Retinal Ischemia in Central Retinal Vein Occlusion, and the Effects of Treatment With Intravitreal Ranibizumab (LuRVO)

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Sindri Traustason, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01360385
First received: October 28, 2010
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition
Central Retinal Vein Occlusion

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Objective Measurement of Retinal Ischemia in Central Retinal Vein Occlusion, and the Effects of Treatment With a Vascular Endothelial Growth Factor Inhibitor.

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Retinal oxygen saturation [ Time Frame: 6 months after first injection of ranibizumab. ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 6 months after first injection of ranibizumab. ] [ Designated as safety issue: No ]

    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.


  • Central retinal thickness [ Time Frame: 6 months after first injection of ranibizumab. ] [ Designated as safety issue: No ]

    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.



Enrollment: 24
Study Start Date: October 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with newly diagnosed central retinal vein occlusion who have planned treatment with intravitreal renibizumab

Criteria

Inclusion Criteria:

  1. Central retinal vein occlusion in one eye.
  2. Planned treatment with intravitreal injections of Lucentis (ranibizumab)
  3. Functional fellow eye.

Exclusion Criteria:

  1. 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.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360385

Locations
Denmark
Department of Ophthalmology, Glostrup Hospital
Copenhagen, Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Novartis
Investigators
Principal Investigator: Morten D la Cour, MD, DMsc
  More Information

No publications provided

Responsible Party: Sindri Traustason, Cand. Scient., Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01360385     History of Changes
Other Study ID Numbers: LuRVO
Study First Received: October 28, 2010
Last Updated: September 11, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Glostrup University Hospital, Copenhagen:
Central retinal rein occlusion
Retinal oximetry
Oxymap Retinal Oximeter
Visual acuity
Central retinal thickness

Additional relevant MeSH terms:
Ischemia
Retinal Vein Occlusion
Pathologic Processes
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014