The Effect of a Single Intravitreal Anti-VEGF Therapy on Optic Nerve Head Perfusion

November 13, 2014 updated by: Gerhard Garhofer, Medical University of Vienna

Age related macula degeneration is one of the most common sight threatening diseases of the elderly. The so called wet form of AMD is caused by choroidal neovascularisation (CNV) of pathological vessels, which lead to leakage, bleeding and macular edema. Several lines of evidence suggest that vascular endothelial growth factor (VEGF) plays a key role in the induction CNV. Recent evidence indicates that overexpression of VEGF in the retinal pigment epithelium may lead to the development of CNV in experimental models, and intravitreal injection of a VEGF blocker prevents the development of experimental CNV. This hypothesis is also supported by the promising effects of anti-VEGF treatment in patients with choroidal neovascularisation. The substances currently in clinical use include ranibizumab (Lucentis®), bevacizumab (Avastin®) and pegaptanib (Macugen®).

However, from a physiological point of view, VEGF also serves as a survival factor for existing vessels and for neuronal cells. Moreover, it has been reported that VEGF induces vasodilatation, most probably by an increased production of nitric oxide. Accordingly one may hypothesize that anti-VEGF treatment is associated with ocular vasoconstriction with unknown long term results. Thus, in the current study, the investigators set out to investigate whether the ocular perfusion is affected by a single intravitreal anti-VEGF.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

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
        • Department of Clinical Pharmacology, Medical University of Vienna

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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40 subjects ≥ 50 years of age
  • Subjects with all angiographic subtypes of neovascular wet AMD, already scheduled for intravitreal anti-VEGF therapy in one eye
  • Good central or eccentric fixation

Exclusion Criteria:

  • History or previous Anti-VEGF therapy
  • History or previous intravitreal injection with any drug
  • Intraocular pressure ≥ 25
  • Glaucoma
  • History or presence of thromboembolic events
  • Diabetes mellitus
  • Blood donation during the previous 3 weeks
  • Ametropy ≥ 6 dpt

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: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
patients with age-related macular degeneration, which are already scheduled for intravitreal anti-VEGF therapy in one eye are measured before and after treatment.
Drug: ranibizumab, bevacizumab or pegaptanib
measurements are performed one week before and after anti-VEGF intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optic nerve head blood flow
Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
before, one week after and three weeks after intravitreal injection with an anti-VEGF drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Choroidal blood flow
Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
Retrobulbar blood flow
Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
Intraocular pressure
Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
Systemic blood pressure
Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
before, one week after and three weeks after intravitreal injection with an anti-VEGF drug

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Gerhard Garhöfer, MD, Depatement of Clinical Pharmacology, Medical University of Vienna

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

March 1, 2008

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (ESTIMATE)

July 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHT-060707

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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