Retinal Ischemia in Central Retinal Vein Occlusion, and the Effects of Treatment With Intravitreal Ranibizumab
NCT ID: NCT01360385
Last Updated: 2012-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2010-10-31
2012-07-31
Brief Summary
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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
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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
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Planned treatment with intravitreal injections of Lucentis (ranibizumab)
3. Functional fellow eye.
Exclusion Criteria
2. Patients who are unable to receive treatment with vascular endothelial growth factor inhibitors.
3. Prior panretinal photocoagulation in the study eye.
4. Prior intraocular surgery in the study eye, other than cataract operation.
5. Any intravitreal injection 6 months prior to study baseline
6. Participation in another clinical study that, in the opinion of the investigator, may confound the assessment of study results.
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Glostrup University Hospital, Copenhagen
OTHER
Responsible Party
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Sindri Traustason
Cand. Scient.
Principal Investigators
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Morten D la Cour, MD, DMsc
Role: PRINCIPAL_INVESTIGATOR
Locations
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Department of Ophthalmology, Glostrup Hospital
Copenhagen, Glostrup, Denmark
Countries
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References
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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.
Other Identifiers
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LuRVO
Identifier Type: -
Identifier Source: org_study_id