Eligibility, any sex, with Retinopathy of Prematurity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24Primary· 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.
Group
Value
95% CI
Ranibizumab 0.2 mg
80.0
Ranibizumab 0.1 mg
75.0
Laser Therapy
66.2
Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24Secondary· 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.
Group
Value
95% CI
Ranibizumab 0.2 mg
14.9
Ranibizumab 0.1 mg
16.9
Laser Therapy
24.3
Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study VisitSecondary· Day 1 (after initiation of study treatment) up to study exit (Day 169)
An event was defined as death, treatment switch, or the first occurrence of unfavorable structural outcomes in either eye. Only descriptive analysis done.
Group
Value
95% CI
Ranibizumab 0.2 mg
14
Ranibizumab 0.1 mg
18
Laser Therapy
23
Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24Secondary· 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.
All participants
Group
Value
95% CI
Ranibizumab 0.2 mg
31.1
Ranibizumab 0.1 mg
31.2
Laser Therapy
18.9
ZONE I
Group
Value
95% CI
Ranibizumab 0.2 mg
35.7
Ranibizumab 0.1 mg
53.3
Laser Therapy
28.6
ZONE II
Group
Value
95% CI
Ranibizumab 0.2 mg
28.3
Ranibizumab 0.1 mg
17.4
Laser Therapy
13.0
Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24Secondary· 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.
Mild
Group
Value
95% CI
Ranibizumab 0.2 mg
23.3
Ranibizumab 0.1 mg
32.9
Laser Therapy
17.4
Moderate
Group
Value
95% CI
Ranibizumab 0.2 mg
4.1
Ranibizumab 0.1 mg
6.6
Laser Therapy
13.0
Severe
Group
Value
95% CI
Ranibizumab 0.2 mg
2.7
Ranibizumab 0.1 mg
1.3
Laser Therapy
2.9
Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29Secondary· Day 1 (Baseline), 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)
Group
Value
95% CI
Ranibizumab 0.2 mg
24700.0
± 52400.00
Ranibizumab 0.1 mg
12100.0
± 25500.0
Day 15
Group
Value
95% CI
Ranibizumab 0.2 mg
5830.0
± 4750.0
Ranibizumab 0.1 mg
27700.0
± 144000
Day 29
Group
Value
95% CI
Ranibizumab 0.2 mg
1810.0
± 2990.0
Ranibizumab 0.1 mg
732.0
± 535.0
Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29Secondary· Day 1 (Baseline), 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
Group
Value
95% CI
Ranibizumab 0.2 mg
239.0
± 226.0
Ranibizumab 0.1 mg
230.0
± 224.0
Laser Therapy
232.0
± 240.0
Day 1 / no treatment modality switch
Group
Value
95% CI
Ranibizumab 0.2 mg
239.0
± 226.0
Ranibizumab 0.1 mg
239.0
± 233.0
Laser Therapy
233.0
± 245.0
Day 15
Group
Value
95% CI
Ranibizumab 0.2 mg
466.0
± 1500.0
Ranibizumab 0.1 mg
118.0
± 129.0
Laser Therapy
180.0
± 214.0
Day 15 / no treatment modality switch
Group
Value
95% CI
Ranibizumab 0.2 mg
498.0
± 1560.0
Ranibizumab 0.1 mg
124.0
± 134.0
Laser Therapy
177.0
± 224.0
Day 29
Group
Value
95% CI
Ranibizumab 0.2 mg
117.0
± 84.0
Ranibizumab 0.1 mg
176.0
± 142.0
Laser Therapy
161.0
± 132.0
Day 29 / no treatment modality switch
Group
Value
95% CI
Ranibizumab 0.2 mg
117.0
± 84.0
Ranibizumab 0.1 mg
139.0
± 75.3
Laser Therapy
163.0
± 138.0
Total Number of Ranibizumab Injections Received at Week 24Secondary· 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.
Group
Value
95% CI
Ranibizumab 0.2 mg
73
Ranibizumab 0.1 mg
76
Laser Therapy
13
Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24Secondary· 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.
Mild
Group
Value
95% CI
Ranibizumab 0.2 mg
37.0
Ranibizumab 0.1 mg
27.6
Laser Therapy
31.9
Moderate
Group
Value
95% CI
Ranibizumab 0.2 mg
24.7
Ranibizumab 0.1 mg
34.2
Laser Therapy
27.5
Severe
Group
Value
95% CI
Ranibizumab 0.2 mg
23.3
Ranibizumab 0.1 mg
19.7
Laser Therapy
17.4
Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169Secondary· Baseline, Day 85, Day 169
Body Length, Head Circumference and Knee to Heel Length were assessed. Only descriptive analysis done.
Day 85 / Body Length
Group
Value
95% CI
Ranibizumab 0.2 mg
10.1
± 2.59
Ranibizumab 0.1 mg
11.0
± 3.33
Laser Therapy
11.1
± 3.65
Day 169 / Body Length
Group
Value
95% CI
Ranibizumab 0.2 mg
18.7
± 3.28
Ranibizumab 0.1 mg
18.6
± 3.66
Laser Therapy
19.0
± 4.50
Day 85 / Head Circumference
Group
Value
95% CI
Ranibizumab 0.2 mg
6.9
± 1.96
Ranibizumab 0.1 mg
6.5
± 2.31
Laser Therapy
7.2
± 2.13
Day 169 / Head Circumference
Group
Value
95% CI
Ranibizumab 0.2 mg
10.4
± 2.12
Ranibizumab 0.1 mg
10.3
± 2.56
Laser Therapy
10.6
± 2.61
Day 85 / Knee to Heel Length
Group
Value
95% CI
Ranibizumab 0.2 mg
2.9
± 1.90
Ranibizumab 0.1 mg
3.1
± 1.65
Laser Therapy
3.1
± 2.02
Day 169 / Knee to Heel Length
Group
Value
95% CI
Ranibizumab 0.2 mg
5.4
± 2.86
Ranibizumab 0.1 mg
5.1
± 2.19
Laser Therapy
5.3
± 2.15
Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169Secondary· Baseline, Day 85, Day 169
Body weight was measured. Only descriptive analysis done.
Day 85 / Weight
Group
Value
95% CI
Ranibizumab 0.2 mg
2198.9
± 615.68
Ranibizumab 0.1 mg
2149.9
± 754.27
Laser Therapy
2182.7
± 612.70
Day 169 / Weight
Group
Value
95% CI
Ranibizumab 0.2 mg
3794.3
± 782.48
Ranibizumab 0.1 mg
3716.7
± 897.15
Laser Therapy
3826.0
± 882.17
Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169Secondary· Baseline, Day 85, 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.
Day 85 / Sitting Diastolic Blood Pressure
Group
Value
95% CI
Ranibizumab 0.2 mg
8.1
± 14.66
Ranibizumab 0.1 mg
7.0
± 14.25
Laser Therapy
9.8
± 16.95
Day 85 / Sitting Systolic Blood Pressure
Group
Value
95% CI
Ranibizumab 0.2 mg
6.3
± 15.85
Ranibizumab 0.1 mg
9.4
± 15.73
Laser Therapy
15.5
± 16.85
Day 169 / Sitting Diastolic Blood Pressure
Group
Value
95% CI
Ranibizumab 0.2 mg
11.5
± 15.60
Ranibizumab 0.1 mg
11.8
± 14.42
Laser Therapy
14.7
± 17.05
Day 169 / Sitting Systolic Blood Pressure
Group
Value
95% CI
Ranibizumab 0.2 mg
10.2
± 16.15
Ranibizumab 0.1 mg
11.2
± 13.45
Laser Therapy
17.7
± 19.35
Adverse events — posted to ClinicalTrials.gov
Time frame: 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)..
Reporting threshold: 4%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06847542 — A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
· Phase 3
· recruiting
NCT06957080 — A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
· Phase 2, PHASE3
· active not recruiting
NCT06176352 — A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Path
· Phase 3
· active not recruiting
NCT05126966 — A Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Afl
· Phase 3
· withdrawn
NCT05480293 — This Study Will Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection (IVT) With Ranibizumab
· Phase 3
· unknown
Other recruiting trials for Retinopathy of Prematurity
Currently open trials in the same condition.
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· recruiting
NCT06109285 — Validation of i-ROP DL to Detect More Than Mild ROP
· NA
· active not recruiting
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NCT06265363 — Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey.
· recruiting
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 14 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02375971.