Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090 (FIREFLEYE next)

Bayer

Status and phase: Completed; Phase 3

Conditions: Retinopathy of Prematurity (ROP)

Treatments: Procedure: Laser photocoagulation; Drug: Eylea (Aflibercept, BAY86-5321)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04015180

2018-003180-54 (EudraCT Number)

20275

2023-504207-89-00 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: Under 13 months old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Aflibercept arm

Experimental group

Description:

No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.

Treatment:

Drug: Eylea (Aflibercept, BAY86-5321)

Laser photocoagulation arm

Active Comparator group

Description:

No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.

Treatment:

Procedure: Laser photocoagulation