The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema

Last updated: April 24, 2025
Sponsor: Bayer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blurred Vision

Vision Loss

Macular Degeneration

Treatment

Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)

Clinical Study ID

NCT06075147
22480
  • Ages > 18
  • All Genders

Study Summary

This is an observational study in which only data are collected from people who have already been prescribed aflibercept 8 mg by their own doctors.

In this study, data from adults with visual impairment due to neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) will be collected and studied.

Visual impairment is any degree of vision loss that affects a person's ability to perform daily activities. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems.

Aflibercept 8 mg is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye.

Aflibercept 8 mg has been submitted for approval for the treatment of visual impairment due to nAMD and DME based on the results from 2 studies called PHOTON and PULSAR. This study will begin once approval is obtained. Currently, no real-world data are available for aflibercept 8 mg.

The main purpose of this study is to collect more information about how well aflibercept 8 mg injection works in people with nAMD and DME. This study will include participants who have not received any prior treatment for nAMD or DME and participants who have.

The main information that researchers will collect:

the change in vision test scores called the best corrected visual acuity (BCVA) after 12 months of treatment.

Data will be collected from February 2024 to September 2027 and will cover a period of up to 24 months per participant. The data will be collected using medical records and by interviewing the patients during regular visits that take place in routine practice.

Researchers will observe participants from the first injection of aflibercept 8 mg until the end of the observation.

In this study, only available data from regular visits will be collected. No visits or tests are required as part of this study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Inclusion criteria for patients with nAMD

  • A diagnosis of nAMD

  • Patient aged ≥50 years

  • Patients for whom the decision to initiate treatment with intravitreal (IVT)aflibercept 8 mg according to a local product information was made as part ofroutine clinical practice

  • Signed informed patient consent before the start of data collection (according tothe requirements of the local authorities and laws)

Inclusion criteria for patients with DME

  • A diagnosis of DME

  • Patient aged ≥18 years (or country's legal age of adulthood if the legal age is >18years) with type 1 or type 2 diabetes mellitus

  • Patients for whom the decision to initiate treatment with IVT aflibercept 8 mgaccording to a local product information was made as part of routine clinicalpractice

  • Signed informed patient consent before the start of data collection (according tothe requirements of the local authorities and laws)

Exclusion

Exclusion Criteria:

Exclusion criteria for all patients with nAMD

  • Participation in an investigational program with interventions outside of clinicalroutine practice

  • Contraindications as listed in the local intravitreal aflibercept 8 mg local productinformation

  • Extra/periocular infection or inflammation in either eye at time of first injection

  • Patient receiving other intravitreal treatments other than aflibercept in the felloweye

  • Any medication interfering with aflibercept 8 mg in the intravitreal aflibercept 8mg local product information Additional exclusion criteria for treatment-naïvepatients with nAMD

  • Any prior ocular treatment in the study eye or systemic treatment in nAMD Additionalexclusion criteria for pretreated patients with nAMD

  • Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days

  • Prior treatment with intravitreal corticosteroid in the study eye within the last 3months

  • Fluocinolone implant in the study eye within the last 3 years

  • Dexamethasone implant in the study eye within the last 6 months

  • Any concurrent drug releasing implant in the study eye

Exclusion criteria for all patients with DME

  • Participation in an investigational program with interventions outside of clinicalroutine practice

  • Contraindications as listed in the intravitreal aflibercept 8 mg local productinformation

  • Extra/periocular infection or inflammation in either eye at time of first injection

  • Patient receiving other intravitreal treatments other than aflibercept in the felloweye

  • Any medication interfering with aflibercept 8 mg in the intravitreal aflibercept 8mg local product information

  • Previous treatment of the study eye with laser in the last 90 days prior to firstIVT aflibercept 8 mg Additional exclusion criteria for treatment-naïve patients withDME

  • Any prior ocular treatment in the study eye or systemic treatment in DME Additionalexclusion criteria for pretreated patients with DME

  • Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days

  • Prior treatment with intravitreal corticosteroid in the study eye within the last 3months

  • Fluocinolone implant in the study eye within the last 3 years

  • Dexamethasone implant in the study eye within the last 6 months

  • Any concurrent drug releasing implant in the study eye

Study Design

Total Participants: 2500
Treatment Group(s): 1
Primary Treatment: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)
Phase:
Study Start date:
February 15, 2024
Estimated Completion Date:
January 31, 2028

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