Clinical trial NCT03939767: Assessment of Proactive Treatments in Patients With Wet Age-related Macular Degeneration (wAMD) Which Have Never Undergone Treatment of This Particular Disease
Official title: Evaluation of an eXtended and proacTive Dosing regimEn in Treatment-Naïve Patients With Wet Age-related Macular Degeneration (wAMD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet Age-related Macular Degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-05-07
Enrollment: 1563
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 2.000 patients from sites in Asia-Pacific, Europe, Latin America and North America.

Brief summary: In this observational study researchers want to learn more about changes in visual acuity (clarity of vision) with proactive flexible treatments over time in patients suffering from wet age-related macular degeneration (wAMD) after decision to treat with Aflibercept (Eylea) was made. Wet AMD is an eye disease that progressively destroys the macula, the central portion of the retina, impairing central vision.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of wAMD.
* Patients for whom the decision to initiate treatment with IVT aflibercept in a proactive regimen was made as routine clinical practice.
* Treatment-naïve in the study eye (no prior therapy for wAMD).
* Patient age ≥50 years of age.
* Written informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).

Exclusion Criteria:

* Participation in an investigational program with interventions outside of routine clinical practice.
* Patients with contraindications to IVT aflibercept listed in the local marketing authorization.
* Planned treatment regimen outside of the local marketing authorization.
* 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 IVT aflibercept treatment that could interfere with or potentiate the mechanism of action of IVT aflibercept, including other anti-VEGF agents in the fellow eye.
* Any other retinal disease which may interfere with the treatment of wAMD.

Primary outcomes:
measure: The change in BCVA (best corrected visual acuity)
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: The change in BCVA
timeFrame: Baseline to 24 and 36 months
measure: The change in BCVA by intended treatment regimen
timeFrame: Baseline to 12, 24 and 36 months
measure: The proportion of patients (eyes) gaining or losing a visual acuity compared to baseline
timeFrame: Baseline at 12, 24 and 36 months
measure: The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better (approximately 73 ETDRS letters)
timeFrame: At 12, 24 and 36 months
measure: The changes in central retinal thickness (CRT)
timeFrame: Baseline to 12, 24 and 36 months
measure: The number of injections
timeFrame: Baseline to 12, 24 and 36 months
measure: The distribution of the intervals between injections
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Multiple Locations
country: Argentina
facility: Many Locations
city: Multiple Locations
country: Australia
facility: Many Locations
city: Multiple Locations
country: Belgium
facility: Many Locations
city: Multiple Locations
country: Canada
facility: Many Locations
city: Multiple Locations
country: China
facility: Many Locations
city: Multiple Locations
country: Colombia
facility: Many Locations
city: Multiple Locations
country: Denmark
facility: Many Locations
city: Multiple Locations
country: France
facility: Many Locations
city: Multiple Locations
country: Ireland
facility: Many Locations
city: Multiple Locations
country: Italy
facility: Many Locations
city: Multiple Locations
country: Korea, Republic of
facility: Many Locations
city: Multiple Locations
country: Norway
facility: Many Locations
city: Multiple Locations
country: Spain
facility: Many Locations
city: Multiple Locations
country: Sweden
facility: Many Locations
city: Multiple Locations
country: Switzerland
facility: Many Locations
city: Multiple Locations
country: Thailand
facility: Many Locations
city: Multiple Locations
country: United Kingdom
facility: Many Locations
Study officials:
References: