A Depot Formulation of Sunitinib Malate (GB-102) Compared... | NCT03953079

Label	Type	Description	Intervention Names
GB-102 1 mg/1 mg	Experimental	Participants will receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.	Drug: Drug: GB-102
GB-102 2 mg/1 mg	Experimental	Participants will receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.	Drug: Drug: GB-102
Aflibercept 2 mg	Active Comparator	Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.	Drug: Aflibercept

Name	Type	Description	Arm Group Labels	Other Names
Drug: GB-102	Drug	Intravitreal injection of GB-102	GB-102 1 mg/1 mg GB-102 2 mg/1 mg

Measure	Description	Time Frame
Time to First Rescue Treatment	Kaplan-Meier estimate of the median time to first rescue treatment.	Baseline through 12 months

Measure	Description	Time Frame
Time to Fulfillment of at Least One Rescue Criterion	Assessment of time to fulfillment of at least one rescue criterion starting at the Month 6 visit through to the Month 12 visit	6 months through 12 months
Number of Times That at Least One Rescue Criterion is Met

Name	Affiliation	Role
Chief Medical Officer	Graybug Vision, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Retinal Consultants AZ		Gilbert	Arizona	85296	United States
Retinal Research Institute

ID	Title	Description
FG000	GB-102 1 mg/1 mg	Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
FG001	GB-102 2 mg/1 mg	Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 8, 2020	Nov 10, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to First Rescue Treatment

Kaplan-Meier estimate of the median time to first rescue treatment.

Posted

Median

80% Confidence Interval

months

Baseline through 12 months

ID	Title	Description
OG000	GB-102 1 mg/1 mg	Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
OG001	GB-102 2 mg/1 mg	Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
OG002	Aflibercept 2 mg	Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Units	Counts
Participants	OG00021 OG00122 OG00213

Title

Denominators

Categories

Title	Measurements
	OG0005(3 to 8) OG0014(3 to 4) OG002NA(NA to NA)NA = not applicable/ not estimable due to small sample size and insufficient number of participants who needed rescue treatment.

Secondary

Time to Fulfillment of at Least One Rescue Criterion

Assessment of time to fulfillment of at least one rescue criterion starting at the Month 6 visit through to the Month 12 visit

Full Analysis Set which include all randomized subjects who received at least one dose of study treatment and complete a baseline and at least one post-baseline visit.

Posted

Median

80% Confidence Interval

months

6 months through 12 months

ID	Title	Description
OG000	GB-102 1 mg/1 mg	Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
OG001	GB-102 2 mg/1 mg	Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
OG002	Aflibercept 2 mg	Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Units	Counts

Secondary

Number of Times That at Least One Rescue Criterion is Met

Assessment of the number of monthly intervals that at least one rescue criterion is met

The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.

Posted

Mean

Standard Error

total monthly interval

Baseline through 12 months

ID	Title	Description
OG000	GB-102 1 mg/1 mg	Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
OG001	GB-102 2 mg/1 mg	Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
OG002	Aflibercept 2 mg	Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Units	Counts

Secondary

Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study

Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study

The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.

Posted

Median

Full Range

Injections

Baseline through 12 months

ID	Title	Description
OG000	GB-102 1 mg/1 mg	Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
OG001	GB-102 2 mg/1 mg	Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
OG002	Aflibercept 2 mg	Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Secondary

Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits

BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy

BCVA ETDRS range = 0 (worst) to 100 (best)

Assessment of change in BCVA (ETDRS letter score) from baseline at all visits

The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.

Posted

Mean

Standard Deviation

letters

Baseline through 12 months

ID	Title	Description
OG000	GB-102 1 mg/1 mg	Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
OG001	GB-102 2 mg/1 mg	Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
OG002	Dose	Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Secondary

Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits

BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy

BCVA ETDRS range = 0 (worst) to 100 (best)

Assessment of categorical change in BCVA (ETDRS letter score) from baseline at all visits

The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.

Posted

Count of Participants

Participants

Baseline through 12 months

ID	Title	Description
OG000	GB-102 1 mg/1 mg	Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
OG001	GB-102 2 mg/1 mg	Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
OG002	Aflibercept 2 mg	Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Secondary

Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits

Assessment of the frequency of subjects with BCVA worse than 20/200 (Snellen equivalent) at all visits

A vision score of 20/20 is considered normal. A vision score of 20/200 is considered legally blind.

The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.

Posted

Count of Participants

Participants

Baseline through 12 months

ID	Title	Description
OG000	GB-102 1 mg/1 mg	Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
OG001	GB-102 2 mg/1 mg	Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
OG002	Aflibercept 2 mg	Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Secondary

Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits

CST = central subfield thickness

Assessment of change in CST (μm) measurement from baseline at all visits

The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.

Posted

Mean

Standard Deviation

microns

Baseline through 12 months

ID	Title	Description
OG000	GB-102 1 mg/1 mg	Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
OG001	GB-102 2 mg/1 mg	Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
OG002	Aflibercept 2 mg	Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Units

Secondary

Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits

Assessment of the frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at all visits

The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.

Posted

Count of Participants

Participants

Baseline through 12 months

ID	Title	Description
OG000	GB-102 1 mg/1 mg	Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
OG001	GB-102 2 mg/1 mg	Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
OG002	Aflibercept 2 mg	Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vitreous floaters	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0008 events6 affected21 at risk EG00113 events10 affected22 at risk EG0022 events2 affected13 at risk
Iritis	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0006 events5 affected21 at risk EG00111 events10 affected22 at risk EG0020 events0 affected13 at risk
Retinal haemorrhage	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0004 events4 affected21 at risk EG0014 events4 affected22 at risk EG0021 events1 affected13 at risk
Visual acuity reduced	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0004 events3 affected21 at risk EG0014 events4 affected22 at risk EG0020 events0 affected13 at risk
Subretinal fluid	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events2 affected21 at risk EG0012 events2 affected22 at risk EG0021 events1 affected13 at risk
Eye pain	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0016 events5 affected22 at risk EG0021 events1 affected13 at risk
Cataract	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0004 events2 affected21 at risk EG0013 events3 affected22 at risk EG0020 events0 affected13 at risk
Visual impairment	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0013 events2 affected22 at risk EG0020 events0 affected13 at risk
Posterior capsule opacification	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0011 events1 affected22 at risk EG0022 events1 affected13 at risk
Vitritis	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Subretinal fibrosis	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Retinal oedema	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Retinal thickening	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Uveitis	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Vision blurred	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events2 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Vitreous detachment	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events1 affected21 at risk EG0010 events0 affected22 at risk EG0022 events1 affected13 at risk
Episcleritis	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0013 events3 affected22 at risk EG0020 events0 affected13 at risk
Dry eye	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0012 events2 affected22 at risk EG0022 events1 affected13 at risk
Anterior chamber inflammation	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0013 events2 affected22 at risk EG0020 events0 affected13 at risk
Cataract subcapsular	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0012 events2 affected22 at risk EG0020 events0 affected13 at risk
Corneal oedema	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0013 events2 affected22 at risk EG0020 events0 affected13 at risk
Keratic precipitates	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0014 events2 affected22 at risk EG0020 events0 affected13 at risk
Photophobia	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0013 events2 affected22 at risk EG0020 events0 affected13 at risk
Choroidal neovascularisation	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Dermatochalasis	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Eye allergy	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Iris adhesions	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Papilloedema	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Punctate keratitis	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Scleritis	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Vitreous degeneration	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Neovascular age-related macular degeneration	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0023 events2 affected13 at risk
Subretinal hyperreflective exudation	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk
Product residue present	Investigations	MedDRA (23.0)	Systematic Assessment	EG0004 events4 affected21 at risk EG0017 events6 affected22 at risk EG0020 events0 affected13 at risk
Intraocular pressure increased	Investigations	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0014 events1 affected22 at risk EG0020 events0 affected13 at risk
Optical coherence tomography abnormal	Investigations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Conjunctivitis	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0002 events2 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Hordeolum	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0021 events1 affected13 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Arteriosclerosis	Vascular disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Nasopharyngitis	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0003 events3 affected21 at risk EG0011 events1 affected22 at risk EG0022 events2 affected13 at risk
Sinusitis	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0013 events3 affected22 at risk EG0020 events0 affected13 at risk
Urinary tract infection	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0011 events1 affected22 at risk EG0021 events1 affected13 at risk
Asymptomatic COVID-19	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Infected dermal cyst	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Pneumonia	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Cystitis	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk
Gingival abscess	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events2 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events1 affected21 at risk EG0010 events0 affected22 at risk EG0022 events1 affected13 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0012 events2 affected22 at risk EG0020 events0 affected13 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk
Dementia	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0002 events2 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Sinus headache	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Headache	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0013 events3 affected22 at risk EG0020 events0 affected13 at risk
Syncope	Nervous system disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk
Insomnia	Psychiatric disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Delirium	Psychiatric disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Hypertension	Vascular disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0012 events2 affected22 at risk EG0020 events0 affected13 at risk
Aortic stenosis	Vascular disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Loose tooth	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Localised oedema	General disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Seasonal allergy	Immune system disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Blood pressure increased	Investigations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Herpes zoster	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Pyelonephritis	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Constipation	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Hypothermia	General disorders	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Abdominal wall neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Lens discolouration	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Dry age-related macular degeneration	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk

ID	Term
D008268	Macular Degeneration
D020256	Choroidal Neovascularization

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015862	Choroid Diseases
D014603	Uveal Diseases
D009389	Neovascularization, Pathologic
D008679	Metaplasia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	GB-102 1 mg/1 mg	Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
BG001	GB-102 2 mg/1 mg	Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
BG002	Aflibercept 2 mg	Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	GB-102 1 mg/1 mg	Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.	21	2	21	20	21
EG001	GB-102 2 mg/1 mg	Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.	22	4	22	22	22
EG002	Aflibercept 2 mg	Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.	13	1	13	8	13

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Retinal detachment	Eye disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Pneumonia	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Acute myeloid leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Sepsis	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected21 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk
Urosepsis	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected21 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk