Observational study on the effectiveness of aflibercept for vision impairment

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

This study looks at how well aflibercept helps adults with vision problems from age-related macular degeneration or diabetic macula edema in everyday treatment settings.

Quick facts

• Study type: Observational
• Enrollment: 2500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bayer (industry)
• Locations: 18 sites (Multiple Locations and 17 other locations)
• Trial ID: NCT06075147 on ClinicalTrials.gov

What this trial studies

This observational study collects data from adults who have been prescribed aflibercept 8 mg for treating visual impairment due to neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME). The study aims to understand how well this treatment works in real-world clinical settings. Participants include those diagnosed with nAMD or DME who are receiving treatment as part of routine clinical practice. Data will be gathered to assess the outcomes of the treatment over time.

Who should consider this trial

Good fit: Ideal candidates include adults aged 50 and older with nAMD or adults aged 18 and older with DME who are starting treatment with aflibercept.

Not a fit: Patients who do not have a diagnosis of nAMD or DME, or those who are not starting treatment with aflibercept, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of aflibercept in improving vision for patients with nAMD and DME.

How similar studies have performed: Other studies have shown positive outcomes with aflibercept for similar conditions, indicating that this approach is supported by prior evidence.

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

Where this trial is running

Multiple Locations and 17 other locations

• Many Locations — Multiple Locations, Australia (RECRUITING)
• Many Locations — Multiple Locations, Canada (RECRUITING)
• Many Locations — Multiple Locations, Denmark (RECRUITING)
• Many Locations — Multiple Locations, Finland (RECRUITING)
• Many Locations — Multiple Locations, France (RECRUITING)
• Many Locations — Multiple Locations, Germany (RECRUITING)
• Many Locations — Multiple Locations, Italy (RECRUITING)
• Many Locations — Multiple Locations, Japan (RECRUITING)
• Many Locations — Multiple Locations, Korea, Republic of (RECRUITING)
• Many Locations — Multiple Locations, Netherlands (RECRUITING)
• Many Locations — Multiple Locations, Norway (NOT_YET_RECRUITING)
• Many Locations — Multiple Locations, Portugal (RECRUITING)
• Many Locations — Multiple Locations, Saudi Arabia (RECRUITING)
• Many Locations — Multiple Locations, Spain (RECRUITING)
• Many Locations — Multiple Locations, Sweden (RECRUITING)
• Many Locations — Multiple Locations, Switzerland (RECRUITING)
• Many Locations — Multiple Locations, United Arab Emirates (RECRUITING)
• Many Locations — Multiple Locations, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Bayer Clinical Trials Contact

Conditions: Visual Impairment, Neovascular Age-related Macular Degeneration, Diabetic Macula Edema