Sub-tenon Triamcinolone Acetonide in Age-Related Macular Degeneration as Adjunct to Ranibizumab (STAR)
Wet Macular Degeneration
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
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
Placebo Comparator
Active Comparator
Ranibizumab
Ranibizumab and Triamcinolone acetonide
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.