Trial Outcomes & Findings for Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy (NCT NCT04278417)

NCT ID: NCT04278417

Last Updated: 2025-10-16

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

689 participants

Primary outcome timeframe

Baseline, Week 54

Results posted on

2025-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Brolucizumab 6 mg Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Overall Study STARTED	347	342
Overall Study COMPLETED	301	287
Overall Study NOT COMPLETED	46	55

Reasons for withdrawal

Reasons for withdrawal
Measure	Brolucizumab 6 mg Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Overall Study Progressive disease	0	2
Overall Study Physician Decision	4	6
Overall Study Lost to Follow-up	11	13
Overall Study Death	8	9
Overall Study Adverse Event	3	5
Overall Study Withdrawal by Subject	20	20

Baseline Characteristics

Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brolucizumab 6 mg n=347 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=342 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.	Total n=689 Participants Total of all reporting groups
Age, Continuous	53.2 Years STANDARD_DEVIATION 11.88 • n=5 Participants	54.7 Years STANDARD_DEVIATION 10.83 • n=7 Participants	53.9 Years STANDARD_DEVIATION 11.39 • n=5 Participants
Sex: Female, Male Female	144 Participants n=5 Participants	132 Participants n=7 Participants	276 Participants n=5 Participants
Sex: Female, Male Male	203 Participants n=5 Participants	210 Participants n=7 Participants	413 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	157 Participants n=5 Participants	148 Participants n=7 Participants	305 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	16 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) White	166 Participants n=5 Participants	169 Participants n=7 Participants	335 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 54

Population: Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=342 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=337 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye	0.2 Letters Read Standard Error 0.72	-4.2 Letters Read Standard Error 0.73

SECONDARY outcome

Timeframe: Week 54

Population: Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.

Proliferative diabetic retinopathy (PDR) is derived from the diabetic retinopathy severity scale (DRSS) as assessed by the central reading center (CRC) using 7-field color fundus photography image. The DRSS on the original score with scores varying from 10 (DR absent) to 85 (very advanced PDR) were then converted into a 12-level scale (Range is from 1 - diabetic retinopathy (DR) absent, to 12- very advanced PDR). (A lower score represents a better outcome.) The event of "No PDR" is then defined as DRSS (12-level scale) \< 7.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=294 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=290 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54 for the Study Eye	187 Participants	65 Participants

SECONDARY outcome

Timeframe: Week 96

Population: Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=310 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=303 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye	188 Participants	86 Participants

SECONDARY outcome

Timeframe: Up to Week 54

Population: Full Analysis Set (FAS), for patients with a valid measurement with no protocol deviations with impact.

Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. PRP = Panretinal photocoagulation laser

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=347 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=341 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54 for the Study Eye	108 Participants	248 Participants

SECONDARY outcome

Timeframe: Up to Week 96

Population: Full Analysis Set (FAS), for patients with a valid measurement with no protocol deviations with impact.

Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. PRP = Panretinal photocoagulation laser

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=347 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=341 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 96 for the Study Eye	126 Participants	262 Participants

SECONDARY outcome

Timeframe: Baseline, up to Week 54 and up to Week 96

Population: Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of \>= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. The AUC in change from Baseline in BCVA up to Week 54 (or Week 96) is referred to as the averaged change from Baseline in BCVA at each visit up to 54 (or Week 96), which was calculated as (BCVA at Week 6 + BCVA at Week 12 + ... + BCVA at Week 54 (or Week 96)) / number of visits with valid BCVA data from Week 6 to Week 54 (or Week 96) - BCVA at Baseline.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=342 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=337 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Area Under the Curve in Change From Baseline in BCVA up to Week 54 and up to Week 96 - for the Study Eye up to Week 54	0.5 Letters read Interval -0.4 to 1.4	-3.2 Letters read Interval -4.2 to -2.3
Area Under the Curve in Change From Baseline in BCVA up to Week 54 and up to Week 96 - for the Study Eye up to Week 96	-0.1 Letters read Interval -1.2 to 1.1	-4.3 Letters read Interval -5.4 to -3.1

SECONDARY outcome

Timeframe: Baseline, Week 54 and Week 96

Population: Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.

Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=295 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=289 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 Week 54 (n=282, 279)	128 Participants	57 Participants
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 Week 96 (n=295, 289)	123 Participants	65 Participants

SECONDARY outcome

Timeframe: Baseline, Week 54 and Week 96

Population: Full Analysis Set- Observed, for patients with a valid measurement with no protocol deviations with impact.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=236 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=220 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 Week 54 (n=225,220)	6 Participants	31 Participants
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 Week 96 (n=236, 201)	18 Participants	27 Participants

SECONDARY outcome

Timeframe: Baseline, Week 54 and Week 96

Population: Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=295 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=289 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 Week 54 (n=282, 279)	58 Participants	30 Participants
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 Week 96 (n=295, 289)	49 Participants	33 Participants

SECONDARY outcome

Timeframe: Baseline, Week 54 and Week 96

Population: Full Analysis Set-Observed, for patients with a valid measurement with no protocol deviations with impact.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=236 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=220 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 Week 54 (n=225, 220)	4 Participants	16 Participants
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 Week 96 (n=236, 201)	11 Participants	16 Participants

SECONDARY outcome

Timeframe: up to Week 54 and up to Week 96

Population: Full Analysis Set - Observed, for patients with a valid measurement with no protocol deviations with impact.

The vision-threatening complications associated with Diabetic retinopathy (DR) are defined as any event of the following list occurring in the study eye at any time point after Baseline: * Center-involved Diabetic macular edema (CI-DME) as defined as Central sub-field thickness (CSFT) ≥280 µm according to Central reading center (CRC) evaluation of Optical coherent tomography (OCT) image * Retinal detachment * Vitreous hemorrhage * Neovascular glaucoma, iris/ anterior chamber angle neovascularization * Vitrectomy for DR complications

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=347 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=342 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Number and Percentage of Subjects Developing Vision-threatening Complications Associated With Diabetic Retinopathy up to Week 54 and up to Week 96 up to Week 54	117 Participants	258 Participants
Number and Percentage of Subjects Developing Vision-threatening Complications Associated With Diabetic Retinopathy up to Week 54 and up to Week 96 up to Week 96	144 Participants	270 Participants

SECONDARY outcome

Timeframe: Adverse events are reported from first dose of study treatment up to Week 90, plus approximately 6 weeks post-treatment, up to a maximum timeframe of approximately 96 weeks.

Population: Safety Set

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. AEs that started after alternative diabetic retinopathy treatment/relevant diabetic macular edema treatment in the study eye are censored.

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=347 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=342 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye Number of subjects with at least one AE	152 Participants	199 Participants
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye -Vitreous hemorrhage	38 Participants	83 Participants
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye -Cataract	26 Participants	27 Participants
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye -Dry eye	15 Participants	8 Participants
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye -Intraocular pressure increased	12 Participants	3 Participants
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye -Conjunctival hemorrhage	10 Participants	5 Participants
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye -Macular oedema	9 Participants	34 Participants
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye -Vitreous floaters	9 Participants	9 Participants
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye -Conjunctivitis	7 Participants	4 Participants
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye -Diabetic retinal oedema	7 Participants	36 Participants
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye -Retinal hemorrhage	5 Participants	12 Participants
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye -Diabetic retinopathy	4 Participants	13 Participants
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye -Eye pain	3 Participants	7 Participants

SECONDARY outcome

Timeframe: Adverse events are reported from first dose of study treatment up to Week 90, plus approximately 6 weeks post-treatment, up to a maximum timeframe of approximately 96 weeks.

Population: Safety Set

Outcome measures

Outcome measures
Measure	Brolucizumab 6 mg n=347 Participants Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.	Panretinal Photocoagulation Laser Arm n=342 Participants Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed.
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Number of subjects with at least one AE	226 Participants	217 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term COVID-19	44 Participants	47 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Hypertension	35 Participants	24 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Upper respiratory tract infection	28 Participants	16 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Nasopharyngitis	22 Participants	16 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Anaemia	15 Participants	15 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Cough	15 Participants	10 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Pyrexia	15 Participants	7 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Hyperglycaemia	13 Participants	10 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Hyperkalaemia	12 Participants	2 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Urinary tract infection	12 Participants	13 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Diabetes mellitus	10 Participants	5 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Pneumonia	10 Participants	4 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Coronary artery disease	9 Participants	5 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Hyperlipidaemia	9 Participants	8 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Hyperuricaemia	9 Participants	4 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Chronic kidney disease	8 Participants	5 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Depression	8 Participants	3 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Blood glucose increased	7 Participants	5 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Hypercholesterolaemia	7 Participants	5 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Nausea	7 Participants	6 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Type 2 diabetes mellitus	7 Participants	6 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Arthralgia	5 Participants	7 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Influenza	5 Participants	8 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term -Vomiting	5 Participants	9 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Diabetic neuropathy	2 Participants	10 Participants
Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term Diabetic foot	1 Participants	7 Participants

POST_HOC outcome

Timeframe: On-treatment - within 30 days after last treatment, up to Week 96; Post-treatment - greater than 30 days after last treatment, also up to Week 96.

On-treatment deaths are reported from first dose of study treatment until end of study treatment at the time of the interim analysis, plus 4 weeks post treatment, up to a maximum timeframe of approximately 96 weeks. Post-treatment deaths are reported for the timeframe of greater than 30 days after last treatment, also up to Week 96. All deaths refer to the sum of on-treatment and post-treatment deaths.

Outcome measures

Outcome data not reported

Adverse Events

Brolucizumab 6mg

Serious events: 96 serious events

Other events: 241 other events

Deaths: 8 deaths

Panretinal Photocoagulation Laser Arm

Serious events: 105 serious events

Other events: 254 other events

Deaths: 9 deaths

Overall

Serious events: 201 serious events

Other events: 495 other events

Deaths: 17 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 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 (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER