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

Primary Purpose

Regional Blood Flow

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
ocular blood flow measurement
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Regional Blood Flow focused on measuring AMD, choroidal blood flow, fellow eye in patients with unilateral choroidal neovascularisation

Eligibility Criteria

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

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

Sites / Locations

  • Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Observatory, longitudinal, 3-years follow up study

Outcomes

Primary Outcome Measures

Choroidal blood flow (laser Doppler flowmetry)
Fundus pulsation amplitude (laser interferometry)

Secondary Outcome Measures

Full Information

First Posted
December 12, 2008
Last Updated
December 12, 2008
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00808197
Brief Title
Choroidal Blood Flow and Progression of Age-Related Macular Degeneration in the Fellow Eye in Patients With Unilateral Choroidal Neovascularisation
Official Title
Choroidal Blood Flow and Progression of Age-Related Macular Degeneration in the Fellow Eye in Patients With Unilateral Choroidal Neovascularisation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Blood Flow
Keywords
AMD, choroidal blood flow, fellow eye in patients with unilateral choroidal neovascularisation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Observatory, longitudinal, 3-years follow up study
Intervention Type
Procedure
Intervention Name(s)
ocular blood flow measurement
Intervention Description
Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry
Primary Outcome Measure Information:
Title
Choroidal blood flow (laser Doppler flowmetry)
Title
Fundus pulsation amplitude (laser interferometry)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leopold Schmetterer, Prof. Dr.
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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