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Monoclonal Antibodies

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

Phase 2
Waitlist Available
Led By Wai-Ching Lam, MD, FRCSC
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1, 2, 3, 4, 5 and 6
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

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.

Eligible Conditions
  • Age-Related Macular Degeneration

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1, 2, 3, 4, 5 and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1, 2, 3, 4, 5 and 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Gains in visual acuity
Secondary study objectives
Changes in intra-ocular pressure
Rate of cataract progression
Rate of vision loss
+2 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Ranibizumab and Triamcinolone acetonideActive Control2 Interventions
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.
Group II: RanibizumabPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,292 Total Patients Enrolled
Wai-Ching Lam, MD, FRCSCPrincipal InvestigatorUniversity Health Network, Toronto Western Hospital
~2 spots leftby Dec 2025