- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01360385
Retinal Ischemia in Central Retinal Vein Occlusion, and the Effects of Treatment With Intravitreal Ranibizumab (LuRVO)
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.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Glostrup
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Copenhagen, Glostrup, Denmark, 2600
- Department of Ophthalmology, Glostrup Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Central retinal vein occlusion in one eye.
- Planned treatment with intravitreal injections of Lucentis (ranibizumab)
- Functional fellow eye.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Retinal oxygen saturation
Time Frame: 6 months after first injection of ranibizumab.
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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. |
6 months after first injection of ranibizumab.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity
Time Frame: 6 months after first injection of ranibizumab.
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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. |
6 months after first injection of ranibizumab.
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Central retinal thickness
Time Frame: 6 months after first injection of ranibizumab.
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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. |
6 months after first injection of ranibizumab.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Morten D la Cour, MD, DMsc
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LuRVO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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