Extension study to evaluate the long-term outcomes of subjects in Study 20090

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225079

Enrollment

100

Registered

2020-02-19

Start date

2020-03-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of prematurity (ROP)

Interventions

investigational material(s) Generic name etc : BAY86-5321 INN of investigational material : aflibercept Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject was treated in Study 20090 2. Age less than 13 months of chronological age 3. 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: 1. Subject has a condition preventing participation in the study, or performance of study procedures

Design outcomes

Primary

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

Secondary

Measure	Time frame
safety efficacy 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 and unfavorable structural outcomes [ Time Frame: At 1 year of age. ] 3. Best-corrected visual acuity in each eye [ Time Frame: At 3 and 5 years of age. ] 4. Refractive spherical equivalent in each eye [ Time Frame: At 3 and 5 years of age ] 5. Neurodevelopmental outcomes using BSID-3 [ Time Frame: At 2 years of age ] BSID-3: The Bayley Scales of Infant and Toddler Development, Third Edition 6. Neurodevelopmental outcomes using WPPSI-4 [ Time Frame: At 5 years of age ] WPPSI-4: The Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition 7. Neurodevelopmental outcomes using VABS-2 [ Time Frame: At 2 and 5 years of age ] VABS-2: Vineland Adaptive Behavior Scales, Second Edition Expanded Interview 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. ]	—

Measure

Time frame

safety efficacy 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 and unfavorable structural outcomes [ Time Frame: At 1 year of age. ] 3. Best-corrected visual acuity in each eye [ Time Frame: At 3 and 5 years of age. ] 4. Refractive spherical equivalent in each eye [ Time Frame: At 3 and 5 years of age ] 5. Neurodevelopmental outcomes using BSID-3 [ Time Frame: At 2 years of age ] BSID-3: The Bayley Scales of Infant and Toddler Development, Third Edition 6. Neurodevelopmental outcomes using WPPSI-4 [ Time Frame: At 5 years of age ] WPPSI-4: The Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition 7. Neurodevelopmental outcomes using VABS-2 [ Time Frame: At 2 and 5 years of age ] VABS-2: Vineland Adaptive Behavior Scales, Second Edition Expanded Interview 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. ]

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Countries

Asia except Japan, Europe, Japan, North America, South America

Contacts

Public Contactcontact Dedicated

Bayer Yakuhin, Ltd.

byl_ct_contact@bayer.com+81-6-6133-6363

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026