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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003041-10 | EudraCT Number |
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The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).
The study consisted of a screening period (screening and randomization could occur up to 3 days before the administration of the first investigational treatment), followed by a treatment and follow-up period (Day 1 to Day 169).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 0.2 mg | Experimental | 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required |
|
| Ranibizumab 0.1 mg | Experimental | 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required |
|
| Laser therapy | Active Comparator | Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Administered as an intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 | To achieve this outcome, patients must fulfill all the following criteria, 1) survival, 2) no intervention with a second modality for ROP, 3) absence of active ROP and 4) absence of unfavorable structural outcome. Retinopathy of prematurity (ROP) is a pathologic process that occurs in the incompletely vascularized, developing retina of low birth-weight preterm neonates. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24 | Intervention for ROP in either eye at or before the 24-week assessment visit with a treatment modality other than the modality of the first study treatment. Only descriptive analysis done. | Week 24 |
| Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Loma Linda | California | 92354 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35202890 | Derived | Fleck BW, Reynolds JD, Zhu Q, Lepore D, Marlow N, Stahl A, Li J, Weisberger A, Fielder AR; RAINBOW Investigator Group. Time Course of Retinopathy of Prematurity Regression and Reactivation After Treatment with Ranibizumab or Laser in the RAINBOW Trial. Ophthalmol Retina. 2022 Jul;6(7):628-637. doi: 10.1016/j.oret.2022.02.006. Epub 2022 Feb 22. | |
| 31522845 |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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One patient was discontinued prior to receiving any study treatment and was later re-randomized; this patient is counted twice in the Randomized Set (FAS) (225). The number of unique participants randomized in the study is 224.
This study was conducted in 87 sites: Austria(2), Belgium(2), Croatia(2), Czech Republic(3), Denmark(1), Egypt(1), Estonia(1), France(2), Germany(2), Greece(3), Hungary(2), India(6), Italy(4), Japan(17), Lithuania(1), Malaysia(2), Mexico(1), Poland(2), Romania(3), Russia(5), Saudi Arabia(1), Slovakia(1), Taiwan(2), Turkey(6), UK(3) and USA(12).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab 0.2 mg | 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required |
| FG001 | Ranibizumab 0.1 mg | 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Treatment (Day 1 - Baseline) |
|
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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 | Feb 1, 2017 | Oct 15, 2018 |
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| Laser therapy | Procedure | Transpupillary diode or frequency-doubled yttrium aluminum garnet (YAG) laser ablative therapy, following anesthesia or sedation |
|
An event was defined as death, treatment switch, or the first occurrence of unfavorable structural outcomes in either eye. Only descriptive analysis done. |
| Day 1 (after initiation of study treatment) up to study exit (Day 169) |
| Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24 | Recurrence of ROP is defined as subjects receiving any post-baseline intervention in either eye at or before 24 weeks (ranibizumab re-treatment or switch to laser in the ranibizumab groups, switch to ranibizumab treatment in the laser group). Zone I consists of a circle, the radius of which extends from the center of the optic disc to twice the distance from the center of the optic disc to the center of the macula. Zone II extends centrifugally from the edge of zone I to the nasal ora serrata. Only descriptive analysis done. | Week 24 |
| Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 | Percent of Participants with Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done. | Week 24 |
| Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29 | Blood samples for the determination of ranibizumab concentrations were collected in the Ranibizumab treatment arms only at the following time points: within 24 hours after the first administration of ranibizumab, at Day 15 and at Day 29. Only descriptive analysis done. | Day 1 (Baseline), Day 15 and Day 29 |
| Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29 | Blood samples for the determination of systemic VEGF levels were collected at the following time points: before the first investigational treatment, at Day 15 and at Day 29. Only descriptive analysis done. | Day 1 (Baseline), Day 15 and Day 29 |
| Total Number of Ranibizumab Injections Received at Week 24 | Patients randomized to receive Ranibizumab 0.1 mg or 0.2 mg received a single dose of intravitreal Ranibizumab to each eye on Day 1 (Baseline). Only descriptive analysis done. | Week 24 |
| Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 | Percent of Participants with Non-Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done. | Week 24 |
| Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169 | Body Length, Head Circumference and Knee to Heel Length were assessed. Only descriptive analysis done. | Baseline, Day 85, Day 169 |
| Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169 | Body weight was measured. Only descriptive analysis done. | Baseline, Day 85, Day 169 |
| Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169 | Blood Pressure measurements were not required by the protocol. Instead, the most recent Systolic and Diastolic Blood Pressure expressed in millimeters of mercury (mmHg) measured as part of the routine clinical care were used. Only descriptive analysis done. | Baseline, Day 85, Day 169 |
| Sacramento |
| California |
| 95817 |
| United States |
| Novartis Investigative Site | Aurora | Colorado | 80045 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60612 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40208 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21201 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02111 | United States |
| Novartis Investigative Site | Ann Arbor | Michigan | 48105 | United States |
| Novartis Investigative Site | Rochester | New York | 14642 | United States |
| Novartis Investigative Site | Austin | Texas | 78705 | United States |
| Novartis Investigative Site | Salt Lake City | Utah | 84132 | United States |
| Novartis Investigative Site | Morgantown | West Virginia | 26506 | United States |
| Novartis Investigative Site | Graz | A-8036 | Austria |
| Novartis Investigative Site | Vienna | 1090 | Austria |
| Novartis Investigative Site | Bruges | 8000 | Belgium |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Osijek | 31000 | Croatia |
| Novartis Investigative Site | Zagreb | 10000 | Croatia |
| Novartis Investigative Site | Ostrava Poruba | Czech Republic | 708 52 | Czechia |
| Novartis Investigative Site | Praha 4 - Podoli | Czech Republic | 14700 | Czechia |
| Novartis Investigative Site | Prague | 12808 | Czechia |
| Novartis Investigative Site | Koebenhavn Ø | 2100 | Denmark |
| Novartis Investigative Site | Alexandria | 21131 | Egypt |
| Novartis Investigative Site | Tallinn | 13419 | Estonia |
| Novartis Investigative Site | Amiens | 80054 | France |
| Novartis Investigative Site | Marseille | 13915 | France |
| Novartis Investigative Site | Bonn | 53127 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Ampelokipoi | GR | 115 27 | Greece |
| Novartis Investigative Site | Thessaloniki | GR | 546 29 | Greece |
| Novartis Investigative Site | Goudi- Athens | 115 27 | Greece |
| Novartis Investigative Site | Budapest | 1125 | Hungary |
| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Ahmedabad | Gujarat | 380016 | India |
| Novartis Investigative Site | Mumbai | Maharashtra | 400 008 | India |
| Novartis Investigative Site | Coimbatore | Tamil Nadu | 641014 | India |
| Novartis Investigative Site | Madurai | Tamil Nadu | 625020 | India |
| Novartis Investigative Site | Vanchiyoor | Thiruvanantapuram | 695035 | India |
| Novartis Investigative Site | New Delhi | 110029 | India |
| Novartis Investigative Site | Florence | FI | 50139 | Italy |
| Novartis Investigative Site | Rome | Lazio | 00168 | Italy |
| Novartis Investigative Site | Perugia | PG | 06100 | Italy |
| Novartis Investigative Site | Fiumicino | RM | 00054 | Italy |
| Novartis Investigative Site | Nagoya | Aichi-ken | 453-8511 | Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 466 8560 | Japan |
| Novartis Investigative Site | Yachiyo | Chiba | 276-8524 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 812-8582 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 814-0180 | Japan |
| Novartis Investigative Site | Kurume | Fukuoka | 830-0011 | Japan |
| Novartis Investigative Site | Fukushima | Fukushima | 960-1295 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | Japan |
| Novartis Investigative Site | Zentsujichó | Kagawa-ken | 765-8507 | Japan |
| Novartis Investigative Site | Shimajiri-Gun | Okinawa | 901-1303 | Japan |
| Novartis Investigative Site | Izumi | Osaka | 594-1101 | Japan |
| Novartis Investigative Site | Ohtsu-city | Shiga | 520-2192 | Japan |
| Novartis Investigative Site | Fuchū | Tokyo | 183-8561 | Japan |
| Novartis Investigative Site | Ōta-ku | Tokyo | 143 8541 | Japan |
| Novartis Investigative Site | Setagaya-ku | Tokyo | 157-8535 | Japan |
| Novartis Investigative Site | Sumida-ku | Tokyo | 130-8575 | Japan |
| Novartis Investigative Site | Toshima-ku | Tokyo | 170-8476 | Japan |
| Novartis Investigative Site | Kaunas | LTU | LT-50161 | Lithuania |
| Novartis Investigative Site | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Novartis Investigative Site | Kota Kinabalu | Sabah | 88996 | Malaysia |
| Novartis Investigative Site | Querataro | 76090 | Mexico |
| Novartis Investigative Site | Bialystok | 15-274 | Poland |
| Novartis Investigative Site | Wroclaw | 51-124 | Poland |
| Novartis Investigative Site | Brasov | 500025 | Romania |
| Novartis Investigative Site | Bucharest | 020395 | Romania |
| Novartis Investigative Site | Timișoara | 300041 | Romania |
| Novartis Investigative Site | Cheboksary | 428028 | Russia |
| Novartis Investigative Site | Kazan' | 420012 | Russia |
| Novartis Investigative Site | Moscow | 127486 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194100 | Russia |
| Novartis Investigative Site | Riyadh | 11211 | Saudi Arabia |
| Novartis Investigative Site | Bratislava | 833 40 | Slovakia |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Taoyuan | 33305 | Taiwan |
| Novartis Investigative Site | Eskişehir | Meselik | 26480 | Turkey (Türkiye) |
| Novartis Investigative Site | Soguksu / Antalya | Turkey | 07100 | Turkey (Türkiye) |
| Novartis Investigative Site | Zuhuratbaba / Istanbul | Turkey | 34147 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06500 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34140 | Turkey (Türkiye) |
| Novartis Investigative Site | Manchester | M13 9WL | United Kingdom |
| Novartis Investigative Site | Oxford | OX3 9DU | United Kingdom |
| Novartis Investigative Site | Portsmouth | PO6 3LY | United Kingdom |
| Stahl A, Lepore D, Fielder A, Fleck B, Reynolds JD, Chiang MF, Li J, Liew M, Maier R, Zhu Q, Marlow N. Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): an open-label randomised controlled trial. Lancet. 2019 Oct 26;394(10208):1551-1559. doi: 10.1016/S0140-6736(19)31344-3. Epub 2019 Sep 12. |
| FG002 | Laser Therapy | Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed |
|
| Safety Set | At least 1 application of investigational treatment and a 1 post baseline safety assessment |
|
| VEGF Set | All patients who provided valid Vascular endothelial growth factor (VEGF) plasma samples |
|
| PK Set | All patients who provided Pharmacokinetics (PK) serum samples |
|
| COMPLETED | All patients who completed the treatment phase |
|
| NOT COMPLETED |
|
|
| Follow-Up Phase (up to Day 169) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab 0.2 mg | 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required |
| BG001 | Ranibizumab 0.1 mg | 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required |
| BG002 | Laser Therapy | Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed |
| BG003 | 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 (weeks) | Mean | Standard Deviation | Weeks |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 | To achieve this outcome, patients must fulfill all the following criteria, 1) survival, 2) no intervention with a second modality for ROP, 3) absence of active ROP and 4) absence of unfavorable structural outcome. Retinopathy of prematurity (ROP) is a pathologic process that occurs in the incompletely vascularized, developing retina of low birth-weight preterm neonates. | The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered. | Posted | Number | Percentage of Participants | Week 24 |
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| Secondary | Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24 | Intervention for ROP in either eye at or before the 24-week assessment visit with a treatment modality other than the modality of the first study treatment. Only descriptive analysis done. | The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit | An event was defined as death, treatment switch, or the first occurrence of unfavorable structural outcomes in either eye. Only descriptive analysis done. | The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered. | Posted | Number | Participants | Day 1 (after initiation of study treatment) up to study exit (Day 169) |
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| Secondary | Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24 | Recurrence of ROP is defined as subjects receiving any post-baseline intervention in either eye at or before 24 weeks (ranibizumab re-treatment or switch to laser in the ranibizumab groups, switch to ranibizumab treatment in the laser group). Zone I consists of a circle, the radius of which extends from the center of the optic disc to twice the distance from the center of the optic disc to the center of the macula. Zone II extends centrifugally from the edge of zone I to the nasal ora serrata. Only descriptive analysis done. | The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 | Percent of Participants with Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done. | The Safety Set was considered. | Posted | Number | Percent of participants | Week 24 |
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| Secondary | Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29 | Blood samples for the determination of ranibizumab concentrations were collected in the Ranibizumab treatment arms only at the following time points: within 24 hours after the first administration of ranibizumab, at Day 15 and at Day 29. Only descriptive analysis done. | The PK Set, which consisted of all participants with at least one valid PK concentration value, was considered. | Posted | Mean | Standard Deviation | picogram/milliliter (pg/mL) | Day 1 (Baseline), Day 15 and Day 29 |
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| Secondary | Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29 | Blood samples for the determination of systemic VEGF levels were collected at the following time points: before the first investigational treatment, at Day 15 and at Day 29. Only descriptive analysis done. | The VEGF Set, which consisted of all participants with at least one valid VEGF concentration value, was considered. | Posted | Mean | Standard Deviation | picogram/milliliter (pg/mL) | Day 1 (Baseline), Day 15 and Day 29 |
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| Secondary | Total Number of Ranibizumab Injections Received at Week 24 | Patients randomized to receive Ranibizumab 0.1 mg or 0.2 mg received a single dose of intravitreal Ranibizumab to each eye on Day 1 (Baseline). Only descriptive analysis done. | The Safety Set was considered. | Posted | Number | Injections | Week 24 |
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| Secondary | Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 | Percent of Participants with Non-Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done. | The Safety Set was considered. | Posted | Number | Percent of participants | Week 24 |
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| Secondary | Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169 | Body Length, Head Circumference and Knee to Heel Length were assessed. Only descriptive analysis done. | The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point. | Posted | Mean | Standard Deviation | centimeter (cm) | Baseline, Day 85, Day 169 |
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| Secondary | Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169 | Body weight was measured. Only descriptive analysis done. | The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point. | Posted | Mean | Standard Deviation | gram (g) | Baseline, Day 85, Day 169 |
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| Secondary | Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169 | Blood Pressure measurements were not required by the protocol. Instead, the most recent Systolic and Diastolic Blood Pressure expressed in millimeters of mercury (mmHg) measured as part of the routine clinical care were used. Only descriptive analysis done. | The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline, Day 85, Day 169 |
|
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit).
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
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 | Ranibizumab 0.2 mg | 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required | 4 | 73 | 26 | 73 | 43 | 73 |
| EG001 | Ranibizumab 0.1 mg | 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required | 4 | 76 | 24 | 76 | 47 | 76 |
| EG002 | Laser | Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed | 4 | 69 | 24 | 69 | 37 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ileal atresia | Congenital, familial and genetic disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Exophthalmos | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Retinopathy of prematurity | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Necrotising colitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| No adverse event | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Orbital infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Roseola | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Greenstick fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperphosphatasaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebral cyst | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Perinatal brain damage | Pregnancy, puerperium and perinatal conditions | MedDRA (20.1) | Systematic Assessment |
| |
| Breath holding | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Psychomotor retardation | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary vein stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tracheomalacia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dependence on oxygen therapy | Social circumstances | MedDRA (20.1) | Systematic Assessment |
| |
| Haemodynamic instability | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2018 | Oct 15, 2018 | SAP_003.pdf |
| 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 |
|---|---|
| D000069579 | Ranibizumab |
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Death |
|
| Withdrawal of Consent |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
|
|
| Participants |
|
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| Participants |
|
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