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

NCT ID: NCT00709657

Last Updated: 2014-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-11-30

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.

Conditions

Macular Degeneration; Regional Blood Flow; Vascular Endothelial Growth Factor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ranibizumab, bevacizumab or pegaptanib

Intervention Type: DRUG

measurements are performed one week before and after anti-VEGF intravitreal injection

Interventions

ranibizumab, bevacizumab or pegaptanib

measurements are performed one week before and after anti-VEGF intravitreal injection

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gerhard Garhofer

Assoc. Prof. Priv. - Doz. Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerhard Garhöfer, MD

Role: PRINCIPAL_INVESTIGATOR

Depatement of Clinical Pharmacology, Medical University of Vienna

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

OPHT-060707

Identifier Type: -

Identifier Source: org_study_id