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

Visual Impairment Clinical Trial

— SPECTRUM-US  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398080
• Other study ID #: VGFTe-HD-OD-2331
• Status: Not yet recruiting
• Start date: August 12, 2024
• Est. completion date: November 13, 2028

Study information

• Verified date: April 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: November 13, 2028
• Est. primary completion date: November 13, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema (DME)
• Edema
• Macular Degeneration
• Macular Edema
• Neovascular Age-related Macular Degeneration (nAMD)
• Vision Disorders
• Vision, Low
• Visual Impairment
• Wet Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters)	Treatment-Naïve Patient Cohorts	Baseline up to 12 Months
Secondary	Change in VA (ETDRS letters)		Baseline up to 24 Months
Secondary	Categorical gains of =5 ETDRS letters		Up to 24 Months
Secondary	Categorical gains of =10 ETDRS letters		Up to 24 Months
Secondary	Categorical gains of =15 ETDRS letters		Up to 24 Months
Secondary	Categorical losses of =5 ETDRS letters		Up to 24 Months
Secondary	Categorical losses of =10 ETDRS letters		Up to 24 Months
Secondary	Categorical losses of =15 ETDRS letters		Up to 24 Months
Secondary	Proportion of patients achieving 20/40 Snellen equivalent or better		Up to 24 Months
Secondary	Change in Central subfield thickness (CST)		Baseline up to 24 Months
Secondary	Description of demographics	Standard and clinical characteristics such as age, sex and race/ethnicity	At Baseline
Secondary	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
Secondary	Treatment interval		Up to 24 Months
Secondary	Missed and unscheduled visits		Up to 24 Months
Secondary	Frequency of ocular adverse events (AEs)		Up to 24 Months
Secondary	Frequency of non-ocular adverse events (AEs)		Up to 24 Months