Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090
- Conditions
- Retinopathy of Prematurity (ROP)
- Interventions
- Drug: Eylea (Aflibercept, BAY86-5321)Procedure: Laser photocoagulation
- Registration Number
- NCT04015180
- Lead Sponsor
- Bayer
- Brief Summary
This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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
- Subject has a condition preventing participation in the study, or performance of study procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aflibercept arm Eylea (Aflibercept, BAY86-5321) No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090. Laser photocoagulation arm Laser photocoagulation No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
- Primary Outcome Measures
Name Time Method Proportion of subjects with systemic AEs and SAEs Up to 5 years of age. Proportion of subjects with ocular AEs and SAEs Up to 5 years of age. AE: adverse event SAE: serious adverse event
Binocular best-corrected visual acuity in Snellen equivalent At 5 years of age.
- Secondary Outcome Measures
Name Time Method Proportion of subjects with absence of active ROP and unfavorable structural outcomes At 1 year of age. Refractive spherical equivalent in each eye At 3 and 5 years of age Proportion of subjects requiring ophthalmological treatment Up to 5 years of age. Neurodevelopmental outcomes using VABS-II At 2 and 5 years of age VABS-II: Vineland Adaptive Behavior Scales, Second Edition Expanded Interview will be included, which includes 4 areas: Communication, Daily Living skills, Socialization and Motor Skills. It is recommended to be assessed at 2, 3, 4 and 5 years of age. The assessments at 2 years and 5 years of age are mandatory.
Neurodevelopmental outcomes using BSID-III At 2 years of age BSID-III: The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is a standard series of tests that will assess the development of children in 3 areas: cognition, language, and motor skills. It is recommended to be assessed at screening, 1 year and 2 years of age. The assessment at 2 years of age is mandatory.
Proportion of subjects developing unfavorable ocular structural outcome At 1,3 and 5 years of age. Unfavorable ocular structural outcome include:
retinal detachment, macular dragging, macular fold, retrolental opacityBest-corrected visual acuity in each eye At 3 and 5 years of age. Neurodevelopmental outcomes using WPPSI-IV At 5 years of age WPPSI-IV: The Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition is designed to assess development of older children and is recommended to be performed at 3, 4 and 5 years of age. The assessment at 5 years of age is mandatory. In cases where the WPSSI-IV cannot be used, the Differential Ability Scales II (DAS-II) may be used as an alternative.
Proportion of subjects with recurrence of ROP At 3 and 5 years of age. Proportion of subjects requiring treatment for ROP Up to 5 years of age.
Trial Locations
- Locations (55)
Hospital Público Descentralizado "Dr. Guillermo Rawson"
🇦🇷San Juan, Argentina
AZ Sint Jan Brugge - Ophthalmology
🇧🇪Brugge, Belgium
Hospital das Clínicas de Botucatu - UNESP Botucatu
🇧🇷Botucatu, Sao Paulo, Brazil
Unifesp/Epm
🇧🇷São Paulo, Sao Paulo, Brazil
UMHAT Sveti Georgi
🇧🇬Plovdiv, Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatm
🇧🇬Sofia, Bulgaria
Spec. Hospital of Ophthalm. for Active Treatment Visus
🇧🇬Sofia, Bulgaria
Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
🇧🇬Varna, Bulgaria
Fakultni nemocnice Ostrava
🇨🇿Ostrava, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Children's Hospital of Athens P&A Kyriakou
🇬🇷Athens, Greece
University General Hospital of Ioannina
🇬🇷Ioannina, Greece
General Hospital of Thessaloniki Papageorgiou
🇬🇷Thessaloniki, Greece
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és Szakrendelo
🇭🇺Budapest, Hungary
Kaplan Medical Center
🇮🇱Rehovot, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oculistica
🇮🇹Roma, Lazio, Italy
Ospedale Pediatrico Bambino Gesù - Oculistica
🇮🇹Roma, Lazio, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Oculistica
🇮🇹Milano, Lombardia, Italy
A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Oculistica
🇮🇹Perugia, Umbria, Italy
Hospital of the University of Occupational and Environmental Health, Japan
🇯🇵Kitakyushu, Fukuoka, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Okinawa Prefectural Nanbu Medical Center and Children's MC
🇯🇵Shimajiri-gun, Okinawa, Japan
Kindai University Hospital
🇯🇵Osakasayama-shi, Osaka, Japan
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center
🇯🇵Fuchu, Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital
🇯🇵Sumida-ku, Tokyo, Japan
Tokyo Metropolitan Ohtsuka Hospital
🇯🇵Toshima-ku, Tokyo, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Soon Chun Hyang University Cheonan Hospital
🇰🇷Cheonan, Chungcheongnamdo, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
Maxima Medisch Centrum, locatie Veldhoven
🇳🇱Veldhoven, Netherlands
Hospital Prof. Dr. Fernando Fonseca
🇵🇹Amadora, Lisboa, Portugal
Centro Hospitalar de Lisboa Ocidental | Clinical Research Department
🇵🇹Lisboa, Portugal
Clinical Emergency County Hospital
🇷🇴Cluj-Napoca, Cluj, Romania
Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"
🇷🇴Iasi, Romania
FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch
🇷🇺Kaluga, Russian Federation
FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo"
🇷🇺Moscow, Russian Federation
City Children Hospital ?1
🇷🇺Saint-Petersburg, Russian Federation
KK Women's and Children's Hospital
🇸🇬Singapore, Singapore
Narodny ustav detskych chorob
🇸🇰Bratislava, Slovakia
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital la Paz - oftalmologia
🇪🇸Madrid, Spain
Hospital Regional de Malaga | Oftalmologia
🇪🇸Málaga, Spain
Sahlgrenska Universitetssjukhuset
🇸🇪Göteborg, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung City, Kaohsiung, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Hacettepe Universitesi Tip Fakultesi
🇹🇷Ankara, Turkey
Gazi Universitesi Tip Fakultesi
🇹🇷Ankara, Turkey
Saglik Bilimleri Universitesi Antalya EA Hastanesi
🇹🇷Antalya, Turkey
Eskisehir Osmangazi Universitesi Tip Fakultesi
🇹🇷Eskisehir, Turkey
Adana Sehir Egitim ve Arastirma Hastanesi
🇹🇷Yüregir, Turkey
The Filatov Institute of Eye Diseases and Tissue Therapy
🇺🇦Odesa, Ukraine
Birmingham Womens Hospital
🇬🇧Birmingham, United Kingdom