Long-term Follow-up of Subfoveal Neovascular AMD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Medical University of Vienna.
Recruitment status was  Recruiting
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
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014