check_circleStudy Completed
Neovascular age-related macular degeneration
Bayer Identifier:
21573
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study reviewing medical records to learn more about treat-and-extend with Eylea in patients with neovascular age-related macular degeneration (nAMD).
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
330Trial Dates
December 2020 - June 2021Phase
Phase 4Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations | Many Locations, Belgium |
Primary Outcome
- Number of injections in the first 24 months of treatmentdate_rangeTime Frame:Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)
- Last injection interval in the 2nd year of treatmentdate_rangeTime Frame:Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)
Secondary Outcome
- Number of aflibercept injections during the 1st, 3rd and 4th year of treatmentdate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
- Last injection interval in the 1st, 3rd and 4th yeardate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
- Most stable interval between aflibercept injections in the 2nd, 3rd and 4th yearDefinition of ‘most stable injection interval according to the ophthalmologistdate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
- Number of monitoring visits during each year of the studydate_rangeTime Frame: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 studyBCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.date_rangeTime Frame: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).date_rangeTime Frame: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 Detachmentdate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
- Number of patients with absence of fluid or anatomical parameters (IRF/SRF/PED)date_rangeTime Frame:Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
- Reason for discontinuation of aflibercept treatment after 24 monthsReasons : Adverse event, lack of efficacy, remission and stop monitoring, remission and start monitor-and-extend, reimbursement issues, patients’ decision, unknowndate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
- Number of patients discontinuing aflibercept treatment within the first 24 monthsdate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
- Reason for discontinuation of aflibercept treatment during first 24 monthsReasons :Adverse event, lack of efficacy, remission and stop monitoring, remission and start monitor-and-extend, reimbursement issues, patients’ decision, unknowndate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
- Number of patients discontinuing aflibercept treatment after 24 monthsdate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
OtherAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A