account_circleRecruiting

Neovascular Glaucoma

Bayer Identifier:

21220

ClinicalTrials.gov Identifier:

NCT04519619

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to learn more about safety of aflibercept injection in Japanese patients with neovascular glaucoma (NVG)

Trial purpose

This is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of Neovascular Glaucoma. The investigator will have made the decision to use Eylea for treatment.

The objective of this study is to assess safety and effectiveness of Eylea using in real clinical practice. Patients will be followed for a time period of 6 months from start of Eylea treatment or until it is no longer possible (e.g. lost to follow-up). In total, 480 patients will be recruited. For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visit and final visit, either by routine clinical visits (as per investigators routine practice).

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - Diagnosis of NVG
    - Patients who have received IVT-AFL treatment according to Japanese labeling.
  • - Patients who are contraindicated based on approved label
    - Diagnosis of other indication

Trial summary

Enrollment Goal
480
Trial Dates
November 2020 - June 2028
Phase
N/A
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, Japan

Primary Outcome

  • The number of participants with adverse events (AEs)
    date_rangeTime Frame:
    Up to 6 months

Secondary Outcome

  • Intraocular Pressure (IOP) value after study drug administration
    In case of transient and/or persistent IOP elevation
    date_rangeTime Frame:
    Up to 6 months
  • Mean changes in Visual Acuity
    date_rangeTime Frame:
    Up to 6 months
  • Proportion of participants with improvement of anterior neovascularization
    date_rangeTime Frame:
    Up to 6 months

Trial design

Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A