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

Visual Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075147
• Other study ID #: 22480
• Status: Recruiting
• Start date: February 15, 2024
• Est. completion date: January 31, 2028

Study information

• Verified date: April 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: January 31, 2028
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Degeneration
• Neovascular Age-related Macular Degeneration (nAMD)
• Vision Disorders
• Vision, Low
• Visual Impairment
• Wet Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
Australia	Many Locations	Multiple Locations
Canada	Many Locations	Multiple Locations
Denmark	Many Locations	Multiple Locations
Finland	Many Locations	Multiple Locations
France	Many Locations	Multiple Locations
Germany	Many Locations	Multiple Locations
Italy	Many Locations	Multiple Locations
Japan	Many Locations	Multiple Locations
Netherlands	Many Locations	Multiple Locations
Norway	Many Locations	Multiple Locations
Saudi Arabia	Many Locations	Multiple Locations
Sweden	Many Locations	Multiple Locations
Switzerland	Many Locations	Multiple Locations
United Arab Emirates	Many Locations	Multiple Locations
United Kingdom	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  Canada,  Denmark,  Finland,  France,  Germany,  Italy,  Japan,  Netherlands,  Norway,  Saudi Arabia,  Sweden,  Switzerland,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)	Up to 24 months
Secondary	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	Up to 24 months
Secondary	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
Secondary	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
Secondary	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

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