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

Primary Purpose

Macular Degeneration, Regional Blood Flow, Vascular Endothelial Growth Factor

Status

Terminated

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

ranibizumab, bevacizumab or pegaptanib

About this trial

This is an interventional basic science trial for Macular Degeneration focused on measuring Age-related macular degeneration, anti-VEGF

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

patients with age-related macular degeneration, which are already scheduled for intravitreal anti-VEGF therapy in one eye are measured before and after treatment.

Outcomes

Primary Outcome Measures

Optic nerve head blood flow

Secondary Outcome Measures

Choroidal blood flow

Retrobulbar blood flow

Intraocular pressure

Systemic blood pressure

Full Information

NCT ID

NCT00709657

First Posted

July 1, 2008

Last Updated

November 13, 2014

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00709657

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Terminated

Study Start Date

March 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Degeneration, Regional Blood Flow, Vascular Endothelial Growth Factor

Keywords

Age-related macular degeneration, anti-VEGF

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

patients with age-related macular degeneration, which are already scheduled for intravitreal anti-VEGF therapy in one eye are measured before and after treatment.

Intervention Type

Drug

Intervention Name(s)

ranibizumab, bevacizumab or pegaptanib

Intervention Description

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

Primary Outcome Measure Information:

Title

Optic nerve head blood flow

Time Frame