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.

NCT03714308 | Completed

• 1 other identifier: 19756
• Study Type: observational
• Target: 554
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Macular Degeneration

Keywords

Neovascular age-related macular degeneration

Outcome Measures

Primary Outcomes (2)

• Time to first appearance of non-consistence

  Non-consistence is: * Failure of subjects to appear to a scheduled injection visit; * Strong time deviation of injections from approved aflibercept posology.

  Up to 24 months

• Reasons why a patient failed to appear to a scheduled injection visit

  Asked in telephone interviews

  Up to 24 months

Secondary Outcomes (27)

• Change in best corrected visual acuity (BCVA) letters

  From baseline to 4, 12 and 24 months

• Change in central retinal thickness (CRT)

  From baseline to 4, 12 and 24 months

• Treatment satisfaction by MAC-TSQ

  At 4, 12 and 24 months

• Change in treatment satisfaction

  From 4 month to 12 and 24 months

• Vision-specific quality of life by NEI VFQ-25

  At baseline, 4, 12 and 24 months

Study Arms (3)

Patients with nAMD_Treatment-naive (anti-VEGF naive)

Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months

Drug: Ivt. Aflibercept (Eylea, BAY86-5321)

Patients with nAMD_Pre-treated with IVT-AFL

Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months

Drug: Ivt. Aflibercept (Eylea, BAY86-5321)

Patients with nAMD_Pre-treated with any anti-VEGF

Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months

Drug: Ivt. Aflibercept (Eylea, BAY86-5321)

Interventions

Ivt. Aflibercept (Eylea, BAY86-5321) DRUG

Treatment is applied according to routine clinical practice and independent of the study setting.

Patients with nAMD_Pre-treated with IVT-AFL; Patients with nAMD_Pre-treated with any anti-VEGF; Patients with nAMD_Treatment-naive (anti-VEGF naive)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with neovascular age-related macular degeneration (nAMD)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Germany

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 22, 2018
• Study Start: January 28, 2019
• Primary Completion: March 6, 2023
• Study Completion: May 12, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)