An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Ne… (NCT06398080) | Clinical Trial Compass
WithdrawnNot Applicable
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
Stopped: Sponsor Decision
0Started 2024-12-12
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Macular edema/hemorrhage/choroidal neovascularization due to any other cause besides nAMD
What they're measuring
1
Mean prior treatment interval during the one-year period before study enrollment compared to the last assigned treatment interval during the study
Timeframe: Up to 12 Months
2
Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters)
. 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 patients that have been treated with photodynamic therapy
✕. Treatment with aflibercept 8 mg prior to baseline
✕. Macular edema due to any other cause besides DME
✕. 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)
✕. Treatment with aflibercept 8 mg prior to baseline