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Long-term Follow-up of Subfoveal Neovascular AMD

This study is currently recruiting participants.
Verified May 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Christopher Kiss, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01608113
First received: April 10, 2012
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Long-term visual function performance [ Time Frame: four years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change of morphological alterations assessed by SD-OCT [ Time Frame: four years ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2011
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 10, 2012
Last Updated: May 25, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by 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

ClinicalTrials.gov processed this record on June 17, 2013