Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (nAMD), Visual Impairment, Wet Age-related Macular Degeneration (AMD)
Conditions
Keywords
Treatment-Naïve, Previously treated, Degenerative disease, Vascular endothelial growth factor (VEGF), Diabetic retinopathy (DR)
Brief summary
The purpose of this research study is to observe the patient's clinical care and how EYLEA® HD is used as a treatment in real-world settings. Patients are asked to join the study because they have either neovascular age-related macular degeneration (nAMD/wet age-related macular degeneration \[AMD\]) or diabetic macular edema (DME). Patients cannot have used EYLEA® HD in the past and the doctor must be planning to treat nAMD or DME with a new prescription of EYLEA® HD (aflibercept 8 mg).
Interventions
DRUGaflibercept 8 mg
No intervention will be provided to study patients. 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 following approved clinical guidelines.
Sponsors
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria for Patients with nAMD: 1. Any patient aged at least 50 years at the time of enrollment 2. Diagnosis of nAMD (per physician) 3. Previously treated patient cohort, patients that had treatment with any ocular intervention for nAMD in the study eye at any time before starting aflibercept 8 mg, as defined in the protocol 4. For treatment-naïve patient cohort, patients never receiving previous treatment in the study eye for nAMD, as defined in the protocol 5. Initiating treatment with aflibercept 8 mg for nAMD Key Inclusion Criteria for Patients with DME: 1. Any patient aged at least 18 years at the time of enrollment 2. Macular edema associated with DME (per physician) 3. Diagnosis of diabetes mellitus type 1 or type 2 4. For previously treated patient cohort, treatment with another intravitreal (IVT) anti-VEGF agent(s) or IVT steroids, or surgery/laser for DME in the study eye at any time before starting aflibercept 8 mg, as described in the protocol 5. For treatment-naïve patient cohort, patients never previously treated with IVT agents or surgery/laser in the study eye for DME 6. Initiating treatment with aflibercept 8 mg for DME Key
Exclusion criteria
for Patients with nAMD 1. Macular edema/hemorrhage/choroidal neovascularization due to any other cause besides nAMD 2. Any systemic or ocular condition that would prevent any improvement of VA in the study eye (eg, permanent visual impairment or blindness from any cause) 3. Any patients that have been treated with photodynamic therapy 4. Treatment with aflibercept 8 mg prior to baseline Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean prior treatment interval during the one-year period before study enrollment compared to the last assigned treatment interval during the study | Up to 12 Months | Previously Treated Patient Cohorts: Reported among the subsets of patients (nAMD and DME) treated at dosing intervals of ≤ 8 weeks for ≥ 6 months prior to enrollment |
| Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters) | Baseline up to 12 Months | Treatment-Naïve Patient Cohorts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Categorical gains of ≥10 ETDRS letters | Up to 24 Months | — |
| Categorical gains of ≥15 ETDRS letters | Up to 24 Months | — |
| Categorical losses of ≥5 ETDRS letters | Up to 24 Months | — |
| Categorical losses of ≥10 ETDRS letters | Up to 24 Months | — |
| Categorical losses of ≥15 ETDRS letters | Up to 24 Months | — |
| Proportion of patients achieving 20/40 Snellen equivalent or better | Up to 24 Months | — |
| Change in VA (ETDRS letters) | Baseline up to 24 Months | — |
| Description of demographics | At Baseline | Standard and clinical characteristics such as age, sex and race/ethnicity |
| Descriptions of study eye characteristics | At Baseline | Study eye characteristics include ocular history, medical history (duration of nAMD or DME), prior and concomitant medication history, prior and concomitant ocular surgeries |
| Treatment interval | Up to 24 Months | — |
| Missed and unscheduled visits | Up to 24 Months | — |
| Frequency of ocular adverse events (AEs) | Up to 24 Months | — |
| Frequency of non-ocular adverse events (AEs) | Up to 24 Months | — |
| Change in Central subfield thickness (CST) | Baseline up to 24 Months | — |
| Categorical gains of ≥5 ETDRS letters | Up to 24 Months | — |
Outcome results
None listed