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
NCT ID: NCT06398080
Last Updated: 2024-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2024-12-12
2029-01-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Naïve nAMD
Treatment-naive patients with nAMD
aflibercept 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.
Pretreated nAMD
Patients with nAMD who have been previously treated with anti-VEGF and/or laser
aflibercept 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.
Naïve DME
Treatment-naive patients with DME
aflibercept 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.
Pretreated DME
Patients with DME who have been previously treated with anti-VEGF, laser treatment, and/or intravitreal steroids
aflibercept 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.
Interventions
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aflibercept 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
Exclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Other Identifiers
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VGFTe-HD-OD-2331
Identifier Type: -
Identifier Source: org_study_id
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