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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00709657
Other study ID # OPHT-060707
Secondary ID
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


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
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