Central Retinal Vein OcclusionLuRVONCT01360385
Retinal Ischemia in Central Retinal Vein Occlusion, and the Effects of Treatment With Intravitreal Ranibizumab
An observational study of Central Retinal Vein Occlusion, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Recent studies have shown a remarkably positive effect of 6 monthly injections of Ranibizumab on eyes with CRVO. The disease may cause severe sight threatening complications, partly due to restrictions in blood flow and oxygenation . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Jul 2012
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed central retinal vein occlusion who have planned treatment with intravitreal renibizumab
Who may be able to join
- Central retinal vein occlusion in one eye.
- Planned treatment with intravitreal injections of Lucentis (ranibizumab)
- Functional fellow eye.
Who cannot join
- Current or previous medical condition that in the opinion of the investigator may confound assessment of study results or put where the study methods may put the patient at risk.
- Patients who are unable to receive treatment with vascular endothelial growth factor inhibitors.
- Prior panretinal photocoagulation in the study eye.
- Prior intraocular surgery in the study eye, other than cataract operation.
- Any intravitreal injection 6 months prior to study baseline
- Participation in another clinical study that, in the opinion of the investigator, may confound the assessment of study results.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Glostrup Hospital
Copenhagen, Glostrup, 2600
About this study
Official title: Objective Measurement of Retinal Ischemia in Central Retinal Vein Occlusion, and the Effects of Treatment With a Vascular Endothelial Growth Factor Inhibitor.
Recent studies have shown a remarkably positive effect of 6 monthly injections of Ranibizumab on eyes with CRVO. The disease may cause severe sight threatening complications, partly due to restrictions in blood flow and oxygenation . Although Ranibizumab has been shown affective to reduce oedema of the retina, it is not known whether the drug ameliorates or aggravates restrictions in oxygenation.
The Oxymap oximeter allows a non-invasive measurement of the oxygen saturation in retinal vessels and thus the state of retinal oxygenation.
Read more
The primary objective of the study is to evaluate the effects of injections of Ranibizumab on the retinal oxygen saturation in eyes with newly diagnosed central retinal vein occlusion (CRVO),
The secondary objective is to evaluate the effects of injections of Ranibizumab on visual acuity and retinal oedema in eyes with different degree of ischemia.
Read the detailed description
Background and objectives
The CRUISE study has shown a remarkable positive effect of 6 monthly injections intravitreal Ranibizumab on visual function in eyes with macular edema secondary to CRVO. Eyes with CRVO are at risk of severe complications to retinal ischemia, particularly proliferative retinopathy and neovascular glaucoma. It is not known whether intravitreal anti-VEGF therapy ameliorates or aggravates retinal ischemia and thus the risk of ischemic complications is unknown. Since complications to retinal ischemia take time to develop, and are relatively infrequent, the CRUISE study was not designed, or powered, to investigate the impact of intravitreal anti-VEGF treatment on these complications.
The Oxymap oximeter allows objective non-invasive measurement of the oxygen saturation in retinal vessels and thus the degree of retinal ischemia. The rationale behind the present study is to use this instrument in order to obtain preliminary information on the effects of intravitreal anti-VEGF treatment on retinal ischemia in CRVO eyes without having to wait for ischemic complications to arise in a large study population.
The primary objective of the study is to evaluate the effects of treatment with intravitreal Ranibizumab on the retinal oxygen saturation in eyes with newly diagnosed central retinal vein occlusion (CRVO),
The secondary objective is to evaluate the effects of intravitreal Ranibizumab on visual acuity and central retinal thickness in eyes with different degree of ischemia.
Study design
The research project is a case-series study of CRVO-patients with three monthly injections of Ranibizumab and a 3 month follow-up period, during which Ranibizumab injections are provided as needed.
- Conditions
- Central Retinal Vein Occlusion
- Keywords
- Central retinal rein occlusion, Retinal oximetry, Oxymap Retinal Oximeter, Visual acuity, Central retinal thickness
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Central Retinal Vein Occlusion | CRVO-patients with planned treatment with intravitreal injections of ranibizumab, who receive three monthly injections of ranibizumab and a 3 month follow-up period, during which ranibizumab injections are provided as needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal oxygen saturation
Oxygen saturation is measured with the Oxymap Retinal Oximeter, which allows for objective, non-invase oximetry in retinal vessel.
The outcome measure will be the change in saturation from baseline to 6 months after first injection.
Measured: 6 months after first injection of ranibizumab.
Secondary outcomes (2)
Visual acuity
Visual acuity measured by the ETDRS standard at 4 meters, 2 meters and 1 meter, where applicable.
The outcome measure will be the mean change in visual acuity, measured in ETDRS letters, from baseline to 6 months after first injection.
Measured: 6 months after first injection of ranibizumab.
Central retinal thickness
Central retinal thickness as measured with optical coherence tomography.
The outcome measure will be the mean change in central retinal thickness, from baseline to 6 months after first injection.
Measured: 6 months after first injection of ranibizumab.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startOct 2010
- Primary completionJul 2012
- Study completionJul 2012
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Sindri Traustason, Glostrup University Hospital, Copenhagen
- Investigators
- Morten D la Cour, MD, DMsc, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360385
- Sponsor's protocol ID
- LuRVO
- Acronym
- LuRVO
- Status last verified
- Sep 2012
- First submitted
- 28 Oct 2010
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Traustason S, la Cour M, Larsen M. Retinal vascular oximetry during ranibizumab treatment of central retinal vein occlusion. Br J Ophthalmol. 2014 Sep;98(9):1208-11. doi: 10.1136/bjophthalmol-2013-304580. Epub 2014 Apr 12.
PubMed 24729079
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Measurement of Retinal Ischemia in Central Retinal Vein Occlusion, and the Effects of Treatment With a Vascular Endothelial Growth Factor Inhibitor.
- ClinicalTrials.gov ID
- NCT01360385
- Acronym / sponsor ID
- LuRVO / LuRVO
- Conditions
- Central Retinal Vein Occlusion
- Keywords
- Central retinal rein occlusion, Retinal oximetry, Oxymap Retinal Oximeter, Visual acuity, Central retinal thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Oct 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 May 2011 (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.
Recent studies have shown a remarkably positive effect of 6 monthly injections of Ranibizumab on eyes with CRVO. The disease may cause severe sight threatening complications, partly due to restrictions in blood flow and oxygenation . Although Ranibizumab has been shown affective to reduce oedema of the retina, it is not known whether the drug ameliorates or aggravates restrictions in oxygenation.
The Oxymap oximeter allows a non-invasive measurement of the oxygen saturation in retinal vessels and thus the state of retinal oxygenation.
The primary objective of the study is to evaluate the effects of injections of Ranibizumab on the retinal oxygen saturation in eyes with newly diagnosed central retinal vein occlusion (CRVO),
The secondary objective is to evaluate the effects of injections of Ranibizumab on visual acuity and retinal oedema in eyes with different degree of ischemia.
Detailed description
Background and objectives
The CRUISE study has shown a remarkable positive effect of 6 monthly injections intravitreal Ranibizumab on visual function in eyes with macular edema secondary to CRVO. Eyes with CRVO are at risk of severe complications to retinal ischemia, particularly proliferative retinopathy and neovascular glaucoma. It is not known whether intravitreal anti-VEGF therapy ameliorates or aggravates retinal ischemia and thus the risk of ischemic complications is unknown. Since complications to retinal ischemia take time to develop, and are relatively infrequent, the CRUISE study was not designed, or powered, to investigate the impact of intravitreal anti-VEGF treatment on these complications.
The Oxymap oximeter allows objective non-invasive measurement of the oxygen saturation in retinal vessels and thus the degree of retinal ischemia. The rationale behind the present study is to use this instrument in order to obtain preliminary information on the effects of intravitreal anti-VEGF treatment on retinal ischemia in CRVO eyes without having to wait for ischemic complications to arise in a large study population.
The primary objective of the study is to evaluate the effects of treatment with intravitreal Ranibizumab on the retinal oxygen saturation in eyes with newly diagnosed central retinal vein occlusion (CRVO),
The secondary objective is to evaluate the effects of intravitreal Ranibizumab on visual acuity and central retinal thickness in eyes with different degree of ischemia.
Study design
The research project is a case-series study of CRVO-patients with three monthly injections of Ranibizumab and a 3 month follow-up period, during which Ranibizumab injections are provided as needed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Central Retinal Vein Occlusion | – | –CRVO-patients with planned treatment with intravitreal injections of ranibizumab, who receive three monthly injections of ranibizumab and a 3 month follow-up period, during which ranibizumab injections are provided as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed central retinal vein occlusion who have planned treatment with intravitreal renibizumab
Key inclusion criteria (3 listed)
- Central retinal vein occlusion in one eye.
- Planned treatment with intravitreal injections of Lucentis (ranibizumab)
- Functional fellow eye.
Key exclusion criteria (6 listed)
- Current or previous medical condition that in the opinion of the investigator may confound assessment of study results or put where the study methods may put the patient at risk.
- Patients who are unable to receive treatment with vascular endothelial growth factor inhibitors.
- Prior panretinal photocoagulation in the study eye.
- Prior intraocular surgery in the study eye, other than cataract operation.
- Any intravitreal injection 6 months prior to study baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal oxygen saturation
Time frame: 6 months after first injection of ranibizumab.
Oxygen saturation is measured with the Oxymap Retinal Oximeter, which allows for objective, non-invase oximetry in retinal vessel. The outcome measure will be the change in saturation from baseline to 6 months after first injection.
2 secondary outcomes
Visual acuity
Time frame: 6 months after first injection of ranibizumab.
Central retinal thickness
Time frame: 6 months after first injection of ranibizumab.
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 12 Sep 2012.
- Derived from this study: PubMed 24729079Traustason S, la Cour M, Larsen M. Retinal vascular oximetry during ranibizumab treatment of central retinal vein occlusion. Br J Ophthalmol. 2014 Sep;98(9):1208-11. doi: 10.1136/bjophthalmol-2013-304580. Epub 2014 Apr 12.
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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.
Morten D la Cour, MD, DMsc principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Retinal Vein Occlusion, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 6 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 12 Sep 2012. 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 Denmark. 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.
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?
Retinal oxygen saturation (time frame: 6 months after first injection of ranibizumab.). 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 NCT01360385, 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 12 Sep 2012.