Clinical trial NCT00808197: 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
Overall status: COMPLETED
Phase: NA
Conditions: Regional Blood Flow
Keywords: AMD
choroidal blood flow
fellow eye in patients with unilateral choroidal neovascularisation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-12-15
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Choroidal blood flow (laser Doppler flowmetry)
measure: Fundus pulsation amplitude (laser interferometry)
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Leopold Schmetterer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: