Ranibizumab in Patients With Branch Retinal Vein Occlusion

December 7, 2009 updated by: Medical University of Vienna

Response of Retinal Vessels to Anti Vascular Endothelial Growth Factor (VEGF) Treatment in Patients With Branch Retinal Vein Occlusion (BRVO)

In a recent study we could show that the early retinal venous vasoconstriction after grid photocoagulation in branch retinal vein occlusion (BRVO) is closely correlated to the visual outcome after three months. This could be of clinical importance, because the degree of vasoconstriction might be an early marker of treatment success, compatible with the idea that hypoxia is the major trigger of VEGF in BRVO. The present study evaluates the response of retinal vessel diameters to anti VEGF treatment with lucentis in patients with BRVO. This is done in an effort to gain insight into the retinal hemodynamic consequences of anti VEGF treatment in BRVO. The hypothesis that anti VEGF treatment is associated with a vasoconstrictor response in retinal vessel in patients with BRVO is tested.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To investigate the response of retinal vessel diameters to lucentis treatment in patients with BRVO and to correlate these changes with changes in functional outcome after 3 months.

Pilot study in patients scheduled for intravitreal anti-VEGF (Lucentis™) treatment with BRVO

30 patients with BRVO scheduled for intravitreal anti-VEGF treatment Intravitreous administration of Ranibizumab (Lucentis ™)

Main outcome measure: Retinal vessel diameters

Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity assessed with Microperimetry, objective functional response assessed with mfERG, anatomic changes in the macula region as assessed with StratusOCT and prototype of a Cirrus-OCT(which is available at the Department of Ophthalmology, Medical University of Vienna), angiographical outcomes.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Vienna General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female, at least 18 years of age.
  • ophthalmoscopic evidence of recent BRVO, that is, a history of 3 months.
  • macular edema secondary to BRVO in the study eye scheduled for intravittreal anti-VEGF as primary treatment.
  • retinal thickness of > 300 µm by OCT in the central subfield of the study eye at baseline.
  • VA decrease attributable to the edema.
  • written informed consent has been obtained.
  • female patients of childbearing potential must have a negative urine pregnancy test.

Exclusion Criteria:

  • Uncontrolled sytemic disease
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Any ocular condition that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (eg severe macular ischemia)
  • History of glaucoma, aphakie or presence of anterior chamber intraocular lens, active reinal neovascularisation, choroidal neovascularisation, significant cataract, presence of rubeosis iridis, any ocular infection, history of pars plana vitrectomy, anticipated need for ocular surgery in the study eye during the study perios.
  • contraindication to pupil dilation known allergy or contraindication to the use of fluorescein.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Main outcome measure: Retinal vessel diameters
Time Frame: weeks 1, 4 and 16
weeks 1, 4 and 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity, objective functional response, anatomic changes in the macula region, angiographical outcomes.
Time Frame: weeks 1,4 and16
weeks 1,4 and16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Stefan Sacu, Ass. Prof., Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 7, 2009

First Posted (Estimate)

December 8, 2009

Study Record Updates

Last Update Posted (Estimate)

December 8, 2009

Last Update Submitted That Met QC Criteria

December 7, 2009

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1

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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