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NCT01608113 Clinical Trial

Long-term Follow-up of Subfoveal Neovascular AMD

Exudative Age-related Macular Degeneration Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01608113
Other study ID # EK 802/2011
Secondary ID
Status Recruiting
Phase N/A
First received April 10, 2012
Last updated May 25, 2012
Start date September 2011

Study information
Verified date May 2012
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- choroidal neovascularisation due to other ocular diseases, mature cataract

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Department of Ophthalmology Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term visual function performance four years No
Secondary change of morphological alterations assessed by SD-OCT four years No
See also
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