Clinical trial NCT06398080: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Neovascular Age-related Macular Degeneration (nAMD)
Wet Age-related Macular Degeneration (AMD)
Diabetic Macular Edema (DME)
Visual Impairment
Keywords: Treatment-Naïve
Previously treated
Degenerative disease
Vascular endothelial growth factor (VEGF)
Diabetic retinopathy (DR)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Previously treated and treatment-naïve patients that have a diagnosis of nAMD or DME will be enrolled into this study. Patients who are treated with aflibercept 8 mg for other indications besides nAMD or DME will not be included.

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).


Eligibility 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 Exclusion Criteria for Patients with DME:

1. Macular edema due to any other cause besides DME
2. 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)
3. Treatment with aflibercept 8 mg prior to baseline

NOTE: Other Protocol-Defined Inclusion / Exclusion Criteria Apply

Primary outcomes:
measure: 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
measure: Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters)
timeFrame: Baseline up to 12 Months
Secondary outcomes:
measure: Change in VA (ETDRS letters)
timeFrame: Baseline up to 24 Months
measure: Categorical gains of ≥5 ETDRS letters
timeFrame: Up to 24 Months
measure: Categorical gains of ≥10 ETDRS letters
timeFrame: Up to 24 Months
measure: Categorical gains of ≥15 ETDRS letters
timeFrame: Up to 24 Months
measure: Categorical losses of ≥5 ETDRS letters
timeFrame: Up to 24 Months
measure: Categorical losses of ≥10 ETDRS letters
timeFrame: Up to 24 Months
measure: Categorical losses of ≥15 ETDRS letters
timeFrame: Up to 24 Months
measure: Proportion of patients achieving 20/40 Snellen equivalent or better
timeFrame: Up to 24 Months
measure: Change in Central subfield thickness (CST)
timeFrame: Baseline up to 24 Months
measure: Description of demographics
timeFrame: At Baseline
measure: Descriptions of study eye characteristics
timeFrame: At Baseline
measure: Treatment interval
timeFrame: Up to 24 Months
measure: Missed and unscheduled visits
timeFrame: Up to 24 Months
measure: Frequency of ocular adverse events (AEs)
timeFrame: Up to 24 Months
measure: Frequency of non-ocular adverse events (AEs)
timeFrame: Up to 24 Months
Other outcomes:
Locations:
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: