OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab

NCT01243086 | Completed Phase 2

• 1 other identifier: STARP2SJHH
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Wet Macular Degeneration

Keywords

Macular Degeneration; Age-related macular degeneration; Anti-inflammatory; Anti-vascular endothelial growth factor (Anti-VEGF); Lucentis; Ranibizumab; OZURDEX; Dexamethasone; Vision loss

Outcome Measures

Primary Outcomes (1)

• Gains in visual acuity

  Gains in visual acuity will be assessed by comparing best corrected visual acuity at each follow up appointment by the standardized vision testing, early treatment diabetic retinopathy study (ETDRS) visual acuity test. The ETDRS visual acuity test was first developed to effectively evaluate visual changes following panretinal photocoagulation in patients with diabetic retinopathy. This method of measuring visual acuity was more accurate than previous methods, and thus has become the global standard, especially for clinical trials where it is essential to have utmost accuracy.

  Baseline and months 1, 2, 3, 4, 5, and 6

Secondary Outcomes (5)

• Changes in intraocular pressure

  Baseline and months 1, 2, 3, 4, 5 and 6

• Rates of re-treatment

  Months 1, 2, 3, 4, 5 and 6

• Rate of vision loss

  Baseline and months 1, 2, 3, 4, 5 and 6

• Rate of cataract progression

  Baseline and months 1, 2, 3, 4, 5, and 6

• Changes in choroid vessel activity in lesion growth and activity at choroid

  Baseline and months 1, 2, 3, 4, 5 and 6

Study Arms (2)

Ranibizumab

PLACEBO COMPARATOR

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.

Drug: Ranibizumab

Ranibizumab and OZURDEX

ACTIVE COMPARATOR

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 OZURDEX will allow even greater vision improvements than Ranibizumab treatment alone for wet age-related macular degeneration.

Drug: OZURDEX

Interventions

Ranibizumab DRUG

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.

Also known as: Lucentis

Ranibizumab

OZURDEX DRUG

OZURDEX injection of 0.7mg dosage at months 0 with follow up for a total of 6 months.

Also known as: Dexamethasone

Ranibizumab and OZURDEX

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton Regional Eye Centre

Hamilton, Ontario, L8G 5E4, Canada

Location

Related Publications (1)

• 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. doi: 10.1016/j.ophtha.2007.02.013.

  PMID: 18054638 BACKGROUND

MeSH Terms

Conditions

Wet Macular Degeneration; Macular Degeneration; Vision Disorders

Interventions

Ranibizumab; Calcium Dobesilate; Dexamethasone

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Varun Chaudhary, M.D., FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 18, 2010
• Study Start: March 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 6, 2018

Record last verified: 2015-04

Locations

CA (1)