AFLIBERCEPT for Retinopathy of prematurity (ROP)

Inclusion criteria

• {"criterion_text":"- Patient was treated in study VGFTe-ROP-1920"}
• {"criterion_text":"- Age <13 months of chronological age"}
• {"criterion_text":"- Signed informed consent from parent(s)/legal guardian(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol"}

Exclusion criteria

• {"criterion_text":"- 1.\tPatient has a condition preventing participation in the study, or performance of study procedures. \tNOTE: Other Inclusion/Exclusion criteria may apply"}

Primary endpoints

• {"endpoint_text":"- Binocular best-corrected visual acuity (BCVA)","definition_or_measurement_approach":"Evaluate binocular visual acuity at the end of the study (BCVA)."}
• {"endpoint_text":"- Proportion of Patients with Adverse Events","definition_or_measurement_approach":"Proportion of patients experiencing adverse events as recorded during the study."}
• {"endpoint_text":"- Proportion of Patients with Serious Adverse Events","definition_or_measurement_approach":"Proportion of patients experiencing serious adverse events as recorded during the study."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients developing unfavorable ocular structural outcome","definition_or_measurement_approach":"Proportion of patients with unfavorable ocular structural outcomes as assessed by ophthalmic examinations."}
• {"endpoint_text":"- BCVA in each eye","definition_or_measurement_approach":"Best-corrected visual acuity measured separately in each eye."}
• {"endpoint_text":"- Refractive spherical equivalent in each eye","definition_or_measurement_approach":"Measurement of refractive spherical equivalent in each eye using standard refraction methods."}
• {"endpoint_text":"- Neurodevelopmental outcomes using BSID-III","definition_or_measurement_approach":"Neurodevelopmental assessment using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)."}
• {"endpoint_text":"- Neurodevelopmental outcomes using WPPSI-IV","definition_or_measurement_approach":"Neurodevelopmental assessment using the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV)."}
• {"endpoint_text":"- Neurodevelopmental outcomes using VABS-II","definition_or_measurement_approach":"Adaptive behaviour assessment using the Vineland Adaptive Behavior Scales, Second Edition (VABS-II)."}
• {"endpoint_text":"- Proportion of patients with recurrence of ROP","definition_or_measurement_approach":"Proportion of patients with documented recurrence of retinopathy of prematurity (ROP)."}
• {"endpoint_text":"- Proportion of patients requiring treatment for ROP","definition_or_measurement_approach":"Proportion of patients who require additional treatment for ROP during the study period."}

Romania

Earliest CTIS Part Ii Submission Date

29-08-2024

Latest Decision Or Authorization Date

07-10-2024

Processing Time Days

39

Number Of Sites

1

Number Of Participants

2

Bulgaria

Earliest CTIS Part Ii Submission Date

29-08-2024

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

595

Number Of Sites

2

Number Of Participants

5

Primary sponsor

Full Name

Regeneron Pharmaceuticals Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

sponsorDuties codes: [1,12,5,6]; contact: ingrid.jones@parexel.com

Name

Iqvia Pharma Inc.

Responsibilities

sponsorDuties codes: [6,7]; contact: anupama.muppaneni@quintiles.com

Name

Ercules Comunicazioni S.r.l.

Responsibilities

To create recruitment and retention materials; contact: lucina.tabasso@ercules.it

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: [1,12,5,6]; contact: ingrid.jones@parexel.com","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Ercules Comunicazioni S.r.l.","duties_or_roles":"sponsorDuties code: 15 (\"To create recruitment and retention materials\"); contact: lucina.tabasso@ercules.it","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Pharma Inc.","duties_or_roles":"sponsorDuties codes: [6,7]; contact: anupama.muppaneni@quintiles.com","organisation_type":"Pharmaceutical company"}