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Clinical Trials List

Protocol NumberBAY 86-5321 / 20275
Active

2020-03-15 - 2025-05-15

Phase III

Terminated3

ICD-10H35.89

Other specified retinal disorders

ICD-9362.89

Other retinal disorders

An extension study to evaluate the long-term outcomes of subjects who received treatment for retinopathy of prematurity in Study 20090

  • Trial Applicant

    BAYER TAIWAN COMPANY LTD.

  • Sponsor

    Bayer AG.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Wei-Chi WU

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 蔡翔翎

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Yu-Hung Lai Division of Ophthalmology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Condition/Disease

Retinopathy of Prematurity (ROP)

Objectives

This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.

Test Drug

Eylea

Active Ingredient

aflibercept

Dosage Form

Dosage

0.4 mg/0.01 mL

Endpoints

Binocular best-corrected visual acuity in Snellen equivalent
Proportion of subjects with ocular AEs and SAEs
Proportion of subjects with systemic AEs and SAEs

Inclution Criteria

Inclusion Criteria:

- Subject was treated in Study 20090
- Age less than 13 months of chronological age
- Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria

Exclusion Criteria:

- Subject has a condition preventing participation in the study, or performance of study procedures.

The Estimated Number of Participants

  • Taiwan

    3 participants

  • Global

    100 participants