Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In people with neovascular age-related macular degeneration (nAMD), the body makes too much of a protein called vascular endothelial growth factor (VEGF). This causes too many blood vessels to grow in a part of the eye called the macula. These blood vessels can damage the macula, causing dark spots and blurriness in central vision.
The study drug, aflibercept, works by reducing VEGF levels in the eye.It has already been approved for patients to receive as a treatment for nAMD in a fixed 8-weekly or treat-and-extend dosing regimen after having received 3 monthly doses at the start of treatment. In this study, the researchers want to learn more about how often patients received aflibercept and how their vision changed.
The study will include patients with nAMD who had not received treatment to reduce VEGF levels in the eye before. These patients will have started treatment with aflibercept between January 2016 and November 2018. The study will include about 330 men and women who are at least 18 years old.
All of the patients had received aflibercept eye injections based on their doctor's instructions. The researchers will use the patients' medical records from January 2016 to November 2020 to measure the following:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Adult Belgian patients diagnosed with neovascular age-related macular degeneration (nAMD) with treatment-naïve study eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | As prescribed by the treating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of injections in the first 24 months of treatment | Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020) | |
| Last injection interval in the 2nd year of treatment | Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of aflibercept injections during the 1st, 3rd and 4th year of treatment | Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 | |
| Last injection interval in the 1st, 3rd and 4th year | Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients to be enrolled into the study must have been diagnosed with neovascular age-related macular degeneration (nAMD) and started anti-VEGF treatment with aflibercept.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Belgium |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Most stable interval between aflibercept injections in the 2nd, 3rd and 4th year | Definition of 'most stable injection interval according to the ophthalmologist | Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 |
| Number of monitoring visits during each year of the study | Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 |
| Change in best corrected visual acuity (BCVA) from baseline to 90 days and after each year in the study | BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS. | Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 |
| Central retinal thickness (in μm) measured by Optical coherence tomography (OCT) | Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT). | Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 |
| Number of patients with presence of fluid or anatomical parameters (IRF/SRF/PED) | IRF:Intra-Retinal Fluid/ SRF: Sub-Retinal Fluid / PED:Pigment Epithelial Detachment | Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 |
| Number of patients with absence of fluid or anatomical parameters (IRF/SRF/PED) | Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 |
| Reason for discontinuation of aflibercept treatment after 24 months | Reasons : Adverse event, lack of efficacy, remission and stop monitoring, remission and start monitor-and-extend, reimbursement issues, patients' decision, unknown | Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 |
| Number of patients discontinuing aflibercept treatment within the first 24 months | Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 |
| Reason for discontinuation of aflibercept treatment during first 24 months | Reasons :Adverse event, lack of efficacy, remission and stop monitoring, remission and start monitor-and-extend, reimbursement issues, patients' decision, unknown | Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 |
| Number of patients discontinuing aflibercept treatment after 24 months | Retrospective analysis from 01-Jan-2016 to 30-Nov-2020 |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided