check_circleStudy Completed
Retinopathy of prematurity (ROP)
Bayer Identifier:
20090
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Aflibercept for retinopathy of prematurity – intravitreal injection versus laser therapy
Trial purpose
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.
Key Participants Requirements
Sex
AllAge
NaN - 32 WeeksTrial summary
Enrollment Goal
113Trial Dates
September 2019 - February 2021Phase
Phase 3Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hacettepe Universitesi Tip Fakultesi | Ankara, 06100, Turkey |
Completed | Baskent Universitesi Tip Fakultesi Hastanesi | Ankara, 06490, Turkey |
Completed | Eskisehir Osmangazi Universitesi Tip Fakultesi | Eskisehir, 26480, Turkey |
Withdrawn | Hospital of LT University of Health Sciences Kaunas Clinics | Kaunas, LT-50161, Lithuania |
Completed | Saglik Bilimleri Universitesi Antalya EA Hastanesi | Antalya, 07100, Turkey |
Withdrawn | A.O.U.I. Verona | Verona, 37126, Italy |
Completed | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma, 00168, Italy |
Completed | IRCCS Ospedale Pediatrico Bambino Gesù | Roma, 00165, Italy |
Completed | A.O. di Perugia | Perugia, 06129, Italy |
Completed | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano, 20122, Italy |
Withdrawn | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | S.B.U. Adana Sehir Egitim ve Arastirma Hastanesi | Adana, 4522, Turkey |
Completed | Gazi Universitesi Tip Fakultesi | Ankara, 06500, Turkey |
Withdrawn | Hospital de Sant Joan de Déu | Esplugues de LLobregat, 08950, Spain |
Completed | Hospital Regional de Málaga | Málaga, 29011, Spain |
Withdrawn | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | Kepler Universitätsklinikum Campus III | Linz, 4021, Austria |
Completed | Samsung Medical Center | Seoul, 06351, Korea, Republic Of |
Completed | Asan Medical Center | Seoul, 05505, Korea, Republic Of |
Completed | Soon Chun Hyang University Cheonan Hospital | Cheonan-si, Korea, Republic Of |
Withdrawn | Klinikum Klagenfurt am Wörthersee | Klagenfurt, 9020, Austria |
Completed | Queen Mary Hospital | Hong Kong, Hong Kong |
Completed | Kaplan Medical Center | Rehovot, 7661041, Israel |
Withdrawn | Rambam Health Corporation | Haifa, 3109601, Israel |
Withdrawn | Acibadem Saglik Hizmetleri ve Tic. A.S | Istanbul, 34140, Turkey |
Withdrawn | Inselspital Universitätsspital Bern | Bern, 3010, Switzerland |
Completed | Acibadem City Clinic Multiprofile Hospital for Active Treatm | Sofia, 1407, Bulgaria |
Completed | UMHAT Sveti Georgi | Plovdiv, 4002, Bulgaria |
Completed | II SOGHAT Sheinovo | Sofia, 1504, Bulgaria |
Completed | SHOGAT Prof Dimitar Stamatov | Varna, 9000, Bulgaria |
Withdrawn | Universitätsklinikum Greifswald | Greifswald, 17475, Germany |
Withdrawn | Augenzentrum am St. Franziskus-Hospital | Münster, 48145, Germany |
Withdrawn | Universitätsklinikum Köln | Köln, 50924, Germany |
Withdrawn | Universitätsklinikum Carl Gustav Carus Dresden | Dresden, 01307, Germany |
Withdrawn | Medizinische Einrichtungen der Universität Bonn | Bonn, 53105, Germany |
Completed | Hospital Prof. Dr. Fernando Fonseca | Amadora, 2720-276, Portugal |
Withdrawn | Hospital Beatriz Angelo | Loures, 2674-514, Portugal |
Completed | CHLO - Hospital Sao Francisco Xavier | Lisboa, 1449-005, Portugal |
Withdrawn | Clalit Health Services Schneider Children's Medical Center | Petach Tikva, 4920235, Israel |
Withdrawn | Luzerner Kantonsspital | Luzern, 6000, Switzerland |
Withdrawn | Eberhard-Karls-Universität Tübingen | Tübingen, 72076, Germany |
Withdrawn | Manchester Eye Hospital | Manchester, M13 9WH, United Kingdom |
Completed | Hospital Universitario "La Paz" | Madrid, 28046, Spain |
Completed | Hospital Universitario 12 de Octubre | Madrid, 28041, Spain |
Withdrawn | Hospital Universitari Son Espases | Palma de Mallorca, 07120, Spain |
Withdrawn | Hospital for Sick Children | Toronto, M5G 1X8, Canada |
Completed | AZ St-Jan Brugge Oostende AV | BRUGGE, 8000, Belgium |
Completed | Vseobecna fakultni nemocnice v Praze | Praha 2, 12808, Czechia |
Completed | Fakultni nemocnice Ostrava | Ostrava, 708 52, Czechia |
Withdrawn | Hadassah University Hospital Mount Scopus | Jerusalem, 9124001, Israel |
Withdrawn | Tel-Aviv Sourasky Medical Center | Tel Aviv, 6423906, Israel |
Withdrawn | Hospital Garcia de Orta | Almada, 2801-951, Portugal |
Completed | EKBC, Uj Szent Janos Korhaz es Szakrendelo | Budapest, 1125, Hungary |
Withdrawn | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Completed | UNIFESP/EPM | Sao Paulo, 04023-061, Brazil |
Withdrawn | Hospital Municipal Vila Santa Catarina | São Paulo, 04377-038, Brazil |
Completed | FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo" | Moscow, 119620, Russian Federation |
Withdrawn | FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov | Moscow, 127486, Russian Federation |
Completed | FSAI NMRC IRTC "Eye Microsurgery", Kaluga’s Branch | Kaluga, 248007, Russian Federation |
Completed | Pediatric Medical University | Saint-Petersburg, 194100, Russian Federation |
Completed | City Children Hospital ¿1 | Saint-Petersburg, 198205, Russian Federation |
Completed | Narodny ustav detskych chorob | Bratislava, 833 41, Slovakia |
Completed | MI"Odesa Regional Children's Clinical Hospital" | Odesa, 65031, Ukraine |
Withdrawn | National Pediatric Specialized Hospital "Okhmatdyt" | Kyiv, 01135, Ukraine |
Completed | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung, 80756, Taiwan |
Withdrawn | Chang Gung Memorial Hospital at Linkou | Taoyuan, 333423, Taiwan |
Completed | Mackay Memorial Hospital | Taipei, 10449, Taiwan |
Withdrawn | Tallinn Children´s Hospital | Tallinn, 13419, Estonia |
Withdrawn | Children's Clinical University Hospital | Riga, LV1004, Latvia |
Completed | Ginekologiczno-Polozniczy SK UM im. K. Marcinkowskiego | Poznan, 60-535, Poland |
Withdrawn | Hospital de Niños Sor María Ludovica | La Plata, 1900, Argentina |
Withdrawn | Hospital Maternal Nuestra Señora del Pilar | Pilar, Argentina |
Withdrawn | Inst. de Mater. y Gineco. Nuestra Señora de las Mercedes | San MIguel de Tucumán, Argentina |
Completed | Hospital Público Descentralizado "Dr. Guillermo Rawson" | San Juan, 5400, Argentina |
Withdrawn | Sanatorio Argentino | San Juan, J5400ANI, Argentina |
Completed | Russian National Scientific Medical University | Moscow, 117997, Russian Federation |
Completed | Sahlgrenska Universitetssjukhuset | Göteborg, Sweden |
Withdrawn | Lunds Universitetssjukhus | Lund, 221 85, Sweden |
Withdrawn | S:t Eriks Ögonsjukhus | Stockholm, 112 82, Sweden |
Completed | P & A KYRIAKOU Children's Hospital | Athens, 11527, Greece |
Completed | University General Hospital of Ioannina | Ioannina, 45500, Greece |
Completed | Papageorgiou General Hospital of Thessaloniki | Thessaloniki, 56403, Greece |
Withdrawn | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Completed | Birmingham Womens Hospital | Birmingham, B15 2TG, United Kingdom |
Withdrawn | Sapporo City General Hospital | Sapporo, 060-8604, Japan |
Completed | Fukushima Medical University Hospital | Fukushima, 960-1295, Japan |
Completed | Saitama Children's Medical Center | Saitama, 330-8777, Japan |
Completed | Tokyo Metropolitan Bokutoh Hospital | Sumida-ku, 130-8575, Japan |
Completed | Tokyo Metropolitan Ohtsuka Hospital | Toshima-ku, 170-8476, Japan |
Withdrawn | Tokyo Women's Medical University Yachiyo Medical Center | Yachiyo, 276-8524, Japan |
Withdrawn | National Center for Child Health and Development | Setagaya, 157-8535, Japan |
Withdrawn | Toho University Omori Medical Center | Ota-ku, 143-8541, Japan |
Completed | Tokyo Metropolitan Children's Medical Center | Fuchu, 183-8561, Japan |
Withdrawn | Yokohama City University Medical Center | Yokohama, 232-0024, Japan |
Withdrawn | Hamamatsu University Hospital | Hamamatsu, 431-3192, Japan |
Withdrawn | Nagoya University Hospital | Nagoya, 466-8560, Japan |
Withdrawn | Shiga University of Medical Science Hospital | Otsu, 520-2192, Japan |
Completed | Fukuoka University Hospital | Fukuoka, 814-0180, Japan |
Completed | Kyushu University Hospital | Fukuoka, 812-8582, Japan |
Completed | Kurume University Hospital | Kurume, 830-0011, Japan |
Completed | University of Occupational and Environmental Health | Kitakyushu, 807-8556, Japan |
Completed | Okinawa Prefectural Nanbu Medical Center and Children's MC | Shimajiri-gun, 901-1193, Japan |
Withdrawn | Showa University East Hospital | Shinagawa-ku, 142-0054, Japan |
Withdrawn | Fujita Health University Hospital | Toyoake, 470-1192, Japan |
Withdrawn | Hiroshima City Hiroshima Citizens Hospital | Hiroshima, 730-8518, Japan |
Withdrawn | Nara Medical University Hospital | Kashihara, 634-8522, Japan |
Withdrawn | Juntendo University Urayasu Hospital | Urayasu, 279-0021, Japan |
Completed | Showa University Hospital | Shinagawa, 142-8666, Japan |
Withdrawn | IWK Health Centre | Halifax, B3K 6R8, Canada |
Completed | Maxima Medisch Centrum, locatie Veldhoven | VELDHOVEN, 5504 DB, Netherlands |
Withdrawn | Karolinska Universitetssjukhuset Huddinge Stockholm | Stockholm, S-141 86, Sweden |
Withdrawn | Shamir Medical Center (Assaf Harofeh) | Zerifin, 6093000, Israel |
Withdrawn | CHUP - Hospital Santo Antonio | Porto, 4099-001, Portugal |
Withdrawn | ULSM - Hospital Pedro Hispano | Matosinhos, 4464-513, Portugal |
Completed | Hospital das Clínicas de Botucatu - UNESP Botucatu | Botucatu, 18618 970, Brazil |
Completed | Hospital Kuala Lumpur | Kuala Lumpur, 50586, Malaysia |
Withdrawn | University Hospital Kebangsaan Malaysia | Kuala Lumpur, 56000, Malaysia |
Withdrawn | Hopital Necker les enfants malades - Paris | PARIS, 75015, France |
Withdrawn | Hôpital Pellegrin - Bordeaux | BORDEAUX, 33076, France |
Withdrawn | Hôpital Arnaud de Villeneuve - Montpellier | MONTPELLIER, 34059, France |
Withdrawn | Fondation A. de Rotschild - Paris | PARIS CEDEX 19, 75940, France |
Withdrawn | Municipal Clinical Emergency Hospital of Timisoara | Timisoara, 300172, Romania |
Completed | Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda" | Iasi, 700038, Romania |
Completed | Clinical Emergency County Hospital | Cluj-Napoca, 400006, Romania |
Withdrawn | Hospital de Clínicas de Porto Alegre | Porto Alegre, Brazil |
Completed | KK Women's and Children's Hospital | Singapore, 229899, Singapore |
Withdrawn | Vivantes Klinikum Neukölln | Berlin, 12351, Germany |
Completed | Many Locations | Many Locations, Argentina |
Completed | Many Locations | Many Locations, Austria |
Completed | Many Locations | Many Locations, Belgium |
Completed | Many Locations | Many Locations, Bulgaria |
Completed | Many Locations | Many Locations, Brazil |
Withdrawn | Many Locations | Many Locations, Canada |
Withdrawn | Many Locations | Many Locations, Switzerland |
Completed | Many Locations | Many Locations, Czechia |
Withdrawn | Many Locations | Many Locations, Germany |
Withdrawn | Many Locations | Many Locations, Estonia |
Completed | Many Locations | Many Locations, Spain |
Withdrawn | Many Locations | Many Locations, France |
Completed | Many Locations | Many Locations, United Kingdom |
Completed | Many Locations | Many Locations, Greece |
Completed | Many Locations | Many Locations, Hong Kong |
Completed | Many Locations | Many Locations, Hungary |
Completed | Many Locations | Many Locations, Israel |
Completed | Many Locations | Many Locations, Italy |
Completed | Many Locations | Many Locations, Japan |
Completed | Many Locations | Many Locations, Korea, Republic Of |
Withdrawn | Many Locations | Many Locations, Lithuania |
Withdrawn | Many Locations | Many Locations, Latvia |
Completed | Many Locations | Many Locations, Malaysia |
Completed | Many Locations | Many Locations, Netherlands |
Completed | Many Locations | Many Locations, Poland |
Completed | Many Locations | Many Locations, Portugal |
Completed | Many Locations | Many Locations, Romania |
Completed | Many Locations | Many Locations, Russian Federation |
Completed | Many Locations | Many Locations, Sweden |
Completed | Many Locations | Many Locations, Singapore |
Completed | Many Locations | Many Locations, Slovakia |
Completed | Many Locations | Many Locations, Turkey |
Completed | Many Locations | Many Locations, Taiwan |
Completed | Many Locations | Many Locations, Ukraine |
Primary Outcome
- Proportion of participants with absence of active ROP and unfavorable structural outcomesActive ROP was defined as ROP requiring treatment. Unfavorable structural outcomes included retinal detachment, macular dragging, macular fold, or retrolental opacity.date_rangeTime Frame:At 24 weeks after starting study treatment
Secondary Outcome
- Proportion of participants requiring intervention with a second treatment modalityA second treatment modality for ROP was either rescue treatment or any other surgical or nonsurgical treatment for ROP (e.g. IVT anti-VEGF injection, ablative laser therapy, cryotherapy, or vitrectomy) captured as concomitant medication or surgery after study start.date_rangeTime Frame:From baseline (treatment) up to week 24.
- Proportion of participants with recurrence of ROPParticipants with recurrence of ROP were defined as subjects requiring re-treatment or rescue treatment after in the past the absence of treatment-requiring active ROP had been confirmed by the investigator.date_rangeTime Frame:From baseline (treatment) up to week 24.
- Exploration of ROP activity scale proposed by the International Neonatal ConsortiumEyes were evaluated for change in ROP activity scale proposed by the International Neonatal Consortium (2018). ROP Activity Scale value range is from 0 to 22. Value 0 to 7 are considered mild, 8 to 12 are moderate, and 13 to 22 are severe. Value 0 means the best and value 22 means the worst. Eyes evaluation was done at baseline and each visit.date_rangeTime Frame:From baseline (treatment) up to week 24.
- Percentage of participants with ocular Treatment-emergent Adverse Events (TEAEs)A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that was observed or reported after the first and not later than 30 days after the last administration of study treatment. Participants treated after week 21 were followed-up for adverse events up to week 28. Ocular TEAEs in treated eyes only were reporteddate_rangeTime Frame:From baseline (treatment) up to week 24
- Percentage of participants with ocular Serious Adverse Events (SAEs)Participants treated after week 21 were followed-up for adverse events up to week 28. Ocular SAEs in treated eyes only were reported.date_rangeTime Frame:From baseline (treatment) up to week 24
- Percentage of participants with systemic TEAEsA treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that was observed or reported after the first and not later than 30 days after the last administration of study treatment. Participants treated after week 21 were followed-up for adverse events up to week 28. Systemic TEAEs only were reported.date_rangeTime Frame:From baseline (treatment) up to week 24
- Percentage of participants with systemic SAEsParticipants treated after week 21 were followed-up for adverse events up to week 28. Systemic SAEs only were reported.date_rangeTime Frame:From baseline (treatment) up to week 24
- Concentrations of free aflibercept in plasmaBlood samples for determination of aflibercept concentrations in plasma were collected in the aflibercept 0.4 mg arm at Day 1 (within 24 hours after injection), and at weeks 2 and 4, and if feasible also at weeks 8, 12 and 24. Statistics for week 8, 12, 24 not calculated as > 1/3 of the concentrations were below the lower limit of quantification. Free Aflibercept Concentrations in Plasma were only measured in the Aflibercept 0.4 mg treatment arm.date_rangeTime Frame:From Day 1 up to week 24.
- Number of participants with anti-drug antibodies (ADA)Immunogenicity was characterized by anti-drug antibody (ADA) responses in patients in the aflibercept 0.4 mg arm. Serum samples were taken at baseline prior to the injection and at 12 weeks after injection. ADA titers were summarized for 3 categories: Low (titer <1,000); Moderate (1,000 ≤ titer ≤ 10,000); High (titer >10,000). ADA in serum were only measured in the Aflibercept 0.4 mg treatment arm.date_rangeTime Frame:Baseline (treatment) and 12 weeks after aflibercept injection
- Number of participants with potential neutralizing antibodies (NAb)NAb status was evaluated for the samples that were positive in the ADA assay and had sufficient volume to analyze. NAb were only measured in participants with positive ADA in the Aflibercept 0.4 mg treatment armdate_rangeTime Frame:At 12 weeks after aflibercept injection
- Number of aflibercept administrationsTotal number of injections in both eyes.date_rangeTime Frame:From baseline (treatment) up to week 24.
- Number of laser treatmentsTotal number of laser treatment in both eyes. If multiple sessions of laser treatment were necessary within 1 week from baseline, they were counted as a single treatment.date_rangeTime Frame:From baseline (treatment) up to week 24.
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2