OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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. OZURDEX, 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 OZURDEX 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborators: Hamilton Health Sciences Corporation; St. Joseph's Healthcare Hamilton
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ranibizumab

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