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)

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).

Study Overview

• Status: Withdrawn
• Conditions: Visual Impairment; Diabetic Macular Edema (DME); Neovascular Age-related Macular Degeneration (nAMD); Wet Age-related Macular Degeneration (AMD)
• Intervention / Treatment: Drug: aflibercept 8 mg

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Naïve nAMD; Treatment-naive patients with nAMD	Drug: 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 Names: EYLEA® HD
Pretreated nAMD; Patients with nAMD who have been previously treated with anti-VEGF and/or laser	Drug: 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 Names: EYLEA® HD
Naïve DME; Treatment-naive patients with DME	Drug: 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 Names: EYLEA® HD
Pretreated DME; Patients with DME who have been previously treated with anti-VEGF, laser treatment, and/or intravitreal steroids	Drug: 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 Names: EYLEA® HD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean prior treatment interval during the one-year period before study enrollment compared to the last assigned treatment interval during the study	Previously Treated Patient Cohorts: Reported among the subsets of patients (nAMD and DME) treated at dosing intervals of ≤ 8 weeks for ≥ 6 months prior to enrollment	Up to 12 Months
Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters)	Treatment-Naïve Patient Cohorts	Baseline up to 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VA (ETDRS letters)		Baseline up to 24 Months
Categorical gains of ≥5 ETDRS letters		Up to 24 Months
Categorical gains of ≥10 ETDRS letters		Up to 24 Months
Categorical gains of ≥15 ETDRS letters		Up to 24 Months
Categorical losses of ≥5 ETDRS letters		Up to 24 Months
Categorical losses of ≥10 ETDRS letters		Up to 24 Months
Categorical losses of ≥15 ETDRS letters		Up to 24 Months
Proportion of patients achieving 20/40 Snellen equivalent or better		Up to 24 Months
Change in Central subfield thickness (CST)		Baseline up to 24 Months
Description of demographics	Standard and clinical characteristics such as age, sex and race/ethnicity	At Baseline
Descriptions of study eye characteristics	Study eye characteristics include ocular history, medical history (duration of nAMD or DME), prior and concomitant medication history, prior and concomitant ocular surgeries	At Baseline
Treatment interval		Up to 24 Months
Missed and unscheduled visits		Up to 24 Months
Frequency of ocular adverse events (AEs)		Up to 24 Months
Frequency of non-ocular adverse events (AEs)		Up to 24 Months

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): December 12, 2024
• Primary Completion (Estimated): January 3, 2028
• Study Completion (Estimated): January 3, 2029

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Previously treated; Treatment-Naïve; Vascular endothelial growth factor (VEGF); Degenerative disease; Diabetic retinopathy (DR)
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Sensation Disorders; Retinal Diseases; Retinal Degeneration; Vision, Low; Edema; Macular Degeneration; Macular Edema; Wet Macular Degeneration; Vision Disorders; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: VGFTe-HD-OD-2331

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes