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

Sponsor

Bayer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06075147

Collaborator

(none)

2,500

Enrollment

Locations

Anticipated Duration (Months)

416.7

Patients Per Site

8.7

Patients Per Site Per Month

Study Details

Study Description

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 November 2023 to August 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.

Condition or Disease	Intervention/Treatment	Phase
Visual Impairment Neovascular Age-related Macular Degeneration (nAMD) Diabetic Macula Edema (DME)	Drug: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)

Study Design

Study Type:

Observational

Anticipated Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in DME and nAMD in a Real-world Setting.

Anticipated Study Start Date :

Jan 30, 2024

Anticipated Primary Completion Date :

Oct 31, 2027

Anticipated Study Completion Date :

Jan 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
naïve nAMD Treatment-naive patients with nAMD	Drug: 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.
pretreated nAMD Pretreated patients with nAMD	Drug: 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.
naïve DME Treatment-naïve patients with DME	Drug: 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.
pretreated DME Pretreated patients with DME	Drug: 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
Performed intravitreal aflibercept 8 mg injections in study eye (including date)
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]
Performed different type of visits for study eye
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]
Number of participants with (serious) adverse events and (serious) drug-related adverse events [From the first application of aflibercept 8 mg up to 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 within the last 6 months
Any concurrent drug releasing implant in the study eye

Contacts and Locations

Locations

	Site	City	Country
1	Many Locations	Multiple Locations	Australia
2	Many Locations	Multiple Locations	Canada
3	Many Locations	Multiple Locations	France
4	Many Locations	Multiple Locations	Germany
5	Many Locations	Multiple Locations	Japan
6	Many Locations	Multiple Locations	United Kingdom