Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Bayer
Conditions:
Visual Impairment
Neovascular Age-related Macular Degeneration (nAMD)
Eligibility:
All Genders
18+ years
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 impairm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2028
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT06075147
Start Date
February 15 2024
End Date
January 31 2028
Last Update
January 5 2026
Active Locations (18)
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Multiple Locations, Australia
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Multiple Locations, Canada
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Multiple Locations, Denmark
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Multiple Locations, Finland