Retinal Vein OcclusionPhase 3ATORVONCT00517257
Atorvastatin for the Treatment of Retinal Vein Occlusion
A Phase 3 study testing Atorvastatin in people with Retinal Vein Occlusion and Retinal Vein Thrombosis, run by University of Toronto at 1 site in Canada.
Trial summary
The ATORVO study is designed to determine whether atorvastatin (Lipitor) can improve vision, when compared to placebo Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Vein Occlusion, Retinal Vein Thrombosis, Central Retinal Vein Occlusion
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2007to Sep 2009
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 40 years and older
- Diagnosed with CRVO or BRVO
- Visual acuity of 20/40 or worse in the affected eye
- Onset of current symptoms of loss of vision within the past 60 days
- Ability to understand spoken English
Who cannot join
- Current use of a statin or fibrate medication
- Known cardiovascular disease or revascularization, including coronary artery disease (myocardial infarction or angina), stroke or peripheral artery occlusion
- Known diabetes mellitus
- Known liver disease
- Serum low-density lipoprotein cholesterol (LDL-C) > 5.0 mmol/L
- Baseline serum triglycerides > 6.0 mmol/L
Show all 16Show fewer
- Serum ALT above 115 U/L (i.e., 2.5 x upper limit of normal)
- Baseline serum creatinine > 250 µmol/L
- Ocular surgery within the past 90 days
- Planned ocular or cataract surgery within the study period
- Known retinal disease: age-related macular degeneration, retinal detachment or macular hole, or past history of vein occlusion
- Women who are pregnant or who are breastfeeding
- Participation in another clinical trial concurrently or within 30 days prior to screening
- Known allergy to fluorescein dye
- Current use of cyclosporine medication.
- Current use of an HIV protease inhibitor medication.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Brigita Zile, RN CCRP, 416-864-6060 ext. 4130, zileb@smh.toronto.on.ca
Joel G Ray, MD MSc
About this study
Official title: Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)
The ATORVO study is designed to determine whether atorvastatin (Lipitor) can improve vision, when compared to placebo
Read the detailed description
Retinal vein occlusion (RVO), a common cause of visual loss in the Western world, is a disease whose etiology resembles that of classic atherosclerosis. A therapy that lowers the risk of arterial and venous thrombosis would seem to be a reasonable approach to managing this disease, for which there is currently no treatment.
ATORVO is a randomized double-masked clinical trial comparing a daily dose of 80 mg of atorvastatin to matched placebo in persons recently diagnosed with RVO. At 24 weeks after randomization, we will evaluate each participant's visual acuity and the presence of secondary complications related to RVO.
- Conditions
- Retinal Vein Occlusion, Retinal Vein Thrombosis, Central Retinal Vein Occlusion, Branch Retinal Vein Occlusion, Thrombosis
- Being tested
- Atorvastatin, Placebo
- Keywords
- Retinal vein occlusion, Retinal vein thrombosis, Central retinal vein occlusion, Branch retinal vein occlusion, Visual loss, Atorvastatin, Statin, Neovascularization, Thrombosis
- Medical subject headings
- Retinal Vein Occlusion, Thrombosis, Vision Disorders, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
80 mg orally once daily for 24 weeks
PlaceboDrug
Placebo tablet orally once daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Atorvastatin 80 mg orally once daily for 24 weeks Receives: Drug: Atorvastatin |
| P | Placebo comparator | Placebo tablet orally once daily for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in improvement of at least 15 letters (3 lines) in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity in the affected eye at 24 weeks in patients on active treatment vs. placebo.
Measured: 24 weeks
Secondary outcomes (5)
Prevention of ocular neovascularization or need for laser treatment by 24 weeks.
Measured: 24 weeks
Reduction in macular edema, measured by optical coherence tomography at 24 weeks.
Measured: 24 weeks
Mean change in The National Eye Institute 25-Item Visual Function Questionnaire-25 (VFQ-25) score from 0 to 24 weeks.
Measured: 24 weeks
Composite of non-fatal myocardial infarction, hospitalization for acute coronary syndrome, receipt of coronary revascularization, stroke or death, by 52 weeks.
Measured: 24 weeks
Mean change in the concentration of serum total cholesterol, LDL-cholesterol and highly sensitive C-reactive protein at 0 and 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startAug 2007
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, Pfizer, Canadian Heart Research Centre, Ontario Association of Optometrists, Toronto Ophthalmological Society
- Investigators
- Joel G Ray, MD MSc, Principal investigator, St. Michael's Hospital, University of TorontoDavid Wong, MD, Principal investigator, St. Michael's Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517257
- Sponsor's protocol ID
- NRA2580025
- Acronym
- ATORVO
- Status last verified
- Jun 2008
- First submitted
- 14 Aug 2007
- Last updated
- 25 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin Toronto Retinal Vein Occlusion Study (ATORVO)
- ClinicalTrials.gov ID
- NCT00517257
- Acronym / sponsor ID
- ATORVO / NRA2580025
- Conditions
- Retinal Vein Occlusion, Retinal Vein Thrombosis, Central Retinal Vein Occlusion, Branch Retinal Vein Occlusion, Thrombosis
- Keywords
- Retinal vein occlusion, Retinal vein thrombosis, Central retinal vein occlusion, Branch retinal vein occlusion, Visual loss, Atorvastatin, Statin, Neovascularization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Unity Health Toronto, Pfizer, Canadian Heart Research Centre, Ontario Association of Optometrists, Toronto Ophthalmological Society
- Study start
- Aug 2007
- Study completion
- Sep 2009 (estimated)
- First posted
- 16 Aug 2007 (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.
The ATORVO study is designed to determine whether atorvastatin (Lipitor) can improve vision, when compared to placebo
Detailed description
Retinal vein occlusion (RVO), a common cause of visual loss in the Western world, is a disease whose etiology resembles that of classic atherosclerosis. A therapy that lowers the risk of arterial and venous thrombosis would seem to be a reasonable approach to managing this disease, for which there is currently no treatment.
ATORVO is a randomized double-masked clinical trial comparing a daily dose of 80 mg of atorvastatin to matched placebo in persons recently diagnosed with RVO. At 24 weeks after randomization, we will evaluate each participant's visual acuity and the presence of secondary complications related to RVO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AtorvastatinAtorvastatin 80 mg orally once daily for 24 weeks |
| P | Placebo comparator | Drug: PlaceboPlacebo tablet orally once daily for 24 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 40 years and older
- Diagnosed with CRVO or BRVO
- Visual acuity of 20/40 or worse in the affected eye
- Onset of current symptoms of loss of vision within the past 60 days
- Ability to understand spoken English
Key exclusion criteria (16 listed)
- Current use of a statin or fibrate medication
- Known cardiovascular disease or revascularization, including coronary artery disease (myocardial infarction or angina), stroke or peripheral artery occlusion
- Known diabetes mellitus
- Known liver disease
- Serum low-density lipoprotein cholesterol (LDL-C) > 5.0 mmol/L
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 |
|---|---|---|
| AtorvastatinAlso: Lipitor80 mg orally once daily for 24 weeks | Drug | A |
| PlaceboPlacebo tablet orally once daily for 24 weeks | Drug | P |
Primary outcome
Difference in improvement of at least 15 letters (3 lines) in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity in the affected eye at 24 weeks in patients on active treatment vs. placebo.
Time frame: 24 weeks
5 secondary outcomes
Prevention of ocular neovascularization or need for laser treatment by 24 weeks.
Time frame: 24 weeks
Reduction in macular edema, measured by optical coherence tomography at 24 weeks.
Time frame: 24 weeks
Mean change in The National Eye Institute 25-Item Visual Function Questionnaire-25 (VFQ-25) score from 0 to 24 weeks.
Time frame: 24 weeks
Composite of non-fatal myocardial infarction, hospitalization for acute coronary syndrome, receipt of coronary revascularization, stroke or death, by 52 weeks.
Time frame: 24 weeks
Mean change in the concentration of serum total cholesterol, LDL-cholesterol and highly sensitive C-reactive protein at 0 and 24 weeks.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2008.
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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.
Joel G Ray, MD MSc principal investigator
St. Michael's Hospital, University of Toronto
David Wong, MD principal investigator
St. Michael's Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin in people with Retinal Vein Occlusion and Retinal Vein Thrombosis, run by University of Toronto 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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 25 Jun 2008. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brigita Zile Zile, RN (416-864-6060 ext. 4130, zileb@smh.toronto.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in improvement of at least 15 letters (3 lines) in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity in the affected eye at 24 weeks in patients on active treatment vs. placebo. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2008; AzTrials last refreshed its copy on 26 Oct 2026.