Recruiting
Phase 2

Triamcinolone with Ranibizumab

Sponsor:

University Health Network, Toronto

Code:

NCT01249937

Conditions

Wet Macular Degeneration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ranibizumab

Triamcinolone Acetonide

Study Details

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.

Conditions

Wet Macular Degeneration

Study ID

NCT01249937

Start date

Jan, 2011

Status verified date

Jan, 2011

Completion date

Oct, 2011

Anticipated

Primary completion date

Jul, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Ranibizumab

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

Sub-tenon injection of 40mg/mL dosage at months 0 and 2 with follow up for a total of 6 months.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University Health Network-Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 9, 2011

Last verified

Jan, 2011

Keywords

  • Macular Degeneration
  • Age-related macular degeneration
  • Anti-inflammatory
  • Anti-vascular endothelial growth factor (Anti-VEGF)
  • Lucentis
  • Ranibizumab
  • Kenalog
  • Triamcinolone Acetonide
  • Vision loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2011-02-09.