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

• Sponsor: Bayer (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04519619
• Collaborator: (none)
• Enrollment: 480
• Location: 1
• Anticipated Duration (Months): 91.1
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Neovascular Glaucoma	Drug: Aflibercept (Eylea, BAY86-5321)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 480 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)
• Actual Study Start Date: Nov 27, 2020
• Anticipated Primary Completion Date: Jun 30, 2027
• Anticipated Study Completion Date: Jun 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Aflibercept (Eylea, BAY86-5321) Decision of Eylea treatment is made by attending investigators according to the Japanese Package Insert	Drug: Aflibercept (Eylea, BAY86-5321); Administration by intravitreal injection

Outcome Measures

Primary Outcome Measures

1. The number of participants with adverse events (AEs) [Up to 6 months]

Secondary Outcome Measures

1. Intraocular Pressure (IOP) value after study drug administration [Up to 6 months]

   In case of transient and/or persistent IOP elevation

2. Mean changes in Visual Acuity [Up to 6 months]

3. Proportion of participants with improvement of anterior neovascularization [Up to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of NVG

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

Exclusion Criteria:

• Patients who are contraindicated based on approved label

• Diagnosis of other indication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Many locations	Multiple Locations		Japan

Sponsors and Collaborators

• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT04519619
• Other Study ID Numbers: 21220
• First Posted: Aug 19, 2020
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Neovascular; Aflibercept

Study Results

No Results Posted as of Aug 18, 2022