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

Bayer163 enrolled

Overview

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.

Data will be collected from the medical files retro- and prospectively. If patients are still under treatment at study initiation and have not yet completed 24 months of treatment with intravitreal aflibercept in a treat-and-extend regimen, data of the remaining observation period will be collected prospectively.

Study Type

OBSERVATIONAL

Enrollment

163

Conditions

Wet Age-related Macular Degeneration

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

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Many Locations

Multiple Locations, Switzerland

Outcomes

Primary Outcomes

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

mean change in ETDRS letters

Time frame: Baseline and at 12 months

Secondary Outcomes

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

mean change in ETDRS letters

Time frame: Baseline and at 24 months

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

Numbers of injections will be predefined as categories and analyzed in relation to the BCVA changes

Time frame: Baseline and at 12 months; Baseline and at 24 months

Mean interval between injections

mean interval displayed in weeks or days

Time frame: At 12 and 24 months

Reasons for the interval length

morphology and / or BCVA /other

Time frame: At 12 and 24 months

Frequency of disease reactivation

Disease activity such as hemorrhage, PED, subretinal fluid, cystoid intraretinal fluid, RPE rip assessed at the investigator's discretion as: none / new or increasing / decreasing / stable

Time frame: Baseline and at 12 months; Baseline and at 24 months

Proportion of eyes gaining or losing ≥ 15 Early Treatment Diabetic Retinopathy Study letters compared to baseline

Proportion evaluated as percentage (%) of eyes

Time frame: Baseline and at 12 months; Baseline and at 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.