Wet Macular DegenerationPhase 2STARNCT01243086
OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab
A Phase 2 study testing Ranibizumab and OZURDEX in people with Wet Macular Degeneration, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Wet Macular Degeneration
- What is being tested?
- Ranibizumab and OZURDEX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Healthcare Hamilton Regional Eye Centre
Hamilton, Ontario, L8G 5E4
About this study
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.
Read the detailed description
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.
- Conditions
- Wet Macular Degeneration
- Being tested
- Ranibizumab, OZURDEX
- Keywords
- Macular Degeneration, Age-related macular degeneration, Anti-inflammatory, Anti-vascular endothelial growth factor (Anti-VEGF), Lucentis, Ranibizumab, OZURDEX, Dexamethasone, Vision loss
- Medical subject headings
- Wet Macular Degeneration, Macular Degeneration, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
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.
OZURDEXDrug
Also called Dexamethasone
OZURDEX injection of 0.7mg dosage at months 0 with follow up for a total of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: OZURDEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and months 1, 2, 3, 4, 5, and 6
Secondary outcomes (5)
Changes in intraocular pressure
To be measured by tonometry
Measured: Baseline and months 1, 2, 3, 4, 5 and 6
Rates of re-treatment
To be measured by recording each drug administration date
Measured: Months 1, 2, 3, 4, 5 and 6
Rate of vision loss
To be measured by ETDRS visual acuity testing and compared over the course of the study
Measured: Baseline and months 1, 2, 3, 4, 5 and 6
Rate of cataract progression
Measured at each appointment with a slit lamp examination
Measured: Baseline and months 1, 2, 3, 4, 5, and 6
Changes in choroid vessel activity in lesion growth and activity at choroid
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
Measured: Baseline and months 1, 2, 3, 4, 5 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wet Macular DegenerationStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Varun Chaudhary, M.D., FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243086
- Sponsor's protocol ID
- STARP2SJHH
- Acronym
- STAR
- Status last verified
- Apr 2015
- First submitted
- 5 Nov 2010
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18054638
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab
- ClinicalTrials.gov ID
- NCT01243086
- Acronym / sponsor ID
- STAR / STARP2SJHH
- Conditions
- Wet Macular Degeneration
- Keywords
- Macular Degeneration, Age-related macular degeneration, Anti-inflammatory, Anti-vascular endothelial growth factor (Anti-VEGF), Lucentis, Ranibizumab, OZURDEX, Dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, St. Joseph's Healthcare Hamilton
- Study start
- Mar 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Placebo comparator | Drug: RanibizumabRanibizumab 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. |
| Ranibizumab and OZURDEX | Active comparator | Drug: OZURDEXRecent 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanibizumabAlso: LucentisIntra-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. | Drug | Ranibizumab |
| OZURDEXAlso: DexamethasoneOZURDEX injection of 0.7mg dosage at months 0 with follow up for a total of 6 months. | Drug | Ranibizumab and OZURDEX |
Primary outcome
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.
5 secondary outcomes
Changes in intraocular pressure
Time frame: Baseline and months 1, 2, 3, 4, 5 and 6
Rates of re-treatment
Time frame: Months 1, 2, 3, 4, 5 and 6
Rate of vision loss
Time frame: Baseline and months 1, 2, 3, 4, 5 and 6
Rate of cataract progression
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Changes in choroid vessel activity in lesion growth and activity at choroid
Time frame: Baseline and months 1, 2, 3, 4, 5 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Background: PubMed 18054638Chaudhary 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Varun Chaudhary, M.D., FRCSC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranibizumab and OZURDEX in people with Wet Macular Degeneration, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gains in visual acuity (time frame: Baseline and months 1, 2, 3, 4, 5, and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01243086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.