OPT-302 With Ranibizumab in Neovascular Age-related Macul... | NCT04757610

Label	Type	Description	Intervention Names
0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302	Experimental	0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.	Biological: 2.0 mg OPT-302 Biological: 0.5 mg ranibizumab
0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302	Experimental	0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.	Biological: 2.0 mg OPT-302 Biological: 0.5 mg ranibizumab
0.5 mg ranibizumab with sham	Sham Comparator	0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.	Biological: 0.5 mg ranibizumab Procedure: Sham

Name	Type	Description	Arm Group Labels	Other Names
2.0 mg OPT-302	Biological	intravitreal injection	0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302

Measure	Description	Time Frame
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters	To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome measure means a deterioration in ETDRS BCVA letter score from baseline)	Baseline to Week 52

Measure	Description	Time Frame
Participants Gaining 15 or More ETDRS BCVA Letters	To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 15 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52.	Baseline to Week 52

Facility	Status	City	State	ZIP	Country	Contacts
ShORe Investigational Site		Phoenix	Arizona	85016	United States
ShORe Investigational Site

ID	Title	Description
FG000	0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 19, 2023	Jul 17, 2025

Type

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Description

Population Description

Reporting Status

Anticipated Posting Date

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Units Analyzed

Denominator Units Selected

Arm/Group Information

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Analyses

Primary

Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters

To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome measure means a deterioration in ETDRS BCVA letter score from baseline)

Modified Intent-to-Treat (mITT) analysis set - comprised all randomised participants with at least one dose of study medication. Participants were analysed according to the study medication to which they were randomised for all efficacy analyses.

Posted

Least Squares Mean

Standard Error

Letters read

Baseline to Week 52

ID	Title	Description
OG000	0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection
OG001	0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection Sham: intravitreal injection
OG002	0.5 mg Ranibizumab With Sham	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96. 0.5 mg ranibizumab: intravitreal injection Sham: intravitreal injection

Units	Counts
Participants	OG000328 OG001326 OG002331

Title

Denominators

Categories

Title	Measurements
	OG00013.20± 0.728 OG00112.41± 0.731 OG00214.30± 0.719

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		MMRM		0.284421		Least Squares Mean Difference	-1.10	Standard Error of the Mean	1.023	2-Sided	95	-3.10	0.91					Superiority
OG001 OG002		MMRM		0.066678

Secondary

Participants Gaining 15 or More ETDRS BCVA Letters

To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 15 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52.

Posted

Count of Participants

Participants

Baseline to Week 52

ID	Title	Description
OG000	0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection
OG001	0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection Sham: intravitreal injection

Secondary

Participants Gaining 10 More ETDRS BCVA Letters

To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 10 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52.

Posted

Count of Participants

Participants

Baseline to Week 52

ID	Title	Description
OG000	0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection
OG001	0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection Sham: intravitreal injection

Secondary

Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)

To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in CNV area as measured by FA in the study eye from Baseline to Week 52.

Posted

Mean

Standard Error

mm^2

Baseline to Week 52

ID	Title	Description
OG000	0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection
OG001	0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection Sham: intravitreal injection

Secondary

Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT

To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT in the study eye at Week 52.

Posted

Count of Participants

Participants

at Week 52

ID	Title	Description
OG000	0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection
OG001	0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection Sham: intravitreal injection

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Cataract	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0003 events3 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Angle closure glaucoma	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Retinal detachment	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Retinal artery embolism	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Retinal haemorrhage	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Vitritis	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Retinal pigment epithelial tear	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0021 events1 affected330 at risk
Eye inflammation	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Optic neuropathy	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Retinal tear	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Visual acuity reduced	Eye disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Endophthalmitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	Includes 1 non-study eye event in the Standard Dosing arm	EG0004 events4 affected328 at risk EG0011 events1 affected327 at risk EG0021 events1 affected330 at risk
Glaucoma	Eye disorders	MedDRA 27.0	Systematic Assessment	Non-study eye event	EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment		EG0002 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0003 events3 affected328 at risk EG0013 events2 affected327 at risk EG0022 events2 affected330 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0014 events3 affected327 at risk EG0021 events1 affected330 at risk
Coronary artery disease	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0017 events6 affected327 at risk EG0022 events2 affected330 at risk
Myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0012 events2 affected327 at risk EG0021 events1 affected330 at risk
Atrial flutter	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Cardiac failure	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Angina unstable	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Pericarditis	Cardiac disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Colitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0021 events1 affected330 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0021 events1 affected330 at risk
Abdominal compartment syndrome	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Enterocele	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Pancreatic mass	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Mesenteric arterial occlusion	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Death	General disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0011 events1 affected327 at risk EG0021 events1 affected330 at risk
Asthenia	General disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
General physical health deterioration	General disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Gait disturbance	General disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0011 events1 affected327 at risk EG0021 events1 affected330 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Cholelithiasis obstructive	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0013 events3 affected327 at risk EG0022 events2 affected330 at risk
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
COVID-19 Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0012 events2 affected327 at risk EG0022 events2 affected330 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Septic shock	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Diverticulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0021 events1 affected330 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0021 events1 affected330 at risk
Appendicitis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Erysipelas	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Klebsiella urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Medical device site infection	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Skin bacterial infection	Infections and infestations	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0004 events4 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0013 events3 affected327 at risk EG0022 events2 affected330 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Craniofacial fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0002 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Femure fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0021 events1 affected330 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Carotid artery restenosis	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Type I diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0021 events1 affected330 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Marginal zone lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Colorectal cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Cutaneous T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Endometrial cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0012 events2 affected327 at risk EG0023 events3 affected330 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0012 events1 affected327 at risk EG0020 events0 affected330 at risk
Ataxia	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Radiculopathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Cerebral thrombosis	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Nerve compression	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Neurodegenerative disorder	Nervous system disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Rapid eye movement sleep behaviour disorder	Psychiatric disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0012 events2 affected327 at risk EG0020 events0 affected330 at risk
Haematuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0012 events2 affected327 at risk EG0020 events0 affected330 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0002 events2 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Pneumonitis aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Pulmonary amyloidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Haematoma	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0001 events1 affected328 at risk EG0010 events0 affected327 at risk EG0020 events0 affected330 at risk
Aortic stenosis	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Hypertensive crisis	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0011 events1 affected327 at risk EG0020 events0 affected330 at risk
Hypertensive urgency	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Peripheral venous disease	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk
Venous hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected328 at risk EG0010 events0 affected327 at risk EG0021 events1 affected330 at risk

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

ID	Title	Description
BG000	0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection
BG001	0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection Sham: intravitreal injection
BG002	0.5 mg Ranibizumab With Sham	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96. 0.5 mg ranibizumab: intravitreal injection Sham: intravitreal injection
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection	5	328	65	328	290	328
EG001	0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered. 2.0 mg OPT-302: intravitreal injection 0.5 mg ranibizumab: intravitreal injection Sham: intravitreal injection	13	327	60	327	261	327
EG002	0.5 mg Ranibizumab With Sham	0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96. 0.5 mg ranibizumab: intravitreal injection Sham: intravitreal injection	8	330	52	330	265	330