Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004048-36 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)
This was a multicenter, open-label extension study where the Visual Acuity (VA) assessment at the child's 5th birthday visit was performed. The study had 2 distinct periods (Epochs). Treatment with study ranibizumab (either as retreatment after ranibizumab had already been injected in the same eye or as switch ranibizumab treatment from study laser therapy administered in the core study) was permitted for eligible eyes with recurrence/worsening of ROP up to and including Week 40 from the baseline visit in the core study (Epoch 1). The remainder of the extension study up to the 5th birthday visit (Epoch 2) was observational, with no study treatment planned to be administered.
In the core study, patients were randomized to 1 of the 3 treatment arms (ranibizumab 0.2 mg, ranibizumab 0.1 mg, and laser). Treatment arm assignment and patient identifier in the extension study remained the same as in the core study.
Not provided
Not provided
Not provided
Not provided
| 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 | No Intervention | Laser therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms | The VA assessment at the child's 5th birthday visit was performed using Early Treatment Diabetic Retinopathy Study (ETDRS) methodology. VA measurements were taken in a sitting position at an initial test distance of 3 meters using Lea Symbols charts. Scores represented the number of optotypes (Lea symbols) the participant identified and ranged from 0 to 100, with higher scores indicating better visual acuity. VA was tested in each eye, using the child's current refractive index. The better-seeing eye was defined as the eye with the higher ETDRS score at the 5th birthday visit. If both eyes had the same ETDRS score, then the right eye was assigned as the better-seeing eye. | at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship by Preferred Term | Number of participants with ocular AEs starting during the core study and ongoing at extension baseline, or starting on/after extension baseline were reported. | throughout the study, approximately 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Sacramento | California | 95817 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38638400 | Derived | Marlow N, Reynolds JD, Lepore D, Fielder AR, Stahl A, Hao H, Weisberger A, Lodha A, Fleck BW. Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trial. EClinicalMedicine. 2024 Apr 11;71:102567. doi: 10.1016/j.eclinm.2024.102567. eCollection 2024 May. | |
| 34391532 |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
This study was not randomized. During Epoch 1 (starting at the baseline visit for the extension study up to 40 weeks from the baseline visit in the core study) participants continued to receive treatment as in the core study (NCT02375971). During Epoch 2 (starting at the end of Epoch 1 up to participant's 5th birthday) participants no longer received treatment (the study was observational)
Study was carried out in Austria (2), Belgium (2), Croatia (1), Czech Republic (3), Denmark (1), Egypt (1), Estonia (1), France (2), Germany (1), Greece (3), Hungary (2), India (6), Italy (4), Japan (16), Lithuania (1), Malaysia (2), Romania (3), Russian Federation (5), Saudi Arabia (1), Slovakia (1), Taiwan (2), Turkey (3), United Kingdom (2), United States of America (9)
Not provided
| 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 | |||||
|---|---|---|---|---|---|---|---|
| Epoch 1 |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2019 | Oct 20, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Number of Participants With Non-ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship (Greater Than or Equal to 3% in Any Arm) by Preferred Term |
Number of participants with non-ocular adverse events regardless of study treatment or procedure relationship (greater than or equal to 3% in any arm) by preferred term were reported. |
| throughout the study, approximately 5 years |
| Visual Acuity (VA) of the Worse-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms | The VA assessment at the child's 5th birthday visit was performed using Early Treatment Diabetic Retinopathy Study (ETDRS) methodology. VA measurements were taken in a sitting position at an initial test distance of 3 meters using Lea Symbols charts. Scores represented the number of optotypes (Lea symbols) the participant identified and ranged from 0 to 100, with higher scores indicating better visual acuity. VA was tested in each eye, using the child's current refractive index. The worse-seeing eye was the eye with a lower ETDRS score at the 5th birthday visit. If both eyes had the same ETDRS score, then the left eye was assigned as the worse-seeing eye. | at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
| Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 40 Weeks Post Core Baseline Visit | The absence of active ROP in both eyes is defined by the absence of all of the following features: (1) Vessel dilatation of plus disease in at least 2 quardrants (some persisting tortuosity is allowed), (2) Extra-retina vessels extending from the retina into the vitreous and judged to be a sign of active ROP disease. | at 40 weeks post core baseline visit |
| Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 52 Weeks Post Core Baseline Visit | The absence of active ROP in both eyes is defined by the absence of all of the following features: (1) Vessel dilatation of plus disease in at least 2 quardrants (some persisting tortuosity is allowed), (2) Extra-retina vessels extending from the retina into the vitreous and judged to be a sign of active ROP disease. | at 52 weeks post core baseline visit |
| Number of Participants With Absence of All Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit | The absence of all ocular structural abnormalities is defined by the absence of all of the following fundus features in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula | at or before 40 weeks post baseline visit |
| Number of Participants With Absence of All Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit | The absence of all ocular structural abnormalities is defined by the absence of all of the following fundus features in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula | at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit) |
| Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit | Number of participants with absence of each structural abnormality in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula, (5) Retinal detachment not involving the macula, (6) Pre-retinal fibrosis | at or before 40 weeks post baseline visit |
| Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit | Number of participants with absence of each structural abnormality in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula, (5) Retinal detachment not involving the macula, (6) Pre-retinal fibrosis, (7) Optic disc pallor, (8) Optic disc swelling, (9) Pigmentary disturbance in the macula, (10) Atrophic changes in the macula | at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit) |
| Number of Participants With Absence of All Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit | The absence of all ocular structural abnormalities is defined by the absence of all of the following fundus features in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula | at or before participant's 2 years corrected age visit (up to 2 years and 4 months post core baseline visit) |
| Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit | Number of participants with absence of each structural abnormality in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula, (5) Retinal detachment not involving the macula, (6) Pre-retinal fibrosis, (7) Optic disc pallor, (8) Optic disc swelling, (9) Pigmentary disturbance in the macula, (10) Atrophic changes in the macula | at or before participant's 2 years corrected age visit (up to 2 years and 4 months post core baseline visit) |
| Number of Participants With Recurrence of ROP up to 40 Weeks Post Baseline Visit in the Core Study | Recurrence of ROP was defined as ROP receiving any post-baseline intervention after the 1st study treatment in the core study. In the ranibizumab arms, post-baseline interventions were ranibizumab retreatment or switch to laser. In the laser arm, post-baseline interventions were supplementary laser treatments after 11 days post-baseline, or switch to ranibizumab; supplementary laser treatment within 11 days post-baseline was not counted as recurrence. | up to 40 weeks post baseline visit in the core study |
| Number of Participants With Recurrence of ROP up to 52 Weeks Post Baseline Visit in the Core Study | Recurrence of ROP was defined as ROP receiving any post-baseline intervention after the 1st study treatment in the core study. In the ranibizumab arms, post-baseline interventions were ranibizumab retreatment or switch to laser. In the laser arm, post-baseline interventions were supplementary laser treatments after 11 days post-baseline, or switch to ranibizumab; supplementary laser treatment within 11 days post-baseline was not counted as recurrence. Beyond Week 40, participants did not receive any study intervention and no new data was collected after 40 weeks post core baseline visit. | up to 52 weeks post baseline visit in the core study |
| Number of Ranibizumab Injections Received Per Participant Over the Whole Safety Observation Period | Number of ranibizumab injections received in the treatment of participants with ROP up to and including 40 weeks post baseline visit in the core study were reported. | up to and including 40 weeks post baseline visit in the core study |
| Refraction Status: Summary of Participants at Participant's 2 Years Corrected Age | Summary of participants was reported to evaluate the refraction in each eye at the participant's 2 years corrected age | at participant's 2 years corrected age (maximum 2 years and 4 months post core baseline visit) |
| Refraction Status: Summary of Participants at the Participant's Fifth Birthday Visit | Summary of participants was reported to evaluate the refraction in each eye at the participant's 2 years' corrected age | at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
| Change From Baseline in Weight | Subject´s weight was reported to evaluate the physical development. | Baseline of the core study, at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) and at the subjects' fifth birthday (maximum 5 years and 4 months post core baseline visit) |
| Change From Baseline in Head Circumference | Subject´s head circumference was reported to evaluate the physical development. | Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) |
| Change From Baseline in Sitting Diastolic Blood Pressure | Subject´s Sitting Diastolic Blood Pressure was reported to evaluate the physical development. | Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) |
| Change From Baseline in Sitting Systolic Blood Pressure | Subject´s Sitting Systolic Blood Pressure was reported to evaluate the physical development. | Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) |
| Number of Participants With the Summary of Respiratory Function Status | Number of participants with respiratory function status was reported | at the participants' fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
| Number of Participants With Hearing Impairment of Any Type | Number of participants with hearing function status was reported | at the participants' fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
| Duration of Hospitalization | Duration of hospitalization (from birth to first hospital discharge home) was reported to evaluate the health status of the subject | From baseline of the core study up to 5 years and 4 months post core baseline visit |
| Weight at the Time of First Hospital Discharge | Weight (gram) at the time of first hospital discharge was reported to evaluate the health status of the subject | From baseline of the core study up to 5 years and 4 months post core baseline visit |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Novartis Investigative Site | Chicago | Illinois | 60612 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40202 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21201 | 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 | 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 | Zagreb | 10000 | Croatia |
| Novartis Investigative Site | Praha 4 - Podoli | Czech Republic | 14700 | Czechia |
| Novartis Investigative Site | Ostrava | Poruba | 708 52 | Czechia |
| Novartis Investigative Site | Prague | 12808 | Czechia |
| Novartis Investigative Site | Koebenhavn Ø | 2100 | Denmark |
| Novartis Investigative Site | Alexandria | 21131 | Egypt |
| Novartis Investigative Site | Tallinn | 10138 | Estonia |
| Novartis Investigative Site | Amiens | 80054 | France |
| Novartis Investigative Site | Marseille | 13915 | France |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Ampelokipoi | GR | 115 27 | Greece |
| Novartis Investigative Site | Thessaloniki | GR | 564 03 | Greece |
| Novartis Investigative Site | 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 | Perugia | PG | 06100 | Italy |
| Novartis Investigative Site | Fiumicino | RM | 00054 | Italy |
| Novartis Investigative Site | Roma | RM | 00168 | 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 | 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 | 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 | Istanbul | Bakirkoy | 34140 | Turkey (Türkiye) |
| Novartis Investigative Site | Meselik | Eskişehir | 26480 | Turkey (Türkiye) |
| Novartis Investigative Site | Soguksu / Antalya | Turkey | 07100 | Turkey (Türkiye) |
| Novartis Investigative Site | Manchester | M13 9WL | United Kingdom |
| Novartis Investigative Site | Portsmouth | PO6 3LY | United Kingdom |
| Marlow N, Stahl A, Lepore D, Fielder A, Reynolds JD, Zhu Q, Weisberger A, Stiehl DP, Fleck B; RAINBOW investigators group. 2-year outcomes of ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW extension study): prospective follow-up of an open label, randomised controlled trial. Lancet Child Adolesc Health. 2021 Oct;5(10):698-707. doi: 10.1016/S2352-4642(21)00195-4. Epub 2021 Aug 13. |
| FG002 | Laser Therapy | Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed |
| COMPLETED | Number of subjects who completed post-treatment follow-up 1 (Epoch 1) |
|
| NOT COMPLETED |
|
|
| Epoch 2 |
|
|
Not provided
| 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 | Age at extension baseline visit | Mean | Standard Deviation | Weeks |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| 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 | Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms | The VA assessment at the child's 5th birthday visit was performed using Early Treatment Diabetic Retinopathy Study (ETDRS) methodology. VA measurements were taken in a sitting position at an initial test distance of 3 meters using Lea Symbols charts. Scores represented the number of optotypes (Lea symbols) the participant identified and ranged from 0 to 100, with higher scores indicating better visual acuity. VA was tested in each eye, using the child's current refractive index. The better-seeing eye was defined as the eye with the higher ETDRS score at the 5th birthday visit. If both eyes had the same ETDRS score, then the right eye was assigned as the better-seeing eye. | Extension Safety Set: defined as the subset of the participants from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Least Squares Mean | Standard Error | Score on a scale | at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship by Preferred Term | Number of participants with ocular AEs starting during the core study and ongoing at extension baseline, or starting on/after extension baseline were reported. | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Count of Participants | Participants | throughout the study, approximately 5 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Non-ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship (Greater Than or Equal to 3% in Any Arm) by Preferred Term | Number of participants with non-ocular adverse events regardless of study treatment or procedure relationship (greater than or equal to 3% in any arm) by preferred term were reported. | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Count of Participants | Participants | throughout the study, approximately 5 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Visual Acuity (VA) of the Worse-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms | The VA assessment at the child's 5th birthday visit was performed using Early Treatment Diabetic Retinopathy Study (ETDRS) methodology. VA measurements were taken in a sitting position at an initial test distance of 3 meters using Lea Symbols charts. Scores represented the number of optotypes (Lea symbols) the participant identified and ranged from 0 to 100, with higher scores indicating better visual acuity. VA was tested in each eye, using the child's current refractive index. The worse-seeing eye was the eye with a lower ETDRS score at the 5th birthday visit. If both eyes had the same ETDRS score, then the left eye was assigned as the worse-seeing eye. | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Least Squares Mean | Standard Error | Score on a scale | at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 40 Weeks Post Core Baseline Visit | The absence of active ROP in both eyes is defined by the absence of all of the following features: (1) Vessel dilatation of plus disease in at least 2 quardrants (some persisting tortuosity is allowed), (2) Extra-retina vessels extending from the retina into the vitreous and judged to be a sign of active ROP disease. | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. Number analyzed represents the number of participants with at least one non-missing value for the specific category and, therefore, it's not the same as the total number of participants analyzed. | Posted | Count of Participants | Participants | at 40 weeks post core baseline visit |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 52 Weeks Post Core Baseline Visit | The absence of active ROP in both eyes is defined by the absence of all of the following features: (1) Vessel dilatation of plus disease in at least 2 quardrants (some persisting tortuosity is allowed), (2) Extra-retina vessels extending from the retina into the vitreous and judged to be a sign of active ROP disease. | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Count of Participants | Participants | at 52 weeks post core baseline visit |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Absence of All Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit | The absence of all ocular structural abnormalities is defined by the absence of all of the following fundus features in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Count of Participants | Participants | at or before 40 weeks post baseline visit |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Absence of All Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit | The absence of all ocular structural abnormalities is defined by the absence of all of the following fundus features in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula | Extension Safety Set: defined as the subset of the participants from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Count of Participants | Participants | at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit | Number of participants with absence of each structural abnormality in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula, (5) Retinal detachment not involving the macula, (6) Pre-retinal fibrosis | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Count of Participants | Participants | at or before 40 weeks post baseline visit |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit | Number of participants with absence of each structural abnormality in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula, (5) Retinal detachment not involving the macula, (6) Pre-retinal fibrosis, (7) Optic disc pallor, (8) Optic disc swelling, (9) Pigmentary disturbance in the macula, (10) Atrophic changes in the macula | Extension Safety Set: defined as the subset of the participants from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Count of Participants | Participants | at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Absence of All Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit | The absence of all ocular structural abnormalities is defined by the absence of all of the following fundus features in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula | Extension Safety Set: defined as the subset of the participants from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Count of Participants | Participants | at or before participant's 2 years corrected age visit (up to 2 years and 4 months post core baseline visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit | Number of participants with absence of each structural abnormality in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula, (5) Retinal detachment not involving the macula, (6) Pre-retinal fibrosis, (7) Optic disc pallor, (8) Optic disc swelling, (9) Pigmentary disturbance in the macula, (10) Atrophic changes in the macula | Extension Safety Set: defined as the subset of the participants from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Count of Participants | Participants | at or before participant's 2 years corrected age visit (up to 2 years and 4 months post core baseline visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Recurrence of ROP up to 40 Weeks Post Baseline Visit in the Core Study | Recurrence of ROP was defined as ROP receiving any post-baseline intervention after the 1st study treatment in the core study. In the ranibizumab arms, post-baseline interventions were ranibizumab retreatment or switch to laser. In the laser arm, post-baseline interventions were supplementary laser treatments after 11 days post-baseline, or switch to ranibizumab; supplementary laser treatment within 11 days post-baseline was not counted as recurrence. | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Count of Participants | Participants | up to 40 weeks post baseline visit in the core study |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Recurrence of ROP up to 52 Weeks Post Baseline Visit in the Core Study | Recurrence of ROP was defined as ROP receiving any post-baseline intervention after the 1st study treatment in the core study. In the ranibizumab arms, post-baseline interventions were ranibizumab retreatment or switch to laser. In the laser arm, post-baseline interventions were supplementary laser treatments after 11 days post-baseline, or switch to ranibizumab; supplementary laser treatment within 11 days post-baseline was not counted as recurrence. Beyond Week 40, participants did not receive any study intervention and no new data was collected after 40 weeks post core baseline visit. | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Count of Participants | Participants | up to 52 weeks post baseline visit in the core study |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Ranibizumab Injections Received Per Participant Over the Whole Safety Observation Period | Number of ranibizumab injections received in the treatment of participants with ROP up to and including 40 weeks post baseline visit in the core study were reported. | Extension Safety Set: defined as the subset of the participants from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Mean | Standard Deviation | Number of injections | up to and including 40 weeks post baseline visit in the core study |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Refraction Status: Summary of Participants at Participant's 2 Years Corrected Age | Summary of participants was reported to evaluate the refraction in each eye at the participant's 2 years corrected age | Extension Safety Set: defined as the subset of the participants from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Mean | Standard Deviation | diopters | at participant's 2 years corrected age (maximum 2 years and 4 months post core baseline visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Refraction Status: Summary of Participants at the Participant's Fifth Birthday Visit | Summary of participants was reported to evaluate the refraction in each eye at the participant's 2 years' corrected age | Extension Safety Set: defined as the subset of the participants from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Mean | Standard Deviation | diopters | at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Weight | Subject´s weight was reported to evaluate the physical development. | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. Number analyzed represents the number of participants with at least one non-missing value for the specific category and, therefore, it's not the same as the total number of participants analyzed. | Posted | Mean | Standard Deviation | grams | Baseline of the core study, at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) and at the subjects' fifth birthday (maximum 5 years and 4 months post core baseline visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Head Circumference | Subject´s head circumference was reported to evaluate the physical development. | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Mean | Standard Deviation | cm | Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sitting Diastolic Blood Pressure | Subject´s Sitting Diastolic Blood Pressure was reported to evaluate the physical development. | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sitting Systolic Blood Pressure | Subject´s Sitting Systolic Blood Pressure was reported to evaluate the physical development. | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Summary of Respiratory Function Status | Number of participants with respiratory function status was reported | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. Number analyzed represents the number of participants with at least one non-missing value for the specific category and, therefore, it's not the same as the total number of participants analyzed. | Posted | Count of Participants | Participants | at the participants' fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hearing Impairment of Any Type | Number of participants with hearing function status was reported | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Count of Participants | Participants | at the participants' fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Hospitalization | Duration of hospitalization (from birth to first hospital discharge home) was reported to evaluate the health status of the subject | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Mean | Standard Deviation | days | From baseline of the core study up to 5 years and 4 months post core baseline visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Weight at the Time of First Hospital Discharge | Weight (gram) at the time of first hospital discharge was reported to evaluate the health status of the subject | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Posted | Mean | Standard Deviation | gram | From baseline of the core study up to 5 years and 4 months post core baseline visit |
|
throughout the study, up to approximately 5 years
Deaths happened after extension baseline are counted. Serious Adverse Events (SAEs) and Non-SAEs that started during core study and were ongoing at extension baseline or started on/after extension baseline are counted.
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 | 0 | 61 | 21 | 61 | 41 | 61 |
| 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 | 0 | 65 | 27 | 65 | 46 | 65 |
| EG002 | Laser Therapy | Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed | 2 | 54 | 26 | 54 | 40 | 54 |
| EG003 | Total | Total of all the participants | 2 | 180 | 74 | 180 | 127 | 180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebral palsy | Congenital, familial and genetic disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Coarctation of the aorta | Congenital, familial and genetic disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinopathy of prematurity | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acetonaemic vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Necrotising colitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Developmental delay | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Bacterial food poisoning | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Gastroenteritis adenovirus | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Leptospirosis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Parainfluenzae viral bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Viral tonsillitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Foreign body in respiratory tract | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperphosphatasaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Motor dysfunction | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Periventricular leukomalacia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Quadriparesis | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Perinatal brain damage | Pregnancy, puerperium and perinatal conditions | MedDRA (25.0) | Systematic Assessment |
| |
| Psychomotor retardation | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nasal discharge discolouration | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pulmonary vein stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Urticarial vasculitis | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Astigmatism | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Strabismus | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Developmental delay | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rickets | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Autism spectrum disorder | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | 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_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2022 | Oct 20, 2022 | SAP_001.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 |
| 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 |
Not provided
Not provided
| Lost to Follow-up |
|
| Death |
|
| Male |
|
| Black |
|
| Asian |
|
| Native American |
|
| Pacific Islander |
|
| Unknown |
|
| Other |
|
primary endpoint in the extension study does not have p-values. It's a descriptive analysis. |
| Mean Difference (Net) |
| 2.5 |
| Standard Error of the Mean |
| 2.96 |
| 2-Sided |
| 95 |
| -3.4 |
| 8.3 |
| Superiority |
| ANOVA | primary endpoint in the extension study does not have p-values. It's a descriptive analysis. | Mean Difference (Net) | 2.2 | Standard Error of the Mean | 2.79 | 2-Sided | 95 | -3.3 | 7.8 | Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| OG002 | Laser Therapy | Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed |
|
|
|
Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
|
|
|
|
Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
|
|
| Laser Therapy |
Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed |
|
|
Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed |
|
|
| OG002 | Laser Therapy | Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed |
|
|
| Laser Therapy |
Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed |
|
|
| OG002 | Laser Therapy | Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed |
|
|
Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed |
|
|
| OG002 |
| Laser Therapy |
Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|