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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

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
Spain
State/province [11] 0 0
Multiple Locations
Country [12] 0 0
Sweden
State/province [12] 0 0
Multiple Locations
Country [13] 0 0
Switzerland
State/province [13] 0 0
Multiple Locations
Country [14] 0 0
United Arab Emirates
State/province [14] 0 0
Multiple Locations
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Multiple Locations

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06075147