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

Not Applicable

Terminated

• Conditions: Regional Blood Flow; Vascular Endothelial Growth Factor; Macular Degeneration
• Interventions: Drug: ranibizumab, bevacizumab or pegaptanib

• Registration Number: NCT00709657
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Primary Completion: 2010-07
• Study Completion: 2011-11
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ranibizumab, bevacizumab or pegaptanib	patients with age-related macular degeneration, which are already scheduled for intravitreal anti-VEGF therapy in one eye are measured before and after treatment.

Primary Outcome Measures

Name	Time	Method
Optic nerve head blood flow	before, one week after and three weeks after intravitreal injection with an anti-VEGF drug

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria