Recruiting

Visual impairment, Neovascular age-related macular degeneration (nAMD), Diabetic macula edema (DME)

Bayer Identifier:

22480

ClinicalTrials.gov Identifier:

NCT06075147

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 Years

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 of routine clinical practice
- Signed informed patient consent before the start of data collection (according to the 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 >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
Exclusion criteria for all patients with nAMD
- 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
- Any medication interfering with aflibercept 8 mg in the intravitreal aflibercept 8 mg local product information
Additional exclusion criteria for treatment-naïve patients with nAMD
- Any prior ocular treatment in the study eye or systemic treatment in nAMD
Additional exclusion 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 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

Exclusion criteria for all patients with DME
- 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
- Previous treatment of the study eye with laser in the last 90 days prior to first IVT aflibercept 8 mg
Additional exclusion criteria for treatment-naïve patients with DME
- Any prior ocular treatment in the study eye or systemic treatment in DME
Additional exclusion 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 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

Trial summary

Enrollment Goal

2500

Trial Dates

February 2024 - January 2028

Phase

Phase 4

Could I Receive a placebo

Products

Aflibercept (VEGF Trap-Eye, BAY86-5321)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Recruiting	Many Locations	Many Locations, United Arab Emirates
Recruiting	Many Locations	Many Locations, Canada
Recruiting	Many Locations	Many Locations, Switzerland
Recruiting	Many Locations	Many Locations, Germany
Recruiting	Many Locations	Many Locations, Denmark
Recruiting	Many Locations	Many Locations, Finland
Recruiting	Many Locations	Many Locations, France
Active, not recruiting	Many Locations	Many Locations, United Kingdom
Recruiting	Many Locations	Many Locations, Italy
Recruiting	Many Locations	Many Locations, Japan
Recruiting	Many Locations	Many Locations, Netherlands
Recruiting	Many Locations	Many Locations, Norway
Recruiting	Many Locations	Many Locations, Saudi Arabia
Recruiting	Many Locations	Many Locations, Sweden
Recruiting	Many Locations	Many Locations, Australia
Recruiting	Many Locations	Many Locations, Spain
Recruiting	Many Locations	Many Locations, Korea,_republic_of
Recruiting	Many Locations	Many Locations, Portugal

Primary Outcome

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))
Time Frame:
At baseline and 12 months

Secondary Outcome

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
Time Frame:
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
Performed intravitreal aflibercept 8 mg injections in study eye (including date)
Time Frame:
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
Performed different type of visits for study eye
Time Frame:
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
Time Frame:
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
Time Frame:
At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months
Number of participants with (serious) adverse events and (serious) drug-related adverse events
Time Frame:
From the first application of aflibercept 8 mg up to 24 months

Trial design

An observational study program to investigate the effectiveness of aflibercept 8 mg used in DME and nAMD in a real-world setting

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

Other

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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