Observational study on the effectiveness of aflibercept for vision impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: (+)1-888-84 22937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Long-term safety test of the Axitinib implant for people with neovascular AMD who finished prior OTX-TKI studies

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• Ixo-vec gene therapy versus aflibercept for wet age-related macular degeneration (AQUARIUS)

  This study tests whether a single injection of Ixo-vec gene therapy can maintain or improve vision as well as regular aflibercept injections in adults aged 50 and older with active neovascular (wet) AMD.

  Recruiting at 79 sites Phase 3 Adverum Biotechnologies, Inc. · Mesa, Arizona and 78 other locations · NCT07482176

• LX102 gene therapy for neovascular (wet) age-related macular degeneration

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• Cognitive behavioral therapy plus mindfulness program to help people adjust to vision loss

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• Single intravitreal injection of 4D-150 for macular neovascularization from age-related macular degeneration

  This trial will try a single eye injection of 4D-150 versus standard aflibercept in adults 50 and older with neovascular (wet) AMD to see if it controls disease activity.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.