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

Sponsor
University Health Network, Toronto
Study ID
NCT01249937
Phase
PHASE2
Status
Unknown

Conditions

  • Wet Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    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.
  • Triamcinolone Acetonide — DRUG
    Sub-tenon injection of 40mg/mL dosage at months 0 and 2 with follow up for a total of 6 months.

Study Details

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.

Key Dates

First listed
Nov 30, 2010
Start date
Jan 31, 2011
Status verified
Jan 2011
Primary completion
Jul 31, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Gains in visual acuity [ Time Frame: Baseline and months 1, 2, 3, 4, 5, and 6 ]

Central Contacts

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