Many Locations
Multiple Locations, Belgium
NCT Number: NCT04641234
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:
* the number of aflibercept eye injections the patients received * how long the patients could wait between treatments * the change in the patients' vision * how many patients stopped treatment and why. * associations between patient and disease characteristics at the start of treatment with the number of aflibercept injections and patient's vision during treatment.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Multiple Locations, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
As prescribed by the treating physician
Time frame: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)
Time frame: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Definition of 'most stable injection interval according to the ophthalmologist
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT).
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
IRF:Intra-Retinal Fluid/ SRF: Sub-Retinal Fluid / PED:Pigment Epithelial Detachment
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Reasons : Adverse event, lack of efficacy, remission and stop monitoring, remission and start monitor-and-extend, reimbursement issues, patients' decision, unknown
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Reasons :Adverse event, lack of efficacy, remission and stop monitoring, remission and start monitor-and-extend, reimbursement issues, patients' decision, unknown
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Bayer
Industry
Belgian Retrospective Chart Review Evaluating Treat-and-extend With Eylea® in Treatment naïve Patients With Neovascular Age-related Macular Degeneration.
Acronym: BELUGA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03748784
Blindness, Eye Diseases
Bakersfield, California, United States
View Trial DetailsNCT04331730
Eye Diseases, Eye Diseases, Hereditary
Beverly Hills, California, United States
View Trial DetailsNCT04537884
Diabetes Mellitus, Diabetic Macular Edema
Beverly Hills, California, United States
View Trial DetailsNCT04704921
AMD, CNV
Phoenix, Arizona, United States
View Trial Details