Trial Condition(s):

Macular degeneration

Aflibercept injection into the vitreous body of the eye: Study to learn more about patient relevant outcomes, real world treatment patterns and how well the treatment works for patients suffering from abnormal growth of new blood vessels under the retina. (ANDROMEDA)

Bayer Identifier:

19756

ClinicalTrials.gov Identifier:

NCT03714308

EudraCT Number:

Not Available

Recruitment Complete

Trial Purpose

In this clinical study researchers want to gain a deeper understanding of treatment consistence under real world conditions over the course of 24 months of Aflibercept injections into the eye for patients suffering from abnormal growth of new blood vessels under the retina (neovascular age-related macular degeneration). The study aims to identify potential reasons that may allow classification of non-consistence as patient or physician driven. They want to describe treatment effectiveness (how well the treatment works) and associations between treatment effectiveness, non-consistence and patient relevant outcomes, such as vision specific quality of life and treatment satisfaction.

Inclusion Criteria
- Diagnosis of neovascular age-related macular degeneration
 - Decision to initiate treatment with intravitreal aflibercept was made as per investigator’s routine treatment practice or current treatment with IVT-AFL (all prior anti-VEGF treatments must have been applied by the participating study site)
 - No participation in an investigational program with interventions outside of routine clinical practice
 - No contra-indications according to the local marketing authorization/ Summary of Product Characteristics (SmPC)
 - Ability and willingness to participate in telephone interviews
Exclusion Criteria
- Any prior therapy with intravitreal steroids in the study eye.
 - Concomitant therapy (except nutritional supplements) with any other agent to treat nAMD in the study eye
 - Any prior transpupillary thermotherapy, photodynamic therapy, macular rotation/ translocation or macular laser in the study eye or
 - Structural damage to the center of the macula in either eye
 - Any other condition expected to permanently limit visual acuity outcomes over the course of the study

Trial Summary

Enrollment Goal
1000
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Germany

Status
Recruiting
 

Trial Design