Wet Macular Degeneration | Sub-tenon Triamcinolone Acetonide in Age-Related Macular Degeneration as Adjunct to Ranibizumab
Wet Macular Degeneration research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Wet Macular Degeneration
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:RanibizumabIntra-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.
Drug:Triamcinolone AcetonideSub-tenon injection of 40mg/mL dosage at months 0 and 2 with follow up for a total of 6 months.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
RanibizumabRanibizumab 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.
Ranibizumab and Triamcinolone acetonideRecent 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.
Start Date: January 2011
Completed Date: October 2011
Phase: Phase 2
Primary Outcome: Gains in visual acuity
Secondary Outcome: Changes in intra-ocular pressure
Study sponsors, principal investigator, and references
Principal Investigator: Wai-Ching Lam, MD, FRCSC
Lead Sponsor: University Health Network, Toronto
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.