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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00808197
First received: December 12, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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


Condition Intervention
Regional Blood Flow
 Procedure: ocular blood flow measurement

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Choroidal Blood Flow and Progression of Age-Related Macular Degeneration in the Fellow Eye in Patients With Unilateral Choroidal Neovascularisation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Choroidal blood flow (laser Doppler flowmetry)
  • Fundus pulsation amplitude (laser interferometry)

Estimated Enrollment: 41
Arms Assigned Interventions
Experimental: 1
Observatory, longitudinal, 3-years follow up study
 Procedure: ocular blood flow measurement
Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808197

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Leopold Schmetterer, Prof. Dr. Department of Clinical Pharmacology, Medical University of Vienna
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00808197     History of Changes
Other Study ID Numbers: OPHT-140501
Study First Received: December 12, 2008
Last Updated: December 12, 2008
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
AMD
choroidal blood flow
fellow eye in patients with unilateral choroidal neovascularisation

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on May 19, 2013