Diabetic Macula Edema (DME), Neovascular Age-related Macular Degeneration (nAMD), Visual Impairment
Conditions
Brief summary
This is an observational study in which only data are collected from people who have already been prescribed aflibercept 8 mg by their own doctors. In this study, data from adults with visual impairment due to neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) will be collected and studied. Visual impairment is any degree of vision loss that affects a person's ability to perform daily activities. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems. Aflibercept 8 mg is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. Aflibercept 8 mg has been submitted for approval for the treatment of visual impairment due to nAMD and DME based on the results from 2 studies called PHOTON and PULSAR. This study will begin once approval is obtained. Currently, no real-world data are available for aflibercept 8 mg. The main purpose of this study is to collect more information about how well aflibercept 8 mg injection works in people with nAMD and DME. This study will include participants who have not received any prior treatment for nAMD or DME and participants who have. The main information that researchers will collect: the change in vision test scores called the best corrected visual acuity (BCVA) after 12 months of treatment. Data will be collected from February 2024 to September 2027 and will cover a period of up to 24 months per participant. The data will be collected using medical records and by interviewing the patients during regular visits that take place in routine practice. Researchers will observe participants from the first injection of aflibercept 8 mg until the end of the observation. In this study, only available data from regular visits will be collected. No visits or tests are required as part of this study.
Interventions
Following the manner of observational study, no intervention will be provided in the study. Any treatment decision, including the decision for aflibercept 8 mg treatment, is at the discretion of the attending physician, made in accordance with his/her experience and follows approved clinical guidelines.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for patients with nAMD * A diagnosis of nAMD * Patient aged ≥50 years * Patients for whom the decision to initiate treatment with intravitreal (IVT) aflibercept 8 mg according to a local product information was made as part of routine clinical practice * Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws) Inclusion criteria for patients with DME * A diagnosis of DME * Patient aged ≥18 years (or country's legal age of adulthood if the legal age is \>18 years) with type 1 or type 2 diabetes mellitus * Patients for whom the decision to initiate treatment with IVT aflibercept 8 mg according to a local product information was made as part of routine clinical practice * Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of best corrected visual acuity (BCVA) from baseline to 12 months as evaluated in routine clinical practice | At baseline and 12 months | BCVA measurements at baseline (first injection of aflibercept 8 mg) and at 12 months as ETDRS letters (according to the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or other methods (e.g. Snellen charts) used in the routine clinical practice in participating countries or sites (with conversion to ETDRS)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of best corrected visual acuity (BCVA) from baseline to 4 weeks, 8 weeks, 6 months, and 24 months as evaluated in routine clinical practice | At baseline, 4 weeks, 8 weeks, 6 months and 24 months | — |
| Number of aflibercept 8 mg injections in the study eye during the first 6 months, the first year (12 months), the second year (24 months), and the entire observation period (last visit), respectively | Up to 24 months | Performed intravitreal aflibercept 8 mg injections in study eye (including date) |
| Number of visits regarding the study eye by type of visit during the first 6 months, the first 12 months, and the 24 months treatment period | Up to 24 months | Performed different type of visits for study eye |
| Number of treated study eyes with 5, 10, and 15 letters (or equivalent) BCVA gain/loss from baseline at 4 weeks, 8 weeks, 6, 12, and 24 months | At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months | — |
| Change in central retinal thickness as measured by optical coherence tomography (OCT) from baseline to 4 weeks, 8 weeks, 6, 12, and 24 month follow up | At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months | — |
| Number of participants with (serious) adverse events and (serious) drug-related adverse events | From the first application of aflibercept 8 mg up to 24 months | — |
Countries
Australia, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom
Outcome results
None listed