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

Regional Blood Flow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808197
• Other study ID #: OPHT-140501
• Status: Completed
• Phase: N/A
• First received: December 12, 2008
• Last updated: December 12, 2008

Study information

• Verified date: December 2008
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic
• Regional Blood Flow

Intervention

Procedure:
• ocular blood flow measurement
Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choroidal blood flow (laser Doppler flowmetry)
Primary	Fundus pulsation amplitude (laser interferometry)