An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting
Megadott ok: Sponsor Decision
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT06398080
- Record updated
- 2024. november 25.
- Original description
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).Read full original descriptionShow less
Real-World Patient Characteristics, Treatment Patterns, and Outcomes Among Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) Treated With Aflibercept 8 mg in the United States
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).
Inclusion: Any patient aged at least 50 years at the time of enrollment; Diagnosis of nAMD (per physician); 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; For treatment-naïve patient cohort, patients never receiving previous treatment in the study eye for nAMD, as defined in the protocol; Initiating treatment with aflibercept 8 mg for nAMD; Any patient aged at least 18 years at the time of enrollment; Macular edema associated with DME (per physician); Diagnosis of diabetes mellitus type 1 or type 2; 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; For treatment-naïve patient cohort, patients never previously treated with IVT agents or surgery/laser in the study eye for DME; Initiating treatment with aflibercept 8 mg for DME.
Exclusion: Any patients that have been treated with photodynamic therapy; Treatment with aflibercept 8 mg prior to baseline; Treatment with aflibercept 8 mg prior to baseline; NOTE: Other Protocol-Defined Inclusion / Exclusion Criteria Apply; Macular edema/hemorrhage/choroidal neovascularization due to any other cause besides nAMD; 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); Any systemic or ocular condition that would prevent any improvement of visual acuity in the study eye (eg, permanent visual impairment or blindness from any cause); Macular edema due to any other cause besides DME.