NCT01360385

Brief 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 . 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 12, 2012

Status Verified

September 1, 2012

Enrollment Period

1.8 years

First QC Date

October 28, 2010

Last Update Submit

September 11, 2012

Conditions

Central Retinal Vein Occlusion

Keywords

Central retinal rein occlusionRetinal oximetryOxymap Retinal OximeterVisual acuityCentral retinal thickness

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months after first injection of ranibizumab.

Secondary Outcomes (2)

  • Visual acuity

    6 months after first injection of ranibizumab.

  • Central retinal thickness

    6 months after first injection of ranibizumab.

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Glostrup Hospital

Copenhagen, Glostrup, 2600, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 24729079DERIVED

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Morten D la Cour, MD, DMsc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cand. Scient.

Study Record Dates

First Submitted

October 28, 2010

First Posted

May 25, 2011

Study Start

October 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 12, 2012

Record last verified: 2012-09

Locations

DK(1)