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 (SPECTRUM-US)

Regeneron Pharmaceuticals

Status: Withdrawn

Conditions: Neovascular Age-related Macular Degeneration (nAMD); Diabetic Macular Edema (DME); Wet Age-related Macular Degeneration (AMD); Visual Impairment

Treatments: Drug: aflibercept 8 mg

Study type: Observational

Funder types: Industry

Identifiers

NCT06398080

VGFTe-HD-OD-2331

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

0 participants in 4 patient groups

Naïve nAMD

Description:

Treatment-naive patients with nAMD

Treatment:

Drug: aflibercept 8 mg

Pretreated nAMD

Description:

Patients with nAMD who have been previously treated with anti-VEGF and/or laser

Treatment:

Drug: aflibercept 8 mg

Naïve DME

Description:

Treatment-naive patients with DME

Treatment:

Drug: aflibercept 8 mg

Pretreated DME

Description:

Patients with DME who have been previously treated with anti-VEGF, laser treatment, and/or intravitreal steroids

Treatment:

Drug: aflibercept 8 mg

Sponsor of this trial

Lead Sponsor

Regeneron Pharmaceuticals