Status:
COMPLETED
Observational Study to Assess Intravitreal Aflibercept Injections Used in a "Treat and Extend" Regimen in Treatment-naïve Wet Age-related Macular Degeneration Patients
Lead Sponsor:
Bayer
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Wet Age-related Macular Degeneration
Eligibility:
All Genders
55+ years
Brief Summary
The purpose of this observational study lies in the analysis of a treat-and-extend injection scheme with intravitreal aflibercept (i.e. injection into the eye), as applied in routine practice in previ...
Detailed Description
Data will be collected from the medical files retro- and prospectively. If patients are still under treatment at study initiation and have not yet completed 24 months of treatment with intravitreal af...
Eligibility Criteria
Inclusion
- Diagnosis of wet age-related macular degeneration.
- No prior therapy for wet age-related macular degeneration.
- Patients for whom the decision to initiate treatment with IVT-AFL in a T\&E regimen was made as per routine clinical practice.
- Patient age \>55 years of age
Exclusion
- Participation in an investigational program with therapeutical interventions outside of clinical routine practice.
- Patients with eye diseases e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye.
- Concomitant ocular or systemic administration of drugs up to 3 months before commencement of IVT-AFL treatment that could interfere with or potentiate the mechanism of action of aflibercept, including anti-VEGF agents. This includes patients receiving a different anti-VEGF agent for the fellow eye
Key Trial Info
Start Date :
December 5 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 27 2018
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT03382587
Start Date
December 5 2017
End Date
November 27 2018
Last Update
June 5 2023
Active Locations (1)
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1
Many Locations
Multiple Locations, Switzerland