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Long-term Follow-up of Subfoveal Neovascular AMD

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Christopher Kiss, Medical University of Vienna.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608113
First Posted: May 30, 2012
Last Update Posted: May 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christopher Kiss, Medical University of Vienna
  Purpose
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.

Condition
Exudative Age-related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Christopher Kiss, Medical University of Vienna:

Primary Outcome Measures:
  • Long-term visual function performance [ Time Frame: four years ]

Secondary Outcome Measures:
  • change of morphological alterations assessed by SD-OCT [ Time Frame: four years ]

Estimated Enrollment: 70
Study Start Date: September 2011
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering on treatment naive subfoveal neovascular age-related macular degeneration
Criteria

Inclusion Criteria:

  • treatment naive subfoveal AMD, written informed consent, able to read

Exclusion Criteria:

  • choroidal neovascularisation due to other ocular diseases, mature cataract
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608113


Locations
Austria
Department of Ophthalmology Medical University of Vienna Recruiting
Vienna, Austria, 1190
Contact: Jasmin Mittermüller    00431404004847      
Contact: Germana Armberger    00431404004847      
Sub-Investigator: Florian Sulzbacher, MD         
Sub-Investigator: Marion Munk, MD         
Sub-Investigator: Philipp Roberts, MD         
Sub-Investigator: Katharina Eibenberger, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Christopher G Kiss, MD Medical University Vienna
  More Information

Responsible Party: Christopher Kiss, Head of Vienna Study Center, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01608113     History of Changes
Other Study ID Numbers: EK 802/2011
First Submitted: April 10, 2012
First Posted: May 30, 2012
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by Christopher Kiss, Medical University of Vienna:
neovascular AMD
Optical coherence tomography
reading acuity
contrast sensitivity

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases