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

NCT ID: NCT06075147

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2028-01-31

Brief 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.

Conditions

Visual Impairment; Neovascular Age-related Macular Degeneration (nAMD); Diabetic Macula Edema (DME)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

naïve nAMD

Treatment-naive patients with nAMD

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

Intervention Type: DRUG

Following the manner of observational study, no intervention will be provided in the study. 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 follows approved clinical guidelines.

pretreated nAMD

Pretreated patients with nAMD

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

Intervention Type: DRUG

Following the manner of observational study, no intervention will be provided in the study. 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 follows approved clinical guidelines.

naïve DME

Treatment-naïve patients with DME

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

Intervention Type: DRUG

Following the manner of observational study, no intervention will be provided in the study. 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 follows approved clinical guidelines.

pretreated DME

Pretreated patients with DME

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

Intervention Type: DRUG

Following the manner of observational study, no intervention will be provided in the study. 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 follows approved clinical guidelines.

Interventions

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

Following the manner of observational study, no intervention will be provided in the study. 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 follows approved clinical guidelines.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 of routine clinical practice
• Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws)

• A diagnosis of DME
• Patient aged ≥18 years (or country's legal age of adulthood if the legal age is >18 years) with type 1 or type 2 diabetes mellitus
• Patients for whom the decision to initiate treatment with IVT aflibercept 8 mg according to a local product information was made as part of routine clinical practice
• Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws)

Exclusion Criteria

• Participation in an investigational program with interventions outside of clinical routine practice
• Contraindications as listed in the local intravitreal aflibercept 8 mg local product information
• Extra/periocular infection or inflammation in either eye at time of first injection
• Patient receiving other intravitreal treatments other than aflibercept in the fellow eye
• 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 3 months
• 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

• Participation in an investigational program with interventions outside of clinical routine practice
• Contraindications as listed in the intravitreal aflibercept 8 mg local product information
• Extra/periocular infection or inflammation in either eye at time of first injection
• Patient receiving other intravitreal treatments other than aflibercept in the fellow eye
• Any medication interfering with aflibercept 8 mg in the intravitreal aflibercept 8 mg local product information
• 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 3 months
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Many Locations

Multiple Locations, , Australia

Many Locations

Multiple Locations, , Canada

Many Locations

Multiple Locations, , Denmark

Many Locations

Multiple Locations, , Finland

Many Locations

Multiple Locations, , France

Many Locations

Multiple Locations, , Germany

Many Locations

Multiple Locations, , Italy

Many Locations

Multiple Locations, , Japan

Many Locations

Multiple Locations, , Netherlands

Many Locations

Multiple Locations, , Norway

Many Locations

Multiple Locations, , Portugal

Many Locations

Multiple Locations, , Saudi Arabia

Many Locations

Multiple Locations, , South Korea

Many Locations

Multiple Locations, , Spain

Many Locations

Multiple Locations, , Sweden

Many Locations

Multiple Locations, , Switzerland

Many Locations

Multiple Locations, , United Arab Emirates

Many Locations

Multiple Locations, , United Kingdom

Countries

Australia; Canada; Denmark; Finland; France; Germany; Italy; Japan; Netherlands; Norway; Portugal; Saudi Arabia; South Korea; Spain; Sweden; Switzerland; United Arab Emirates; United Kingdom

Related Links

https://clinicaltrials.bayer.com/

Click here for access to information about Bayer's transparency standards and Bayer studies.

Other Identifiers

22480

Identifier Type: -

Identifier Source: org_study_id