Central Retinal Vein OcclusionPhase 2/3NCT00532142
The ROVO Study: Radial Optic Neurotomy for CVO
A Phase 2/3 study testing Intravitreal Triamcinolone and Radial Optic Neurotomy in people with Central Retinal Vein Occlusion, run by Rudolf Foundation Clinic at 1 site in Austria.
Trial summary
The ROVO study is a prospective, placebocontrolled and randomised study designed to evaluate the effect of radial optic neurotomy in central vein occlusion, versus triamcinolone acetonide. 240 patients with a visual acuity < 0.5 Snellen will be randomised. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion
- What is being tested?
- Intravitreal Triamcinolone and Radial Optic Neurotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteAustria
- Study dates
- Apr 2005to Aug 2009
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Onset of CVO not longer than 12 months
- On FLA 1. nonperfused - (greater than 10 disc area of nonperfusion) 2. perfused - visual acuity lower than 0.1 Snellen,or 3. perfused with no improvement of visual acuity over 4 weeks)
Who cannot join
- • Dense cataract* (grade 3 and 4) which precludes judgement of the fundus.
- Pregnancy
- Allergy against Fluoresceine or Indocyanine green
- Unable to come for follow up visit
- Presence of other severe retinopathy or
- Presence of advanced optic atrophy or uncontrolled glaucoma.
- Visual acuity higher than 0.5 Snellen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Trial for Surgical Treatment of Central Retinal Vein Occlusion - Radial Optic Neurotomy for CVO The ROVO Study
The ROVO study is a prospective, placebocontrolled and randomised study designed to evaluate the effect of radial optic neurotomy in central vein occlusion, versus triamcinolone acetonide. 240 patients with a visual acuity < 0.5 Snellen will be randomised. Patients are treated with either RON, or a single intravitreal injection of 4 mg triamcinolone acetonide, or a placebo treatment - a "sham" injection of intravitreal triamcinolone. Patients will be examined regularly over a period of one year.
Best corrected visual acuity for far and near, as well as clinical examinations, fluorescein- and indocyanine green angiograms, optical coherence tomography, and perimetry, are performed pre- and postoperatively.
- Conditions
- Central Retinal Vein Occlusion
- Being tested
- Intravitreal Triamcinolone, Radial Optic Neurotomy, Placebo - Sham Intravitreal Injection
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal TriamcinoloneDrug
Radial Optic NeurotomyProcedure or surgery
Placebo - Sham Intravitreal InjectionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eyes with an improvement of more than 15 letters (approximately > 3 lines of visual acuity gain) after one year as compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startApr 2005
- Study completionAug 2009
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 Central 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- Rudolf Foundation Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Susanne Binder, M.D., Study chair, no affiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532142
- Sponsor's protocol ID
- EK-04-010-0204
- Status last verified
- Oct 2009
- First submitted
- 18 Sep 2007
- Last updated
- 30 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Aggermann T, Brunner S, Krebs I, Haas P, Womastek I, Brannath W, Binder S; ROVO Study Group. A prospective, randomised, multicenter trial for surgical treatment of central retinal vein occlusion: results of the Radial Optic Neurotomy for Central Vein Occlusion (ROVO) study group. Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1065-72. doi: 10.1007/s00417-012-2134-1. Epub 2012 Sep 8.
PubMed 22960949
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Trial for Surgical Treatment of Central Retinal Vein Occlusion - Radial Optic Neurotomy for CVO The ROVO Study
- ClinicalTrials.gov ID
- NCT00532142
- Acronym / sponsor ID
- EK-04-010-0204
- Conditions
- Central Retinal Vein Occlusion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Rudolf Foundation ClinicUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Aug 2009 (actual)
- First posted
- 20 Sep 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 ROVO study is a prospective, placebocontrolled and randomised study designed to evaluate the effect of radial optic neurotomy in central vein occlusion, versus triamcinolone acetonide. 240 patients with a visual acuity < 0.5 Snellen will be randomised. Patients are treated with either RON, or a single intravitreal injection of 4 mg triamcinolone acetonide, or a placebo treatment - a "sham" injection of intravitreal triamcinolone. Patients will be examined regularly over a period of one year.
Best corrected visual acuity for far and near, as well as clinical examinations, fluorescein- and indocyanine green angiograms, optical coherence tomography, and perimetry, are performed pre- and postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Onset of CVO not longer than 12 months
- On FLA 1. nonperfused - (greater than 10 disc area of nonperfusion) 2. perfused - visual acuity lower than 0.1 Snellen,or 3. perfused with no improvement of visual acuity over 4 weeks)
Key exclusion criteria (7 listed)
- • Dense cataract* (grade 3 and 4) which precludes judgement of the fundus.
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 |
|---|---|---|
| Intravitreal Triamcinolone | Drug | – |
| Radial Optic Neurotomy | Procedure or surgery | – |
| Placebo - Sham Intravitreal Injection | Other | – |
Primary outcome
Proportion of eyes with an improvement of more than 15 letters (approximately > 3 lines of visual acuity gain) after one year as compared to baseline
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 30 Oct 2009.
- Derived from this study: PubMed 22960949Aggermann T, Brunner S, Krebs I, Haas P, Womastek I, Brannath W, Binder S; ROVO Study Group. A prospective, randomised, multicenter trial for surgical treatment of central retinal vein occlusion: results of the Radial Optic Neurotomy for Central Vein Occlusion (ROVO) study group. Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1065-72. doi: 10.1007/s00417-012-2134-1. Epub 2012 Sep 8.
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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.
Susanne Binder, M.D. study chair
no affiliation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intravitreal Triamcinolone and Radial Optic Neurotomy in people with Central Retinal Vein Occlusion, run by Rudolf Foundation Clinic at 1 site in Austria.
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 2 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 30 Oct 2009. 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 Austria. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
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?
Proportion of eyes with an improvement of more than 15 letters (approximately > 3 lines of visual acuity gain) after one year as compared to baseline. 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 NCT00532142, 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 30 Oct 2009.