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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBayer

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of NVG

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

Disqualifiers

Patients who are contraindicated based on approved label

Diagnosis of other indication

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Aflibercept (Eylea, BAY86-5321)

    Drug

    Administration by intravitreal injection

Treatment groups

480 Participants
are divided into 1 treatment group
Group A: Aflibercept (Eylea, BAY86-5321)1 intervention

Trial outcomes

Primary outcomes

1

The number of participants with adverse events (AEs)

Time frame
Up to 6 months

Secondary outcomes

1

Intraocular Pressure (IOP) value after study drug administration

In case of transient and/or persistent IOP elevation

Time frame
Up to 6 months
2

Mean changes in Visual Acuity

Time frame
Up to 6 months
3

Proportion of participants with improvement of anterior neovascularization

Time frame
Up to 6 months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Many locationsRecruiting Multiple LocationsJapanJapan

Sponsors and contacts

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