Age-Related Macular Degeneration as Adjunct to Ranibizumab
Acronym
STAR
Official Title
Sub-tenon Triamcinolone Acetonide in Age-Related Macular Degeneration as Adjunct to Ranibizumab
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Macular Degeneration
Keywords
Macular Degeneration, Age-related macular degeneration, Anti-inflammatory, Anti-vascular endothelial growth factor (Anti-VEGF), Lucentis, Ranibizumab, Kenalog, Triamcinolone Acetonide, Vision loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Ranibizumab and Triamcinolone acetonide
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Kenalog
Intervention Description
Sub-tenon injection of 40mg/mL dosage at months 0 and 2 with follow up for a total of 6 months.
Primary Outcome Measure Information:
Title
Gains in visual acuity
Description
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.
Time Frame
Baseline and months 1, 2, 3, 4, 5, and 6
Secondary Outcome Measure Information:
Title
Changes in intra-ocular pressure
Description
To be measured by tonometry
Time Frame
Baseline and months 1, 2, 3, 4, 5 and 6
Title
Rates of re-treatment
Description
To be measured by recording each drug administration date
Time Frame
Months 1, 2, 3, 4, 5 and 6
Title
Rate of vision loss
Description
To be measured by ETDRS visual acuity testing and compared over the course of the study
Time Frame
Baseline and months 1, 2, 3, 4, 5 and 6
Title
Rate of cataract progression
Description
Measured at each appointment with a slit lamp examination
Time Frame
Baseline and months 1, 2, 3, 4, 5, and 6
Title
• Changes in choroid vessel activity in lesion growth and activity at choroid
Description
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
Time Frame
Baseline and months 1, 2, 3, 4, 5 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wai-Ching Lam, MD, FRCSC
Phone
(416) 603-5376
Email
waiching.lam@utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai-Ching Lam, MD, FRCSC
Organizational Affiliation
University Health Network, Toronto Western Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network-Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wai-Ching Lam, MD, FRCSC
Phone
416-603-5376
Email
waiching.lam@utoronto.ca
First Name & Middle Initial & Last Name & Degree
Emmanuel Mavrikakis, MD, PhD
First Name & Middle Initial & Last Name & Degree
Robert Devenyi, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Sourabh Arora, BSc
First Name & Middle Initial & Last Name & Degree
Laura Schneider, BSc

12. IPD Sharing Statement

Citations:
PubMed Identifier
18054638
Citation
Chaudhary V, Mao A, Hooper PL, Sheidow TG. Triamcinolone acetonide as adjunctive treatment to verteporfin in neovascular age-related macular degeneration: a prospective randomized trial. Ophthalmology. 2007 Dec;114(12):2183-9. doi: 10.1016/j.ophtha.2007.02.013.
Results Reference
background

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

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