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

NCT06398080 | Withdrawn

• 1 other identifier: VGFTe-HD-OD-2331
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

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)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• 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

Study Arms (4)

Naïve nAMD

Treatment-naive patients with nAMD

Drug: aflibercept 8 mg

Pretreated nAMD

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

Drug: aflibercept 8 mg

Naïve DME

Treatment-naive patients with DME

Drug: aflibercept 8 mg

Pretreated DME

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

Drug: aflibercept 8 mg

Interventions

aflibercept 8 mg DRUG

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.

Also known as: EYLEA® HD

Naïve DME; Naïve nAMD; Pretreated DME; Pretreated nAMD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Any patient aged at least 50 years at the time of enrollment
• Diagnosis of nAMD (per physician)
• 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
• For treatment-naïve patient cohort, patients never receiving previous treatment in the study eye for nAMD, as defined in the protocol
• Initiating treatment with aflibercept 8 mg for nAMD
• Any patient aged at least 18 years at the time of enrollment
• Macular edema associated with DME (per physician)
• Diagnosis of diabetes mellitus type 1 or type 2
• 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
• For treatment-naïve patient cohort, patients never previously treated with IVT agents or surgery/laser in the study eye for DME
• Initiating treatment with aflibercept 8 mg for DME

You may not qualify if:

• Macular edema/hemorrhage/choroidal neovascularization due to any other cause besides nAMD
• 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)
• Any patients that have been treated with photodynamic therapy
• Treatment with aflibercept 8 mg prior to baseline
• Macular edema due to any other cause besides DME
• 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)
• Treatment with aflibercept 8 mg prior to baseline

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Vision Disorders; Diabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: May 3, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): January 3, 2028
• Study Completion (Estimated): January 3, 2029
• Last Updated: November 25, 2024

Record last verified: 2024-11