Clinical trial NCT06075147: 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
Official title: An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in DME and nAMD in a Real-world Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Visual Impairment
Neovascular Age-related Macular Degeneration (nAMD)
Diabetic Macula Edema (DME)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SPECTRUM will be performed in eye clinics and ophthalmology practices in several countries across North America, Europe, Middle East, and Asia Pacific.

Female and male patients (aged ≥ 18 years for the DME cohorts or ≥ 50 years for the nAMD cohorts) with a diagnosis of nAMD or DME can be enrolled after the decision for treatment with aflibercept 8 mg has been made by the treating physician. Indications, contraindications, risks, warnings, and precautions according to the local market authorization/local product information should be carefully considered.

For each patient a single eye will be considered as a study eye. The eye treated with aflibercept 8 mg will be considered as study eye. If treatment for both eyes is decided simultaneously, the study eye will be the worse eye as per discretion of the treating physician. Treatment of the 2nd eye will be considered as a concomitant treatment.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The change of best corrected visual acuity (BCVA) from baseline to 12 months as evaluated in routine clinical practice
timeFrame: At baseline and 12 months
Secondary outcomes:
measure: 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
timeFrame: At baseline, 4 weeks, 8 weeks, 6 months and 24 months
measure: 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
timeFrame: Up to 24 months
measure: 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
timeFrame: Up to 24 months
measure: 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
timeFrame: At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months
measure: 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
timeFrame: At baseline, 4 weeks, 8 weeks, 6, 12 and 24 months
measure: Number of participants with (serious) adverse events and (serious) drug-related adverse events
timeFrame: From the first application of aflibercept 8 mg up to 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Australia
facility: Many Locations
city: Multiple Locations
country: Canada
facility: Many Locations
city: Multiple Locations
country: Denmark
facility: Many Locations
city: Multiple Locations
country: Finland
facility: Many Locations
city: Multiple Locations
country: France
facility: Many Locations
city: Multiple Locations
country: Germany
facility: Many Locations
city: Multiple Locations
country: Italy
facility: Many Locations
city: Multiple Locations
country: Japan
facility: Many Locations
city: Multiple Locations
country: Korea, Republic of
facility: Many Locations
city: Multiple Locations
country: Netherlands
facility: Many Locations
city: Multiple Locations
country: Norway
facility: Many Locations
city: Multiple Locations
country: Portugal
facility: Many Locations
city: Multiple Locations
country: Saudi Arabia
facility: Many Locations
city: Multiple Locations
country: Spain
facility: Many Locations
city: Multiple Locations
country: Sweden
facility: Many Locations
city: Multiple Locations
country: Switzerland
facility: Many Locations
city: Multiple Locations
country: United Arab Emirates
facility: Many Locations
city: Multiple Locations
country: United Kingdom
facility: Many Locations
Study officials:
References: