- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01608113
Long-term Follow-up of Subfoveal Neovascular AMD
May 25, 2012 updated by: Christopher Kiss, Medical University of Vienna
Treatment naive patients with subfoveal nAMD initially treated monthly with intravitreal anti-VEGF and subsequently PRN, will be included in this study.
Patients will be investigated for the first 2 years monthly and subsequently according to disease activity but at least every two months.
Patients will be examined with 4m BCVA ETDRS distance visual acuity, reading acuity measured by Radner-Reading-Charts, contrast sensitivity by Pelli-Robson score, microperimetry and HD-OCT.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Vienna, Austria, 1190
- Recruiting
- Department of Ophthalmology Medical University of Vienna
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Sub-Investigator:
- Marion Munk, MD
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Contact:
- Jasmin Mittermüller
- Phone Number: 00431404004847
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Contact:
- Germana Armberger
- Phone Number: 00431404004847
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Sub-Investigator:
- Florian Sulzbacher, MD
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Sub-Investigator:
- Philipp Roberts, MD
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Sub-Investigator:
- Katharina Eibenberger, MD
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients suffering on treatment naive subfoveal neovascular age-related macular degeneration
Description
Inclusion Criteria:
- treatment naive subfoveal AMD, written informed consent, able to read
Exclusion Criteria:
- choroidal neovascularisation due to other ocular diseases, mature cataract
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Long-term visual function performance
Time Frame: four years
|
four years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
change of morphological alterations assessed by SD-OCT
Time Frame: four years
|
four years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher G Kiss, MD, Medical University Vienna
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
September 1, 2011
Study Registration Dates
First Submitted
April 10, 2012
First Submitted That Met QC Criteria
May 25, 2012
First Posted (Estimate)
May 30, 2012
Study Record Updates
Last Update Posted (Estimate)
May 30, 2012
Last Update Submitted That Met QC Criteria
May 25, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK 802/2011
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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