---
title: Eylea Post Marketing Surveillance(PMS)
nct_id: NCT01783925
overall_status: COMPLETED
sponsor: Bayer
study_type: OBSERVATIONAL
primary_condition: Macular Degeneration
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01783925.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01783925"
ct_last_update_post_date: 2023-11-07
last_seen_at: "2026-05-12T06:49:17.114Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Eylea Post Marketing Surveillance(PMS)

**Official Title:** Eylea Post Marketing Surveillance

**NCT ID:** [NCT01783925](https://clinicaltrials.gov/study/NCT01783925)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 3206
- **Lead Sponsor:** Bayer
- **Collaborators:** Regeneron Pharmaceuticals
- **Conditions:** Macular Degeneration
- **Start Date:** 2014-04-29
- **Completion Date:** 2018-12-31
- **CT.gov Last Update:** 2023-11-07

## Brief Summary

The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients determined to start EYLEA treatment
* Patients who agree and sign informed consent
* Patients who receive EYLEA treatment for the first time
* Patients who meet one of the following

  * Patients diagnosed by physician as having neovascular (wet) age-related macular degeneration wAMD
  * Patients diagnosed by physician as having visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO)
  * Patients diagnosed as having visual impairment due to diabetic macular edema (DME)
  * Patients diagnosed as having visual impairment due to myopic choroidal neovascularization (mCNV)

Exclusion Criteria:

* Patients who have received anti-VEGF therapy within 90 days
* Patients who are contraindicated based on the approved product label

  * Ocular or periocular infection
  * Active severe intraocular inflammation
  * Known hypersensitivity to any ingredient of this drug
```

## Arms

- **Group 1**

## Interventions

- **Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)** (DRUG) — Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label.

## Primary Outcomes

- **Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)** _(time frame: 4 months)_

## Secondary Outcomes

- **Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart. [BCVA: Best Corrected Visual Acuity]** _(time frame: 4 months or 8 months)_
- **Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography]** _(time frame: 4 months or 8 months)_
- **Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography]** _(time frame: 4 months or 8 months)_
- **IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure]** _(time frame: 4 months or 8 months)_
- **Measurement of fundus lesion by fundoscopy** _(time frame: 4 months or 8 months)_
- **Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)** _(time frame: 8 months)_

## Locations (1)

- Many Locations, Multiple Locations, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.many locations|multiple locations||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01783925.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01783925*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*