AzTrials
AzTrials

Neovascular Age-related Macular Degeneration (nAMD)SPECTRUM-USNCT06398080

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

An observational study of Neovascular Age-related Macular Degeneration (nAMD) and Wet Age-related Macular Degeneration (AMD), run by Regeneron Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
aflibercept 8 mg
How many people
0 participants
Where
No sites listed yet
Study dates
12 Dec 2024to 3 Jan 2029
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
  • NOTE: Other Protocol-Defined Inclusion / Exclusion Criteria Apply

About this study

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

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).

Being tested
aflibercept 8 mg
Keywords
Treatment-Naïve, Previously treated, Degenerative disease, Vascular endothelial growth factor (VEGF), Diabetic retinopathy (DR)
Medical subject headings
Vision Disorders, Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aflibercept 8 mgDrug

    Also called EYLEA® HD

    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.

Study groups in NCT06398080
Study groupRoleWhat they receive
Naïve nAMDTreatment-naive patients with nAMD
Receives: Drug: aflibercept 8 mg
Pretreated nAMDPatients with nAMD who have been previously treated with anti-VEGF and/or laser
Receives: Drug: aflibercept 8 mg
Naïve DMETreatment-naive patients with DME
Receives: Drug: aflibercept 8 mg
Pretreated DMEPatients with DME who have been previously treated with anti-VEGF, laser treatment, and/or intravitreal steroids
Receives: Drug: aflibercept 8 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 12 Months

  2. Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters)

    Treatment-Naïve Patient Cohorts

    Measured: Baseline up to 12 Months

Secondary outcomes (15)

  1. Change in VA (ETDRS letters)

    Measured: Baseline up to 24 Months

  2. Categorical gains of ≥5 ETDRS letters

    Measured: Up to 24 Months

  3. Categorical gains of ≥10 ETDRS letters

    Measured: Up to 24 Months

  4. Categorical gains of ≥15 ETDRS letters

    Measured: Up to 24 Months

  5. Categorical losses of ≥5 ETDRS letters

    Measured: Up to 24 Months

  6. Categorical losses of ≥10 ETDRS letters

    Measured: Up to 24 Months

  7. Categorical losses of ≥15 ETDRS letters

    Measured: Up to 24 Months

  8. Proportion of patients achieving 20/40 Snellen equivalent or better

    Measured: Up to 24 Months

  9. Change in Central subfield thickness (CST)

    Measured: Baseline up to 24 Months

  10. Description of demographics

    Standard and clinical characteristics such as age, sex and race/ethnicity

    Measured: At Baseline

  11. 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

    Measured: At Baseline

  12. Treatment interval

    Measured: Up to 24 Months

  13. Missed and unscheduled visits

    Measured: Up to 24 Months

  14. Frequency of ocular adverse events (AEs)

    Measured: Up to 24 Months

  15. Frequency of non-ocular adverse events (AEs)

    Measured: Up to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2024
  2. Study start12 Dec 2024 (estimated)
  3. Primary completion3 Jan 2028 (estimated)
  4. Study completion3 Jan 2029 (estimated)

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06398080
Sponsor's protocol ID
VGFTe-HD-OD-2331
Acronym
SPECTRUM-US
Status last verified
Nov 2024
First submitted
17 Apr 2024
Last updated
25 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neovascular Age-related Macular Degeneration (nAMD) and Wet Age-related Macular Degeneration (AMD), run by Regeneron Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean prior treatment interval during the one-year period before study enrollment compared to the last assigned treatment interval during the study (time frame: Up to 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06398080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in