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

Purpose

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, we set out to investigate whether the ocular perfusion is affected by a single intravitreal anti-VEGF.

Condition	Intervention
Macular Degeneration Regional Blood Flow Vascular Endothelial Growth Factors	Drug: ranibizumab, bevacizumab or pegaptanib

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Macular Degeneration

Drug Information available for:

Bevacizumab Ranibizumab Pegaptanib sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Optic nerve head blood flow [ Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Choroidal blood flow [ Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug ] [ Designated as safety issue: No ]
Retrobulbar blood flow [ Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug ] [ Designated as safety issue: No ]
Intraocular pressure [ Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug ] [ Designated as safety issue: No ]
Systemic blood pressure [ Time Frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709657

Contacts


Contact: Gerhard Garhöfer, MD	43-14-0400 ext 2981	gerhard.garhoefer@meduniwien.ac.at

Locations


Austria
	Department of Clinical Pharmacology, Medical University of Vienna	Recruiting
	Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators


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

More Information

Responsible Party:	Department of Clinical Pharmacology, Medical University of Vienna ( Gerhard Garhöfer, MD )
Study ID Numbers:	OPHT-060707
First Received:	July 1, 2008
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00709657
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:

Age-related macular degeneration

anti-VEGF

Study placed in the following topic categories:

Eye Diseases

Retinal Degeneration

Macular Degeneration

Bevacizumab

Retinal Diseases

Retinal degeneration

Additional relevant MeSH terms:

Antineoplastic Agents

Therapeutic Uses

Growth Substances

Physiological Effects of Drugs

Growth Inhibitors

Angiogenesis Modulating Agents

Angiogenesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 04, 2008

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00709657