Trial Condition(s):

Wet age-related macular degeneration

Observational study to assess intravitreal aflibercept injections used in a “treat and extend” regimen in treatment-naïve wet age-related macular degeneration patients (ASTERIA)

Bayer Identifier:

18574

ClinicalTrials.gov Identifier:

NCT03382587

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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 previously untreated patients diagnosed with wet age-related macular degeneration.

Inclusion Criteria
- 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 Criteria
- 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

Trial Summary

Enrollment Goal
163
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Switzerland

Status
Recruiting
 

Trial Design