Non-Persistence/Non-Adherence (NP/NA) in Wet Age-related Macular Degeneration (wAMD) Patients in Germany

Bayer

Status: Completed

Conditions: Wet Macular Degeneration

Treatments: Drug: Anti-VEGF injections

Study type: Observational

Funder types: Industry

Identifiers

NCT01448538

15785

HE-WAMD-01 (Other Identifier)

Details and patient eligibility

About

In the research study an observation of patients with wet age-related macular degeneration (wet AMD) will be performed.

The term observational study indicates that the current course of therapy and the associated circumstances will be recorded. In this study, no medical care is changed. Also, no new drugs are tested.

This study is being conducted in about 30 centers in Germany. A total of approximately 500 patients will be enrolled. The study is designed for a period of 12 months.

At the beginning and end of the study the physician will document the patient data. Therefore will be used information from the patient records and documented visits. If such information is not available in the study center, the otherwise attending ophthalmologist will be consulted about the vision acuity values and visits in the observation period.

Furthermore, patients are asked to participate in three telephone interviews and fill out during their visits to the study center a short questionnaire about their current vision and their well-being. In the telephone interviews will be discussed with the patient about his wet AMD disease and its treatment, its experience and its perspectives as well as any problems occur.

Enrollment: 480 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has wet age-related macular degeneration (wAMD)
• Patient has already received at least one Anti-VEGF injection
• From a clinical standpoint, if there is an ophthalmological need for treatment it is probable that the patient gets additional anti-VEGF injections in the next year.
• The patient is able and willing to take part in the study (answering a short questionnaire in the study centre, 4 independent phone interviews during study period).

Exclusion criteria

• At time of inclusion visit, the study centre is only exceptionally responsible for the treatment of the patient.
• The patient is taking part in another study.

Trial design

480 participants in 1 patient group

Group 1

Treatment:

Drug: Anti-VEGF injections