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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06075147




Registration number
NCT06075147
Ethics application status
Date submitted
4/10/2023
Date registered
10/10/2023
Date last updated
27/06/2024

Titles & IDs
Public title
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
Scientific title
An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in DME and nAMD in a Real-world Setting
Secondary ID [1] 0 0
22480
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Visual Impairment 0 0
Neovascular Age-related Macular Degeneration (nAMD) 0 0
Diabetic Macula Edema (DME) 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)

naïve nAMD - Treatment-naive patients with nAMD

pretreated nAMD - Pretreated patients with nAMD

naïve DME - Treatment-naïve patients with DME

pretreated DME - Pretreated patients with DME


Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The change of best corrected visual acuity (BCVA) from baseline to 12 months as evaluated in routine clinical practice
Timepoint [1] 0 0
At baseline and 12 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
At baseline, 4 weeks, 8 weeks, 6 months and 24 months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months
Secondary outcome [6] 0 0
Number of participants with (serious) adverse events and (serious) drug-related adverse events
Timepoint [6] 0 0
From the first application of aflibercept 8 mg up to 24 months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2028
Actual
Sample size
Target
2500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Many Locations - Multiple Locations
Recruitment postcode(s) [1] 0 0
- Multiple Locations
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Multiple Locations
Country [2] 0 0
Denmark
State/province [2] 0 0
Multiple Locations
Country [3] 0 0
Finland
State/province [3] 0 0
Multiple Locations
Country [4] 0 0
France
State/province [4] 0 0
Multiple Locations
Country [5] 0 0
Germany
State/province [5] 0 0
Multiple Locations
Country [6] 0 0
Italy
State/province [6] 0 0
Multiple Locations
Country [7] 0 0
Japan
State/province [7] 0 0
Multiple Locations
Country [8] 0 0
Netherlands
State/province [8] 0 0
Multiple Locations
Country [9] 0 0
Norway
State/province [9] 0 0
Multiple Locations
Country [10] 0 0
Saudi Arabia
State/province [10] 0 0
Multiple Locations
Country [11] 0 0
Sweden
State/province [11] 0 0
Multiple Locations
Country [12] 0 0
Switzerland
State/province [12] 0 0
Multiple Locations
Country [13] 0 0
United Arab Emirates
State/province [13] 0 0
Multiple Locations
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Multiple Locations

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06075147
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
clinical-trials-contact@bayer.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06075147