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

NCT00808197 | Completed

• 1 other identifier: OPHT-140501
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Conditions

Regional Blood Flow

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Choroidal blood flow (laser Doppler flowmetry)

• Fundus pulsation amplitude (laser interferometry)

Study Arms (1)

1

EXPERIMENTAL

Observatory, longitudinal, 3-years follow up study

Procedure: ocular blood flow measurement

Interventions

ocular blood flow measurement PROCEDURE

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

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Location

Study Officials

• Leopold Schmetterer, Prof. Dr.

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Last Updated: December 15, 2008

Record last verified: 2008-12

Locations

AU (1)