check_circleStudy Completed
Wet Macular Degeneration
Bayer Identifier:infoA unique number for a trial given by Bayer.
17634
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
Aflibercept (Eylea) in roUtine clinical practice in patientS with wet age-related macular degeneration in Italy
Trial purpose
The main objectives of this non-interventional cohort field study are to evaluate effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a study population of “naïve” patients
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal info
912The overall number of participants needed for a trial.
Trial Dates info
January 2015 - July 2019Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 4A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Completed | Many Locations, Italy |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Mean change of visual acuity from baseline to 12 months.date_rangeTime Frame:Baseline to 12 monthsenhanced_encryptionNoSafety Issue:
- Mean change of visual acuity from baseline to 24 months.date_rangeTime Frame:Baseline to 24 monthsenhanced_encryptionNoSafety Issue:
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Number of clinical visits (visits for injections)date_rangeTime Frame:At 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Number of monitoring visits (visits only for diagnostic purposes, but without injections)date_rangeTime Frame:At 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Number of combined visits (visits for monitoring and injection)date_rangeTime Frame:At 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Number of post-injection monitoring visits (visits only for safety checks after injection)date_rangeTime Frame:At 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Number of visits outside the study center after 12 and 24 monthsdate_rangeTime Frame:At 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Number of optical coherence tomography (OCT) assessments per patientdate_rangeTime Frame:At 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Number of visual acuity testsdate_rangeTime Frame:At 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Number of fundoscopy examinationsdate_rangeTime Frame:At 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Mean time between the injections and visitsdate_rangeTime Frame:At 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Mean time between the first symptoms and diagnosisdate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Mean time from indication of the Eylea treatment by the treating physician to treatmentTime will be defined as difference in days between clinical indication for the treatment and the first injectiondate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Proportion of patients with no fluiddate_rangeTime Frame:At 4,12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Mean change in retinal thickness from baselineAs measured by OCT (SD-SLO) Optical Coherence Tomography ( Spectral Domain / Scanning Laser Ophthalmoscope)date_rangeTime Frame:Baseline and at 4,12 and 24 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type info
ObservationalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
N/AThe main reason the clinical trial is being done.
Allocation info
N/AAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
N/AAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
N/AA “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.