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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00709657
• Other study ID #: OPHT-060707
• Status: Terminated
• Phase: N/A
• First received: July 1, 2008
• Last updated: November 13, 2014
• Start date: March 2008
• Est. completion date: November 2011

Study information

• Verified date: November 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Macular Degeneration
• Regional Blood Flow
• Vascular Endothelial Growth Factor

Intervention

Drug:
• ranibizumab, bevacizumab or pegaptanib
measurements are performed one week before and after anti-VEGF intravitreal injection

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optic nerve head blood flow		before, one week after and three weeks after intravitreal injection with an anti-VEGF drug	No
Secondary	Choroidal blood flow		before, one week after and three weeks after intravitreal injection with an anti-VEGF drug	No
Secondary	Retrobulbar blood flow		before, one week after and three weeks after intravitreal injection with an anti-VEGF drug	No
Secondary	Intraocular pressure		before, one week after and three weeks after intravitreal injection with an anti-VEGF drug	No
Secondary	Systemic blood pressure		before, one week after and three weeks after intravitreal injection with an anti-VEGF drug	No