Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04015180
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity (ROP) Drug: Eylea (Aflibercept, BAY86-5321) Procedure: Laser photocoagulation Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Extension Study to Evaluate the Long-term Outcomes of Subjects Who Received Treatment for Retinopathy of Prematurity in Study 20090
Estimated Study Start Date : March 4, 2020
Estimated Primary Completion Date : May 15, 2025
Estimated Study Completion Date : May 15, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aflibercept arm
No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
Drug: Eylea (Aflibercept, BAY86-5321)
Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.

Active Comparator: Laser photocoagulation arm
No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
Procedure: Laser photocoagulation
Treatment administered in 20090. Transpupillary conventional laser ablative therapy




Primary Outcome Measures :
  1. Binocular best-corrected visual acuity in Snellen equivalent [ Time Frame: At 5 years of age. ]
  2. Proportion of subjects with ocular AEs and SAEs [ Time Frame: Up to 5 years of age. ]
    AE: adverse event SAE: serious adverse event

  3. Proportion of subjects with systemic AEs and SAEs [ Time Frame: Up to 5 years of age. ]

Secondary Outcome Measures :
  1. Proportion of subjects developing unfavorable ocular structural outcome [ Time Frame: At 1,3 and 5 years of age. ]

    Unfavorable ocular structural outcome include:

    retinal detachment, macular dragging, macular fold, retrolental opacity


  2. Proportion of subjects with absence of active ROP [ Time Frame: At 1 year of age. ]
  3. Proportion of subjects with unfavorable structural outcomes [ Time Frame: At 1 year of age. ]
  4. Best-corrected visual acuity in each eye [ Time Frame: At 3 and 5 years of age. ]
  5. Refractive spherical equivalent in each eye [ Time Frame: At 3 and 5 years of age ]
  6. Neurodevelopmental outcomes using Bayley-III [ Time Frame: At 2 years of age ]
    Bayley-III: Bayley Scales of Infant and Toddler Development, third Edition. The assessment at 2 years of age is mandatory.

  7. Neurodevelopmental outcomes using WPPSI-IV [ Time Frame: At 5 years of age ]
    WPPSI-IV: Wechsler Preschool and Primary Scale of Intelligence, fourth Edition. The assessment at 5 years is mandatory. In cases where the WPSSI-IV cannot be used, the Differential Ability Scales II (DAS-II) may be used as an alternative.

  8. Proportion of subjects with recurrence of ROP [ Time Frame: At 3 and 5 years of age. ]
  9. Proportion of subjects requiring treatment for ROP [ Time Frame: Up to 5 years of age. ]
  10. Proportion of subjects requiring ophthalmological treatment [ Time Frame: Up to 5 years of age. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015180


Contacts
Layout table for location contacts
Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

  Show 116 Study Locations
Sponsors and Collaborators
Bayer

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04015180     History of Changes
Other Study ID Numbers: 20275
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Retinopathy of Prematurity
Premature Birth
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases