Clinical trial NCT03382587: Observational Study to Assess Intravitreal Aflibercept Injections Used in a "Treat and Extend" Regimen in Treatment-naïve Wet Age-related Macular Degeneration Patients
Official title: An Observational Study to Assess the Use of Intravitreal Aflibercept Injections in a Routine "Treat and Extend" Regimen in Treatment-naïve Patients Diagnosed With Wet Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet Age-related Macular Degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2017-12-26
Enrollment: 163
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters)
timeFrame: Baseline and at 12 months
Secondary outcomes:
measure: Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters)
timeFrame: Baseline and at 24 months
measure: Mean change in best-corrected visual acuity in relation to the number of injections administered
timeFrame: Baseline and at 12 months; Baseline and at 24 months
measure: Mean interval between injections
timeFrame: At 12 and 24 months
measure: Reasons for the interval length
timeFrame: At 12 and 24 months
measure: Frequency of disease reactivation
timeFrame: Baseline and at 12 months; Baseline and at 24 months
measure: Proportion of eyes gaining or losing ≥ 15 Early Treatment Diabetic Retinopathy Study letters compared to baseline
timeFrame: Baseline and at 12 months; Baseline and at 24 months
measure: Mean changes from baseline in central retinal thickness (CRT)
timeFrame: Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months
measure: Changes from baseline in retinal fluid
timeFrame: Baseline and at 12 months; Baseline and at 24 months
measure: Reasons for termination of therapy (including subsequent therapy at time of discontinuation)
timeFrame: At 12 and 24 months
measure: Severity of disease reactivation
timeFrame: Baseline and at 12 months; Baseline and at 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Switzerland
facility: Many Locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: