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

NCT06075147 | Active Not Recruiting

• 1 other identifier: 22480
• Study Type: observational
• Target: 2,500
• Locations: 18 countries
• Sites: 18

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

Outcome Measures

Primary Outcomes (1)

• The change of best corrected visual acuity (BCVA) from baseline to 12 months as evaluated in routine clinical practice

  BCVA measurements at baseline (first injection of aflibercept 8 mg) and at 12 months as ETDRS letters (according to the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or other methods (e.g. Snellen charts) used in the routine clinical practice in participating countries or sites (with conversion to ETDRS))

  At baseline and 12 months

Secondary Outcomes (6)

• The change of best corrected visual acuity (BCVA) from baseline to 4 weeks, 8 weeks, 6 months, and 24 months as evaluated in routine clinical practice

  At baseline, 4 weeks, 8 weeks, 6 months and 24 months

• Number of aflibercept 8 mg injections in the study eye during the first 6 months, the first year (12 months), the second year (24 months), and the entire observation period (last visit), respectively

  Up to 24 months

• Number of visits regarding the study eye by type of visit during the first 6 months, the first 12 months, and the 24 months treatment period

  Up to 24 months

• Number of treated study eyes with 5, 10, and 15 letters (or equivalent) BCVA gain/loss from baseline at 4 weeks, 8 weeks, 6, 12, and 24 months

  At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months

• Change in central retinal thickness as measured by optical coherence tomography (OCT) from baseline to 4 weeks, 8 weeks, 6, 12, and 24 month follow up

  At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months

Study Arms (4)

naïve nAMD

Treatment-naive patients with nAMD

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

pretreated nAMD

Pretreated patients with nAMD

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

naïve DME

Treatment-naïve patients with DME

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

pretreated DME

Pretreated patients with DME

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

Interventions

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

SPECTRUM will be performed in eye clinics and ophthalmology practices in several countries across North America, Europe, Middle East, and Asia Pacific. Female and male patients (aged ≥ 18 years for the DME cohorts or ≥ 50 years for the nAMD cohorts) with a diagnosis of nAMD or DME can be enrolled after the decision for treatment with aflibercept 8 mg has been made by the treating physician. Indications, contraindications, risks, warnings, and precautions according to the local market authorization/local product information should be carefully considered. For each patient a single eye will be considered as a study eye. The eye treated with aflibercept 8 mg will be considered as study eye. If treatment for both eyes is decided simultaneously, the study eye will be the worse eye as per discretion of the treating physician. Treatment of the 2nd eye will be considered as a concomitant treatment.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (18)

Many Locations

Multiple Locations, Australia

Location

Many Locations

Multiple Locations, Canada

Location

Many Locations

Multiple Locations, Denmark

Location

Many Locations

Multiple Locations, Finland

Location

Many Locations

Multiple Locations, France

Location

Many Locations

Multiple Locations, Germany

Location

Many Locations

Multiple Locations, Italy

Location

Many Locations

Multiple Locations, Japan

Location

Many Locations

Multiple Locations, Netherlands

Location

Many Locations

Multiple Locations, Norway

Location

Many Locations

Multiple Locations, Portugal

Location

Many Locations

Multiple Locations, Saudi Arabia

Location

Many Locations

Multiple Locations, South Korea

Location

Many Locations

Multiple Locations, Spain

Location

Many Locations

Multiple Locations, Sweden

Location

Many Locations

Multiple Locations, Switzerland

Location

Many Locations

Multiple Locations, United Arab Emirates

Location

Many Locations

Multiple Locations, United Kingdom

Location

MeSH Terms

Conditions

Vision Disorders

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: February 15, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); AE (1); KR (1); JP (1); GB (1); SA (1); SE (1); AU (1); CH (1); PT (1); NO (1); FI (1); ES (1); DK (1); FR (1); CA (1); IT (1); NL (1)