Observational Study to Assess Intravitreal Aflibercept Injections Used in a "Treat and Extend" Regimen in Treatment-naïve Wet Age-related Macular Degeneration Patients

NCT03382587 | Completed

• 1 other identifier: 18574
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

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

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters)

  mean change in ETDRS letters

  Baseline and at 12 months

Secondary Outcomes (10)

• Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters)

  Baseline and at 24 months

• Mean change in best-corrected visual acuity in relation to the number of injections administered

  Baseline and at 12 months; Baseline and at 24 months

• Mean interval between injections

  At 12 and 24 months

• Reasons for the interval length

  At 12 and 24 months

• Frequency of disease reactivation

  Baseline and at 12 months; Baseline and at 24 months

Study Arms (1)

Aflibercept

Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme

Drug: Aflibercept (Eylea, BAY86-5321)

Interventions

Aflibercept (Eylea, BAY86-5321) DRUG

Intravitreal aflibercept injections used in a routine "treat and extend" regimen, under which the intervals between the injections are extended if disease stability is maintained and no signs of worsening disease are observed on the injection day

Aflibercept

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Many Locations

Multiple Locations, Switzerland

Location

Related Links

• Click here to find results for studies related to Bayer Healthcare products.

MeSH Terms

Interventions

aflibercept

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 26, 2017
• Study Start: December 5, 2017
• Primary Completion: November 9, 2018
• Study Completion: November 27, 2018
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)