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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002611-99 | EudraCT Number |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept arm | Experimental | Subjects randomized to aflibercept will receive a intravitreal (IVT) injection of Dose A aflibercept per eligible eye at baseline and, if needed, up to a defined number of additional injections in each eye. |
|
| Laser photocoagulation arm | Active Comparator | Subjects randomized to laser photocoagulation will receive treatment in each eligible eye at baseline. Retreatments may be administered if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eylea (Aflibercept, BAY86-5321) | Drug | Solution in a sterile glass vial, Dose A, IVT injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes | Active ROP was defined as ROP requiring treatment. Unfavorable structural outcomes included retinal detachment, macular dragging, macular fold, or retrolental opacity. | At 24 weeks after starting study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Requiring Intervention With a Second Treatment Modality | A 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. | From baseline (treatment) up to week 24. |
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Inclusion Criteria:
Gestational age at birth ≤ 32 weeks or birth weight ≤ 1500 g
Subjects with treatment-naïve ROP classified according to the International Classification for ROP in at least one eye as:
Weight at baseline (day of treatment) ≥ 800 g
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Argentina | ||||
| Hospital Público Descentralizado "Dr. Guillermo Rawson" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38200320 | Derived | Stahl A, Azuma N, Wu WC, Lepore D, Sukgen E, Nakanishi H, Mazela J, Leal S, Pieper A, Schlief S, Eissing T, Turner KC, Zhao A, Winkler J, Hochel J, Kofuncu E, Zimmermann T; FIREFLEYE Study Group. Systemic exposure to aflibercept after intravitreal injection in premature neonates with retinopathy of prematurity: results from the FIREFLEYE randomized phase 3 study. Eye (Lond). 2024 Jun;38(8):1444-1453. doi: 10.1038/s41433-023-02919-9. Epub 2024 Jan 10. | |
| 35881122 |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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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.
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121 participants were screened. 1 participant was a screen fail and 2 participants were withdrawn by parent/guardian. 118 participants were randomized, 75 participants were randomized to the aflibercept arm and 43 to the laser arm. 113 participants were treated, 5 participants randomized to the laser photocoagulation arm were withdrawn before receiving any study intervention.
Study was conducted at 64 centers in 27 countries or regions, between 25-SEP-2019 (first participant first visit) and 12-Feb-2021 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Aflibercept 0.4 mg | One intravitreal injection of aflibercept 0.4 mg (0.01 mL) per eligible eye at baseline (treatment), with up to 2 re-injections at the same single dose allowed for each eligible eye if required and interval since last aflibercept injection was 28 or more days. One or both eyes could be treated. |
| FG001 |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 23, 2020 | Feb 8, 2022 |
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| Laser photocoagulation | Procedure | Transpupillary conventional laser ablative therapy |
|
| Proportion of Participants With Recurrence of ROP | Participants 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. | From baseline (treatment) up to week 24. |
| Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium | Eyes 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. | 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 reported | 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. | From baseline (treatment) up to week 24 |
| Percentage of Participants With Systemic 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. Systemic TEAEs only were reported. | From baseline (treatment) up to week 24 |
| Percentage of Participants With Systemic SAEs | Participants treated after week 21 were followed-up for adverse events up to week 28. Systemic SAEs only were reported. | From baseline (treatment) up to week 24 |
| Concentrations of Free Aflibercept in Plasma | Blood 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. | 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. | 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 arm | At 12 weeks after aflibercept injection |
| Number of Aflibercept Administrations | Total number of injections in both eyes. | From baseline (treatment) up to week 24. |
| Number of Laser Treatments | Total 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. | From baseline (treatment) up to week 24. |
| San Juan |
| 5400 |
| Argentina |
| Kepler Universitätsklinikum Campus III | Linz | 4021 | Austria |
| Many Locations | Multiple Locations | Austria |
| AZ St-Jan Brugge Oostende AV | Bruges | 8000 | Belgium |
| Many Locations | Multiple Locations | Belgium |
| Hospital das Clínicas de Botucatu - UNESP Botucatu | Botucatu | São Paulo | 18618 970 | Brazil |
| Many Locations | Multiple Locations | Brazil |
| Unifesp/Epm | São Paulo | 04023-061 | Brazil |
| Many Locations | Multiple Locations | Bulgaria |
| UMHAT Sveti Georgi | Plovdiv | 4002 | Bulgaria |
| Acibadem City Clinic Multiprofile Hospital for Active Treatm | Sofia | 1407 | Bulgaria |
| II SOGHAT Sheinovo | Sofia | 1504 | Bulgaria |
| SHOGAT Prof Dimitar Stamatov | Varna | 9000 | Bulgaria |
| Many Locations | Multiple Locations | Czechia |
| Fakultni nemocnice Ostrava | Ostrava | 708 52 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 12808 | Czechia |
| P & A KYRIAKOU Children's Hospital | Athens | 11527 | Greece |
| University General Hospital of Ioannina | Ioannina | 45500 | Greece |
| Many Locations | Multiple Locations | Greece |
| Papageorgiou General Hospital of Thessaloniki | Thessaloniki | 56403 | Greece |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Many Locations | Multiple Locations | Hong Kong |
| EKBC, Uj Szent Janos Korhaz es Szakrendelo | Budapest | 1125 | Hungary |
| Many Locations | Multiple Locations | Hungary |
| Many Locations | Multiple Locations | Israel |
| Kaplan Medical Center | Rehovot | 7661041 | Israel |
| IRCCS Ospedale Pediatrico Bambino Gesù | Rome | Lazio | 00165 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Lazio | 00168 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Lombardy | 20122 | Italy |
| A.O. di Perugia | Perugia | Umbria | 06129 | Italy |
| Many Locations | Multiple Locations | Italy |
| University of Occupational and Environmental Health | Kitakyushu | Fukuoka | 807-8556 | Japan |
| Kurume University Hospital | Kurume | Fukuoka | 830-0011 | Japan |
| Okinawa Prefectural Nanbu Medical Center and Children's MC | Shimajiri-gun | Okinawa | 901-1193 | Japan |
| Tokyo Metropolitan Children's Medical Center | Fuchū | Tokyo | 183-8561 | Japan |
| Showa University Hospital | Shinagawa | Tokyo | 142-8666 | Japan |
| Tokyo Metropolitan Bokutoh Hospital | Sumida-ku | Tokyo | 130-8575 | Japan |
| Tokyo Metropolitan Ohtsuka Hospital | Toshima-ku | Tokyo | 170-8476 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Fukuoka University Hospital | Fukuoka | 814-0180 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960-1295 | Japan |
| Many Locations | Multiple Locations | Japan |
| Saitama Children's Medical Center | Saitama | 330-8777 | Japan |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Many Locations | Multiple Locations | Malaysia |
| Many Locations | Multiple Locations | Netherlands |
| Maxima Medisch Centrum, locatie Veldhoven | Veldhoven | 5504 DB | Netherlands |
| Many Locations | Multiple Locations | Poland |
| Ginekologiczno-Polozniczy SK UM im. K. Marcinkowskiego | Poznan | 60-535 | Poland |
| Hospital Prof. Dr. Fernando Fonseca | Amadora | Lisbon District | 2720-276 | Portugal |
| CHLO - Hospital Sao Francisco Xavier | Lisbon | 1449-005 | Portugal |
| Many Locations | Multiple Locations | Portugal |
| Clinical Emergency County Hospital | Cluj-Napoca | Cluj | 400006 | Romania |
| Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda" | Iași | 700038 | Romania |
| Many Locations | Multiple Locations | Romania |
| FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch | Kaluga | 248007 | Russia |
| Russian National Scientific Medical University | Moscow | 117997 | Russia |
| FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo" | Moscow | 119620 | Russia |
| Many Locations | Multiple Locations | Russia |
| Pediatric Medical University | Saint Petersburg | 194100 | Russia |
| City Children Hospital ¿1 | Saint Petersburg | 198205 | Russia |
| Many Locations | Multiple Locations | Singapore |
| KK Women's and Children's Hospital | Singapore | 229899 | Singapore |
| Narodny ustav detskych chorob | Bratislava | 833 41 | Slovakia |
| Many Locations | Multiple Locations | Slovakia |
| Soon Chun Hyang University Cheonan Hospital | Cheonan-si | Chungcheongnam-do | South Korea |
| Many Locations | Multiple Locations | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario "La Paz" | Madrid | 28046 | Spain |
| Hospital Regional de Málaga | Málaga | 29011 | Spain |
| Many Locations | Multiple Locations | Spain |
| Sahlgrenska Universitetssjukhuset | Gothenburg | Sweden |
| Many Locations | Multiple Locations | Sweden |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 80756 | Taiwan |
| Many Locations | Multiple Locations | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| S.B.U. Adana Sehir Egitim ve Arastirma Hastanesi | Adana | 4522 | Turkey (Türkiye) |
| Hacettepe Universitesi Tip Fakultesi | Ankara | 06100 | Turkey (Türkiye) |
| Baskent Universitesi Tip Fakultesi Hastanesi | Ankara | 06490 | Turkey (Türkiye) |
| Gazi Universitesi Tip Fakultesi | Ankara | 06500 | Turkey (Türkiye) |
| Saglik Bilimleri Universitesi Antalya EA Hastanesi | Antalya | 07100 | Turkey (Türkiye) |
| Eskisehir Osmangazi Universitesi Tip Fakultesi | Eskişehir | 26480 | Turkey (Türkiye) |
| Many Locations | Multiple Locations | Turkey (Türkiye) |
| Many Locations | Multiple Locations | Ukraine |
| MI"Odesa Regional Children's Clinical Hospital" | Odesa | 65031 | Ukraine |
| Birmingham Womens Hospital | Birmingham | B15 2TG | United Kingdom |
| Many Locations | Multiple Locations | United Kingdom |
| Derived |
| Stahl A, Sukgen EA, Wu WC, Lepore D, Nakanishi H, Mazela J, Moshfeghi DM, Vitti R, Athanikar A, Chu K, Iveli P, Zhao F, Schmelter T, Leal S, Kofuncu E, Azuma N; FIREFLEYE Study Group. Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial. JAMA. 2022 Jul 26;328(4):348-359. doi: 10.1001/jama.2022.10564. |
| Laser Photocoagulation |
Laser treatment to each eligible eye at baseline (treatment), with supplementary laser treatments allowed. Multiple sessions within one week from baseline were counted as a single treatment. One or both eyes could be treated. |
|
| SAF | The safety analysis set (SAF) included all participants who received any type of study treatment. |
|
| PKS | The pharmacokinetic analysis set (PKS) included all participants who received aflibercept treatment at the baseline visit and who had at least one nonmissing PK assessment following the first dose of study drug. |
|
| AAS | The anti-drug antibody (ADA) analysis set (AAS) included all participants who received aflibercept at baseline and had at least 1 nonmissing result in the ADA assay following the first study dose. |
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| COMPLETED |
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| NOT COMPLETED |
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SAF
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| ID | Title | Description |
|---|---|---|
| BG000 | Aflibercept 0.4 mg | One intravitreal injection of aflibercept 0.4 mg (0.01 mL) per eligible eye at baseline (treatment), with up to 2 re-injections at the same single dose allowed for each eligible eye if required and interval since last aflibercept injection was 28 or more days. One or both eyes could be treated. |
| BG001 | Laser Photocoagulation | Laser treatment to each eligible eye at baseline (treatment), with supplementary laser treatments allowed. Multiple sessions within one week from baseline were counted as a single treatment. One or both eyes could be treated. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Gestational age at birth | Mean | Standard Deviation | weeks |
| ||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| ROP classification by investigator | ROP (retinopathy of prematurity) classified by the investigator according to the International Classification for Retinopathy of Prematurity in at least one eye with one of the following retinal findings: Zone I, or Zone II, or AP(aggressive posterior)-ROP (Zone I, Zone II). Zone I is the innermost zone of the retina centered around the optic disc, surrounded by the more peripheral Zone II. AP-ROP is a rapidly progressive form of ROP, with posterior location, most commonly observed in Zone I, less common in posterior Zone II. AP-ROP, if untreated, usually progresses to retinal detachment. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes | Active ROP was defined as ROP requiring treatment. Unfavorable structural outcomes included retinal detachment, macular dragging, macular fold, or retrolental opacity. | Posted | Number | Proportion of participants | At 24 weeks after starting study treatment |
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| Secondary | Proportion of Participants Requiring Intervention With a Second Treatment Modality | A 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. | Posted | Number | Proportion of participants | From baseline (treatment) up to week 24. |
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| Secondary | Proportion of Participants With Recurrence of ROP | Participants 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. | Posted | Number | Proportion of participants | From baseline (treatment) up to week 24. |
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| Secondary | Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium | Eyes 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. | Posted | Mean | Standard Deviation | Scores on a scale | From baseline (treatment) up to week 24. |
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| Secondary | 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 reported | Posted | Number | Percentage of participants | From baseline (treatment) up to week 24 |
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| Secondary | 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. | Posted | Number | Percentage of participants | From baseline (treatment) up to week 24 |
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| Secondary | Percentage of Participants With Systemic 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. Systemic TEAEs only were reported. | Posted | Number | Percentage of participants | From baseline (treatment) up to week 24 |
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| Secondary | Percentage of Participants With Systemic SAEs | Participants treated after week 21 were followed-up for adverse events up to week 28. Systemic SAEs only were reported. | Posted | Number | Percentage of participants | From baseline (treatment) up to week 24 |
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| Secondary | Concentrations of Free Aflibercept in Plasma | Blood 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. | The outcome measure was analyzed based on pharmacokinetic analysis set (PKS). The PKS included all participants who received aflibercept treatment at the baseline visit and who had at least one nonmissing PK assessment following the first dose of study drug. | Posted | Mean | Standard Deviation | ng/mL | From Day 1 up to week 24. |
|
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| Secondary | 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. | Posted | Count of Participants | Participants | Baseline (treatment) and 12 weeks after aflibercept injection |
|
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| Secondary | 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 arm | Posted | Count of Participants | Participants | At 12 weeks after aflibercept injection |
|
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| Secondary | Number of Aflibercept Administrations | Total number of injections in both eyes. | Posted | Count of Participants | Participants | From baseline (treatment) up to week 24. |
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| Secondary | Number of Laser Treatments | Total 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. | Posted | Count of Participants | Participants | From baseline (treatment) up to week 24. |
|
|
After the first administration and not later than 30 days after the last administration of study treatment, up to 24 weeks.
Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aflibercept 0.4 mg | One intravitreal injection of aflibercept 0.4 mg (0.01 mL) per eligible eye at baseline (treatment), with up to 2 re-injections at the same single dose allowed for each eligible eye if required and interval since last aflibercept injection was 28 or more days. One or both eyes could be treated. | 3 | 75 | 9 | 75 | 53 | 75 |
| EG001 | Laser Photocoagulation | Laser treatment to each eligible eye at baseline (treatment), with supplementary laser treatments allowed. Multiple sessions within one week from baseline were counted as a single treatment. One or both eyes could be treated. | 0 | 38 | 10 | 38 | 23 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary valve stenosis | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Corneal oedema | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Retinopathy of prematurity | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Necrotising colitis | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (23.1) | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Infantile apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Ankyloglossia congenital | Congenital, familial and genetic disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Laryngomalacia | Congenital, familial and genetic disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Congenital arterial malformation | Congenital, familial and genetic disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Auditory disorder | Ear and labyrinth disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Adrenomegaly | Endocrine disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Conjunctival oedema | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Corneal oedema | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Iris adhesions | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Lenticular opacities | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Retinal vascular disorder | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Retinopathy of prematurity | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Swelling of eyelid | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Vitreous opacities | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Vitreoretinal traction syndrome | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Crying | General disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Bacterial disease carrier | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (23.1) | Non-systematic Assessment |
| |
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA (23.1) | Non-systematic Assessment |
| |
| Multiple use of single-use product | Injury, poisoning and procedural complications | MedDRA (23.1) | Non-systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Brain stem auditory evoked response abnormal | Investigations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Otoacoustic emissions test abnormal | Investigations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Extremity contracture | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Non-systematic Assessment |
| |
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Non-systematic Assessment |
| |
| Developmental coordination disorder | Nervous system disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Intraventricular haemorrhage neonatal | Nervous system disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Thalamus haemorrhage | Nervous system disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Neonatal seizure | Nervous system disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Chronic respiratory disease | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Non-systematic Assessment |
|
The disclosure restriction is that the PI has to ensure that the sponsor can review results communications at least 60 days prior to the planned public release.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2021 | Feb 8, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| Preterm newborn infants (gestational age < 37 wks) |
|
| Newborns (0-27 days) |
|
| Infants and toddlers (28 days-23 months) |
|
| Children (2-11 years) |
|
| Adolescents (12-17 years) |
|
| Adults (18-64 years) |
|
| From 65-84 years |
|
| 85 years and over |
|
| Male |
|
| Black or African American |
|
| Asian Indian |
|
| Chinese |
|
| Japanese |
|
| Korean |
|
| Asian: Other |
|
| American Indian or Alaska Native |
|
| Multiple |
|
| Zone II excluding AP-ROP |
|
| AP-ROP: Zone I |
|
| AP-ROP: Zone II |
|
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