Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)

NCT04519619 | Recruiting

• 1 other identifier: 21220
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Neovascular Glaucoma

Outcome Measures

Primary Outcomes (1)

• The number of participants with adverse events (AEs)

  Up to 6 months

Secondary Outcomes (3)

• Intraocular Pressure (IOP) value after study drug administration

  Up to 6 months

• Mean changes in Visual Acuity

  Up to 6 months

• Proportion of participants with improvement of anterior neovascularization

  Up to 6 months

Study Arms (1)

Aflibercept (Eylea, BAY86-5321)

Decision of Eylea treatment is made by attending investigators according to the Japanese Package Insert

Drug: Aflibercept (Eylea, BAY86-5321)

Interventions

Aflibercept (Eylea, BAY86-5321) DRUG

Administration by intravitreal injection

Aflibercept (Eylea, BAY86-5321)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with a diagnosis of NVG will be enrolled after the decision for treatment with Aflibercept (AFL) has been made by the investigator. Participants who have been prescribed AFL for a medically appropriate use will be eligible to be enrolled. Indications and contraindications according to the local market authorization should be carefully considered.

You may qualify if:

• Diagnosis of NVG
• Patients who have received IVT-AFL treatment according to Japanese labeling.

You may not qualify if:

• Patients who are contraindicated based on approved label
• Diagnosis of other indication

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Japan

RECRUITING

MeSH Terms

Conditions

Glaucoma, Neovascular

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 19, 2020
• Study Start: November 27, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)