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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03939767
Other study ID # 20359
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 12, 2019
Est. completion date October 17, 2023

Study information

Verified date October 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1563
Est. completion date October 17, 2023
Est. primary completion date July 7, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Aflibercept (Eylea, BAY86-5321)
As prescribed by the treating physician according to the local label. No IVT aflibercept will be provided due to a nature of observational study.

Locations

Country Name City State
Argentina Many Locations Multiple Locations
Australia Many Locations Multiple Locations
Belgium Many Locations Multiple Locations
Canada Many Locations Multiple Locations
China Many Locations Multiple Locations
Colombia Many Locations Multiple Locations
Denmark Many Locations Multiple Locations
France Many Locations Multiple Locations
Ireland Many Locations Multiple Locations
Italy Many Locations Multiple Locations
Korea, Republic of Many Locations Multiple Locations
Norway Many Locations Multiple Locations
Spain Many Locations Multiple Locations
Sweden Many Locations Multiple Locations
Switzerland Many Locations Multiple Locations
Thailand Many Locations Multiple Locations
United Kingdom Many Locations Multiple Locations

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Canada,  China,  Colombia,  Denmark,  France,  Ireland,  Italy,  Korea, Republic of,  Norway,  Spain,  Sweden,  Switzerland,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The change in BCVA (best corrected visual acuity) In treatment-naïve wAMD patients treated with IVT aflibercept in a flexible proactive treatment pattern (fixed dosing or T&E (Treat and Extend Regimen)) by label regimen. Baseline to 12 months
Secondary The change in BCVA Baseline to 24 and 36 months
Secondary The change in BCVA by intended treatment regimen Baseline to 12, 24 and 36 months
Secondary The proportion of patients (eyes) gaining or losing a visual acuity compared to baseline With letter score of = 0 letters, =5 letters, = 10 letters, = 15 letters. Baseline at 12, 24 and 36 months
Secondary The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better At 12, 24 and 36 months
Secondary The changes in central retinal thickness (CRT) Baseline to 12, 24 and 36 months
Secondary The number of injections Baseline to 12, 24 and 36 months
Secondary The distribution of the intervals between injections Up to 36 months
See also
  Status Clinical Trial Phase
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Terminated NCT04594681 - A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration Phase 1
Completed NCT03585556 - AAVCAGsCD59 for the Treatment of Wet AMD Phase 1
Completed NCT03362190 - ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD) Phase 2
Not yet recruiting NCT04564937 - The Study of Drug SCT510A in Patients With Wet Age-related Macular Degeneration (wAMD) Phase 1/Phase 2
Recruiting NCT04504123 - MMP-9 Inhibition for Recalcitrant Wet AMD Phase 2
Terminated NCT02005133 - A Prospective, Observational, Multicentre, 2 Year Study Evaluating the Use of Eylea (Aflibercept) for the Treatment of Neovascular (Wet) Age-related Macular Degeneration in UK NHS Opthalmology Clinics N/A
Completed NCT01016873 - INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD Phase 2
Completed NCT03748784 - ADVM-022 Intravitreal Gene Therapy for Wet AMD Phase 1
Recruiting NCT04468997 - The Study of Drug 601 in Patients With Wet Age-related Macular Degeneration (wAMD) Phase 1
Completed NCT04685369 - Effectiveness of Anti-VEGF Treatments in Wet AMD in Active Smokers
Enrolling by invitation NCT04932980 - Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD N/A
Recruiting NCT05297292 - A Study to Evaluate the Efficacy and Safety of MW02 in the Treatment of nAMD Phase 2/Phase 3
Completed NCT03066258 - Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial Phase 1/Phase 2
Terminated NCT01086761 - Study of MP0112 Intravitreal Injection in Patients With Wet Age Related Macular Degeneration Phase 1
Recruiting NCT05727397 - Efficacy and Safety of RC28-E Versus Aflibercept Phase 3
Completed NCT04884399 - Phase I Study to Compare CMAB818 Injection and Lucentis® in Patients With Wet AMD Phase 1
Completed NCT04964089 - A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) Phase 3
Withdrawn NCT01339949 - Study to Evaluate the Safety and Effectiveness of IRay in Wet Age-related Macular Degeneration (AMD) Patients With Recurrent Leakage Secondary to Choroidal Neovascularisation (CNV) N/A
Terminated NCT00139282 - A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration Phase 3