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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00709657
Recruitment Status : Terminated
First Posted : July 3, 2008
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Macular Degeneration Regional Blood Flow Vascular Endothelial Growth Factor Drug: ranibizumab, bevacizumab or pegaptanib Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of a Single Intravitreal Anti-VEGF Therapy on Optic Nerve Head Perfusion
Study Start Date : March 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Optic nerve head blood flow [ Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug ]

Secondary Outcome Measures :
  1. Choroidal blood flow [ Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug ]
  2. Retrobulbar blood flow [ Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug ]
  3. Intraocular pressure [ Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug ]
  4. Systemic blood pressure [ Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709657


Locations
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Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Gerhard Garhöfer, MD Depatement of Clinical Pharmacology, Medical University of Vienna
More Information
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Responsible Party: Gerhard Garhofer, Assoc. Prof. Priv. - Doz. Dr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00709657    
Other Study ID Numbers: OPHT-060707
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by Gerhard Garhofer, Medical University of Vienna:
Age-related macular degeneration
anti-VEGF
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Ranibizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors