Choroidal Blood Flow and Progression of Age-Related Macular Degeneration in the Fellow Eye in Patients With Unilateral Choroidal Neovascularisation

NCT ID: NCT00808197

Last Updated: 2008-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Brief Summary

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Age-related macular degeneration (AMD) is the chief cause of severe and irreversible loss of vision in developed countries. The prevalence of AMD increases dramatically with age.

The early stage (or dry AMD) is associated with minimal visual impairment and is characterized by large drusen and pigmentary abnormalities in the macula. The late stage is a neovascular, exudative form. This so called exudative AMD includes serous or hemorrhagic detachment of retinal pigment epithelium and choroidal neovascularization leading to severe loss of vision (20/200 or worse). Patients with unilateral CNV (choroidal neovascularisation) have a significant risk of CNV developing in the second eye.

Choroidal blood flow is of great importance for normal visual function. Several reports have provided evidence suggesting that choroidal blood flow is decreased in subjects with AMD. In late stages of AMD angiogenesis leads to the formation of choroidal neovascularization that can cause severe visual impairment by disrupting normal macular function.

The purpose of this evaluation is to investigate a possible link between alterations in choroidal blood flow and the development of CNV and serous detachment in the fellow eye of patients with AMD and unilateral neovascular maculopathy. This longitudinal study may provide important findings with respect to natural history and visual prognosis of patients with neovascularized AMD.

Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry

Detailed Description

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Conditions

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Regional Blood Flow

Keywords

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AMD choroidal blood flow fellow eye in patients with unilateral choroidal neovascularisation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Observatory, longitudinal, 3-years follow up study

Group Type EXPERIMENTAL

ocular blood flow measurement

Intervention Type PROCEDURE

Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry

Interventions

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ocular blood flow measurement

Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male or female patients with unilateral choroidal neovascular AMD and 2-4 risk factors for AMD in the fellow eye.
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Ametropy \< 4 dpt.

Exclusion Criteria

* Abuse of alcoholic beverages
* Participation in a clinical trial in the 3 weeks preceding the study
* Any signs of diabetic retinopathy
* Glaucoma
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Principal Investigators

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Leopold Schmetterer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-140501

Identifier Type: -

Identifier Source: org_study_id