Trial Outcomes & Findings for RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity (NCT NCT02375971)

Last Updated: 2018-11-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

224 participants

Primary outcome timeframe

Week 24

Results posted on

2018-11-14

Participant Flow

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).

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.

Participant milestones

Participant milestones
Measure	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	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	Laser Therapy Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Treatment (Day 1 - Baseline) STARTED	74	77	74
Treatment (Day 1 - Baseline) Safety Set	73	76	69
Treatment (Day 1 - Baseline) VEGF Set	19	26	51
Treatment (Day 1 - Baseline) PK Set	49	46	0
Treatment (Day 1 - Baseline) COMPLETED	73	76	69
Treatment (Day 1 - Baseline) NOT COMPLETED	1	1	5
Follow-Up Phase (up to Day 169) STARTED	73	76	69
Follow-Up Phase (up to Day 169) COMPLETED	66	71	64
Follow-Up Phase (up to Day 169) NOT COMPLETED	7	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	Laser Therapy Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Treatment (Day 1 - Baseline) Subj/Guardian Decision	0	0	2
Treatment (Day 1 - Baseline) Physician Decision	1	1	1
Treatment (Day 1 - Baseline) Lost to Follow-up	0	0	1
Treatment (Day 1 - Baseline) Adverse Event	0	0	1
Follow-Up Phase (up to Day 169) Adverse Event	1	0	0
Follow-Up Phase (up to Day 169) Subject/Guardian Decision	1	0	1
Follow-Up Phase (up to Day 169) Death	4	4	4
Follow-Up Phase (up to Day 169) Withdrawal of Consent	1	1	0

Baseline Characteristics

RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranibizumab 0.2 mg n=74 Participants 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 n=77 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy n=74 Participants Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed	Total n=225 Participants Total of all reporting groups
Age, Continuous	25.8 Weeks STANDARD_DEVIATION 2.25 • n=5 Participants	26.5 Weeks STANDARD_DEVIATION 2.57 • n=7 Participants	26.2 Weeks STANDARD_DEVIATION 2.59 • n=5 Participants	26.1 Weeks STANDARD_DEVIATION 2.48 • n=4 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	40 Participants n=7 Participants	37 Participants n=5 Participants	118 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	37 Participants n=7 Participants	37 Participants n=5 Participants	107 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	27 Participants n=5 Participants	22 Participants n=7 Participants	23 Participants n=5 Participants	72 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	45 Participants n=7 Participants	45 Participants n=5 Participants	133 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.2 mg n=74 Participants 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 n=77 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy n=74 Participants Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24	80.0 Percentage of Participants	75.0 Percentage of Participants	66.2 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24

Population: The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.

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.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.2 mg n=74 Participants 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 n=77 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy n=74 Participants Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24	14.9 Percentage of participants	16.9 Percentage of participants	24.3 Percentage of participants

SECONDARY outcome

Timeframe: Day 1 (after initiation of study treatment) up to study exit (Day 169)

Population: The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.

An event was defined as death, treatment switch, or the first occurrence of unfavorable structural outcomes in either eye. Only descriptive analysis done.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.2 mg n=74 Participants 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 n=77 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy n=74 Participants Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit	14 Participants	18 Participants	23 Participants

SECONDARY outcome

Timeframe: Week 24

Population: The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.

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.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.2 mg n=74 Participants 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 n=77 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy n=74 Participants Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24 All participants	31.1 Percentage of participants	31.2 Percentage of participants	18.9 Percentage of participants
Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24 ZONE I	35.7 Percentage of participants	53.3 Percentage of participants	28.6 Percentage of participants
Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24 ZONE II	28.3 Percentage of participants	17.4 Percentage of participants	13.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: The Safety Set was considered.

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.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.2 mg n=73 Participants 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 n=76 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy n=69 Participants Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 Mild	23.3 Percent of participants	32.9 Percent of participants	17.4 Percent of participants
Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 Moderate	4.1 Percent of participants	6.6 Percent of participants	13.0 Percent of participants
Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 Severe	2.7 Percent of participants	1.3 Percent of participants	2.9 Percent of participants

SECONDARY outcome

Timeframe: Day 1 (Baseline), Day 15 and Day 29

Population: The PK Set, which consisted of all participants with at least one valid PK concentration value, was considered.

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.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.2 mg n=49 Participants 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 n=46 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29 Day 1 (Baseline)	24700.0 picogram/milliliter (pg/mL) Standard Deviation 52400.00	12100.0 picogram/milliliter (pg/mL) Standard Deviation 25500.0	—
Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29 Day 15	5830.0 picogram/milliliter (pg/mL) Standard Deviation 4750.0	27700.0 picogram/milliliter (pg/mL) Standard Deviation 144000	—
Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29 Day 29	1810.0 picogram/milliliter (pg/mL) Standard Deviation 2990.0	732.0 picogram/milliliter (pg/mL) Standard Deviation 535.0	—

SECONDARY outcome

Timeframe: Day 1 (Baseline), Day 15 and Day 29

Population: The VEGF Set, which consisted of all participants with at least one valid VEGF concentration value, was considered.

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.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.2 mg n=19 Participants 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 n=26 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy n=51 Participants Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29 Day 1	239.0 picogram/milliliter (pg/mL) Standard Deviation 226.0	230.0 picogram/milliliter (pg/mL) Standard Deviation 224.0	232.0 picogram/milliliter (pg/mL) Standard Deviation 240.0
Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29 Day 1 / no treatment modality switch	239.0 picogram/milliliter (pg/mL) Standard Deviation 226.0	239.0 picogram/milliliter (pg/mL) Standard Deviation 233.0	233.0 picogram/milliliter (pg/mL) Standard Deviation 245.0
Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29 Day 15	466.0 picogram/milliliter (pg/mL) Standard Deviation 1500.0	118.0 picogram/milliliter (pg/mL) Standard Deviation 129.0	180.0 picogram/milliliter (pg/mL) Standard Deviation 214.0
Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29 Day 15 / no treatment modality switch	498.0 picogram/milliliter (pg/mL) Standard Deviation 1560.0	124.0 picogram/milliliter (pg/mL) Standard Deviation 134.0	177.0 picogram/milliliter (pg/mL) Standard Deviation 224.0
Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29 Day 29	117.0 picogram/milliliter (pg/mL) Standard Deviation 84.0	176.0 picogram/milliliter (pg/mL) Standard Deviation 142.0	161.0 picogram/milliliter (pg/mL) Standard Deviation 132.0
Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29 Day 29 / no treatment modality switch	117.0 picogram/milliliter (pg/mL) Standard Deviation 84.0	139.0 picogram/milliliter (pg/mL) Standard Deviation 75.3	163.0 picogram/milliliter (pg/mL) Standard Deviation 138.0

SECONDARY outcome

Timeframe: Week 24

Population: The Safety Set was considered.

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.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.2 mg n=73 Participants 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 n=76 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy n=69 Participants Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Total Number of Ranibizumab Injections Received at Week 24	73 Injections	76 Injections	13 Injections

SECONDARY outcome

Timeframe: Week 24

Population: The Safety Set was considered.

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.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.2 mg n=73 Participants 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 n=76 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy n=69 Participants Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 Mild	37.0 Percent of participants	27.6 Percent of participants	31.9 Percent of participants
Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 Moderate	24.7 Percent of participants	34.2 Percent of participants	27.5 Percent of participants
Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 Severe	23.3 Percent of participants	19.7 Percent of participants	17.4 Percent of participants

SECONDARY outcome

Timeframe: Baseline, Day 85, Day 169

Population: The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point.

Body Length, Head Circumference and Knee to Heel Length were assessed. Only descriptive analysis done.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.2 mg n=73 Participants 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 n=76 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy n=69 Participants Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169 Day 85 / Body Length	10.1 centimeter (cm) Standard Deviation 2.59	11.0 centimeter (cm) Standard Deviation 3.33	11.1 centimeter (cm) Standard Deviation 3.65
Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169 Day 169 / Body Length	18.7 centimeter (cm) Standard Deviation 3.28	18.6 centimeter (cm) Standard Deviation 3.66	19.0 centimeter (cm) Standard Deviation 4.50
Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169 Day 85 / Head Circumference	6.9 centimeter (cm) Standard Deviation 1.96	6.5 centimeter (cm) Standard Deviation 2.31	7.2 centimeter (cm) Standard Deviation 2.13
Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169 Day 169 / Head Circumference	10.4 centimeter (cm) Standard Deviation 2.12	10.3 centimeter (cm) Standard Deviation 2.56	10.6 centimeter (cm) Standard Deviation 2.61
Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169 Day 85 / Knee to Heel Length	2.9 centimeter (cm) Standard Deviation 1.90	3.1 centimeter (cm) Standard Deviation 1.65	3.1 centimeter (cm) Standard Deviation 2.02
Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169 Day 169 / Knee to Heel Length	5.4 centimeter (cm) Standard Deviation 2.86	5.1 centimeter (cm) Standard Deviation 2.19	5.3 centimeter (cm) Standard Deviation 2.15

SECONDARY outcome

Timeframe: Baseline, Day 85, Day 169

Population: The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point.

Body weight was measured. Only descriptive analysis done.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.2 mg n=73 Participants 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 n=76 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy n=69 Participants Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169 Day 169 / Weight	3794.3 gram (g) Standard Deviation 782.48	3716.7 gram (g) Standard Deviation 897.15	3826.0 gram (g) Standard Deviation 882.17
Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169 Day 85 / Weight	2198.9 gram (g) Standard Deviation 615.68	2149.9 gram (g) Standard Deviation 754.27	2182.7 gram (g) Standard Deviation 612.70

SECONDARY outcome

Timeframe: Baseline, Day 85, Day 169

Population: The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point.

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.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.2 mg n=73 Participants 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 n=76 Participants 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required	Laser Therapy n=69 Participants Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169 Day 85 / Sitting Diastolic Blood Pressure	8.1 millimeters of mercury (mmHg) Standard Deviation 14.66	7.0 millimeters of mercury (mmHg) Standard Deviation 14.25	9.8 millimeters of mercury (mmHg) Standard Deviation 16.95
Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169 Day 85 / Sitting Systolic Blood Pressure	6.3 millimeters of mercury (mmHg) Standard Deviation 15.85	9.4 millimeters of mercury (mmHg) Standard Deviation 15.73	15.5 millimeters of mercury (mmHg) Standard Deviation 16.85
Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169 Day 169 / Sitting Diastolic Blood Pressure	11.5 millimeters of mercury (mmHg) Standard Deviation 15.60	11.8 millimeters of mercury (mmHg) Standard Deviation 14.42	14.7 millimeters of mercury (mmHg) Standard Deviation 17.05
Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169 Day 169 / Sitting Systolic Blood Pressure	10.2 millimeters of mercury (mmHg) Standard Deviation 16.15	11.2 millimeters of mercury (mmHg) Standard Deviation 13.45	17.7 millimeters of mercury (mmHg) Standard Deviation 19.35

Adverse Events

Ranibizumab 0.2 mg

Serious events: 26 serious events

Other events: 43 other events

Deaths: 4 deaths

Ranibizumab 0.1 mg

Serious events: 24 serious events

Other events: 47 other events

Deaths: 4 deaths

Laser

Serious events: 24 serious events

Other events: 37 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER