- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00926861
Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative Age Related Macular Degeneration (AMD) to Develop Exudative AMD (PAM)
June 8, 2010 updated by: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative AMD to Develop Exudative AMD
Choroidal neovascularisation in age related macular degeneration is one of the major causes of legal blindness in the western world existing in two major occurences, the dry and the wet form.The etiology of age related macular degeneration is yet unknown.
Genetic factors, oxidative stress, Ischaemia, and aging of the retinal pigment epithelium are discussed as etiologic factors.
The risk of rapid vision loss is much higher in wet AMD, a dry form may transform to a wet form.
From a prior study the investigators know that the posterior hyaloid is significantly more frequent attached in wet AMD.
This study is conducted to examine whether the attached posterior hyaloid is a risk factor to develop wet AMD in dry AMD cases.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
320
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ilse Krebs, MD
- Phone Number: 4607 +43171165
- Email: ilse.krebs@wienkav.at
Study Locations
-
-
-
Vienna, Austria, 1030
- Recruiting
- Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
-
Contact:
- Ilse Krebs, MD
- Phone Number: 94682 43-17-1165
- Email: Ilse.Krebs@wienkav.at
-
Sub-Investigator:
- Ilse Krebs, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
male or female persons aged over 50 years with dry AMD
Description
Inclusion Criteria:
- Dry MD
- Age over 50 years
Exclusion Criteria:
- Macular pathologies other than age related macular degeneration (like diabetic maculopathy, macular pucker, macular hole)
- Prior vitrectomy or buckle surgery
- Uveitis posterior, multifocal chorioiditis
- Pathologic myopia
- Diabetic retinopathy
- Visualization of the macula not possible (dens cataract, vitreous haemorrhage)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Dry AMD
male or female persons aged over 50 years with dry age-related macular degeneration
|
A-scan and B-scan ultrasound at baseline and month 6,12,24
Volume scans of spectralis OCT at baseline and month 6,12,24
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of eyes with non-exudative AMD with attached and detached posterior vitreous cortex developing exudative AMD
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Distance acuity
Time Frame: 24 months
|
24 months
|
Age
Time Frame: 24 months
|
24 months
|
Smoking
Time Frame: 24 months
|
24 months
|
Obesity
Time Frame: 24 months
|
24 months
|
Lesion classification (AREDS)
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Susanne Binder, Prof MD, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
June 23, 2009
First Submitted That Met QC Criteria
June 23, 2009
First Posted (Estimate)
June 24, 2009
Study Record Updates
Last Update Posted (Estimate)
June 9, 2010
Last Update Submitted That Met QC Criteria
June 8, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-052-0409
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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