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Completed

NCT Number: NCT01243086

OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Joseph's Healthcare Hamilton Regional Eye Centre

Hamilton, Ontario, L8G 5E4, Canada

About this study

Age Related Macular Degeneration (ARMD or AMD) is the leading cause of blindness in North America. There are two types of ARMD: dry and wet. Both forms of ARMD cause a progressive loss of central vision, the part of your vision that allows you to read, drive and see images in sharp detail directly in front of you. The wet form is typically more severe and is characterized by the growth and leakage of small blood vessels into the choroid layer of the eye, or the back of the eye. These leaking blood vessels disrupt the structure and function of the eye, causing loss of vision, particularly the sharp vision created by the macula area of the eye.

Upon being accepted to the study, participants will be randomly divided into two groups. One group will receive both ranibizumab and OZURDEX injections and the other group will receive ranibizumab injections and a placebo treatment. To participants in this group, there will be the appearance of a second injection but no actual injection will take place. An individual not connected to the study will assign participants to a group based on a computer-generated system, giving participants at 50% chance of being placed in either group. During the study, participants will not know which group they are in, but will be able to know once the study is finished.

Participants will be asked to come in for an initial assessment to determine their starting visual abilities and medical history. On the next appointment, participants will receive the first treatment injections. They will be asked to come into the clinic every month for six (6) months total for treatment injections and testing. At each appointment, study investigators will take 3-D images of the retina (the back of the eye) using an Optical Coherence Tomography (OCT) imaging device, test eye pressure and determine if there are any signs of infection or inflammation from the injections. On months 1, 3 and 6 investigators will also test vision using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts, contrast sensitivity using a standard contrast sensitivity chart (The Pelli-Robson chart) and take images of the blood vessel growth using a coloured dye (fluorescein) to help see blood vessels. Before every treatment, anesthetic eye drops (proparacaine) will be applied to the eye so participants will not feel the injections. Participants will be given antibiotic eye drops (Zymar®) and will be asked to apply the drops 4 times a day for a few days after the injection to prevent infection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Lucentis

Ozurdex

Drug

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

Other names: Dexamethasone

Primary outcomes

  1. Gains in visual acuity

    Time frame: Baseline and months 1, 2, 3, 4, 5, and 6

    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.

Secondary outcomes

  1. Changes in intraocular pressure

    Time frame: Baseline and months 1, 2, 3, 4, 5 and 6

    To be measured by tonometry

  2. Rates of re-treatment

    Time frame: Months 1, 2, 3, 4, 5 and 6

    To be measured by recording each drug administration date

  3. Rate of vision loss

    Time frame: Baseline and months 1, 2, 3, 4, 5 and 6

    To be measured by ETDRS visual acuity testing and compared over the course of the study

  4. Rate of cataract progression

    Time frame: Baseline and months 1, 2, 3, 4, 5, and 6

    Measured at each appointment with a slit lamp examination

  5. Changes in choroid vessel activity in lesion growth and activity at choroid

    Time frame: Baseline and months 1, 2, 3, 4, 5 and 6

    The changes in blood vessel lesion growth and activity will be measured by OCT (Ocular Coherence Tomography) and fundus fluorescein angiography to assess choroidal neovascular leakage

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Health Sciences Corporation
  • St. Joseph's Healthcare Hamilton

Registry information

Acronym: STAR

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 18, 2010
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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