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

Launched by BAYER · Oct 4, 2023

Keywords

ClinConnect Summary

The SPECTRUM Study is designed to gather information about how effective a medication called aflibercept 8 mg is for treating vision problems caused by two conditions: neovascular age-related macular degeneration (nAMD) and diabetic macula edema (DME). This study will involve adults who already have a prescription for aflibercept 8 mg from their doctors. Researchers will collect data on how participants' vision changes over the course of 12 months, mainly by looking at their vision test scores during regular doctor visits.

To be eligible for this study, participants need to be diagnosed with either nAMD (if they're 50 or older) or DME (if they're 18 or older with diabetes). They must also be starting treatment with aflibercept 8 mg based on their doctor’s recommendation. It's important to note that participation involves no extra visits or tests; data will only be collected during routine eye care appointments. This study will run from February 2024 to September 2027, and the goal is to provide valuable real-world insights on how well aflibercept 8 mg works for improving vision in these patients.

Gender

ALL

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