Ranibizumab Intravitreal Injections Versus Sham Control i... | NCT01976338

Label	Type	Description	Intervention Names
Ranibizumab 0.5 mg	Experimental	PRN Intravitreal injection	Drug: Ranibizumab 0.5 mg
Sham injection	Sham Comparator	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection	Other: Sham injection

Name	Type	Description	Arm Group Labels	Other Names
Ranibizumab 0.5 mg	Drug	intravitreal injection of 0.05 ml	Ranibizumab 0.5 mg

Measure	Description	Time Frame
Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6	Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 6 and compared to Baseline.	Baseline to Month 1 through Month 6

Measure	Description	Time Frame
Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12	Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline	Baseline to Month 1 through Month 12

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Beijing	Beijing Municipality	100191	China
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
31902472	Derived	Wei W, Weisberger A, Zhu L, Cheng Y, Liu C; BLOSSOM Study Group. Efficacy and Safety of Ranibizumab in Asian Patients with Branch Retinal Vein Occlusion: Results from the Randomized BLOSSOM Study. Ophthalmol Retina. 2020 Jan;4(1):57-66. doi: 10.1016/j.oret.2019.08.001. Epub 2019 Aug 13.

ID	Title	Description
FG000	Ranibizumab 0.5 mg	PRN Intravitreal injection
FG001	Sham Injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

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

Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 6 and compared to Baseline.

The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)

Posted

Mean

Standard Deviation

Letters

Baseline to Month 1 through Month 6

ID	Title	Description
OG000	Ranibizumab 0.5 mg	PRN Intravitreal injection
OG001	Sham Injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Units	Counts
Participants	OG000189 OG00193

Title

Denominators

Categories

Title	Measurements
	OG00012.5± 8.34 OG0015.0± 9.18

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 OG001		Cochran-Mantel-Haenszel		<0.001														Superiority or Other

Secondary

Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12

Posted

Mean

Standard Deviation

Letters

Baseline to Month 1 through Month 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg	PRN Intravitreal injection
OG001	Sham Injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Units	Counts
Participants

Secondary

Best Corrected Visual Acuity (BCVA) Change Over Time

Posted

Mean

Standard Deviation

Letters

Month 1 through Month 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg	PRN Intravitreal injection
OG001	Sham Injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Units	Counts
Participants	OG000

Secondary

Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters

Posted

Number

Participants

Baseline to month 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg	PRN Intravitreal injection
OG001	Sham Injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Units	Counts
Participants	OG000

Secondary

Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye

Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.

Posted

Number

Participants

Baseline to 12 months

ID	Title	Description
OG000	Ranibizumab 0.5 mg	PRN Intravitreal injection
OG001	Sham Injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Units	Counts

Secondary

Change in Central-Sub-Field- Thickness (CSFT) Over Time

OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center

Posted

Mean

Standard Deviation

µm

Month 1 to month 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg	PRN Intravitreal injection
OG001	Sham Injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Units	Counts
Participants	OG000

Secondary

Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time

Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes

Posted

Mean

Standard Deviation

mm^2

month 3, 6 and 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg	PRN Intravitreal injection
OG001	Sham Injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Units	Counts
Participants	OG000

Secondary

Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time

Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes

Posted

Mean

Standard Deviation

mm^2

Months 3, 6 and 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg	PRN Intravitreal injection
OG001	Sham Injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Units	Counts
Participants	OG000

Secondary

Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time

Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes

Posted

Mean

Standard Deviation

mm^2

Months 3, 6 and 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg	PRN Intravitreal injection
OG001	Sham Injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Units	Counts
Participants	OG000

Secondary

Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12

The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.

The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n=the number of patients with a value for both baseline and the specific post-baseline visit.

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, months 3, 6 and 12

ID	Title	Description
OG000	Ranibizumab 0.5 mg	PRN Intravitreal injection
OG001	Sham Injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Cardiac failure	Cardiac disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Cardiac valve disease	Cardiac disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Coronary artery disease	Cardiac disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Hyperthyroidism	Endocrine disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Cataract	Eye disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Macular hole	Eye disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Colitis ulcerative	Gastrointestinal disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Cholecystitis chronic	Hepatobiliary disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Pneumonia	Infections and infestations	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Clavicle fracture	Injury, poisoning and procedural complications	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Contusion	Injury, poisoning and procedural complications	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Fibula fracture	Injury, poisoning and procedural complications	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Humerus fracture	Injury, poisoning and procedural complications	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Joint dislocation	Injury, poisoning and procedural complications	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Lower limb fracture	Injury, poisoning and procedural complications	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Tibia fracture	Injury, poisoning and procedural complications	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Ulna fracture	Injury, poisoning and procedural complications	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Cluster headache	Nervous system disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Transient ischaemic attack	Nervous system disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Vertebrobasilar insufficiency	Nervous system disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Haematoma	Vascular disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Hypertension	Vascular disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Leukocytosis	Blood and lymphatic system disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Angina pectoris	Cardiac disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Arteriosclerosis coronary artery	Cardiac disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Coronary artery disease	Cardiac disorders	19.0	Systematic Assessment	EG0004 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Age-related macular degeneration	Eye disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Angle closure glaucoma	Eye disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Cataract	Eye disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Conjunctival deposit	Eye disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Conjunctival haemorrhage	Eye disorders	19.0	Systematic Assessment	EG00020 affected190 at risk EG0014 affected66 at risk EG0020 affected26 at risk
Conjunctivitis allergic	Eye disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Corneal epithelium defect	Eye disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Dry eye	Eye disorders	19.0	Systematic Assessment	EG0003 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Eye irritation	Eye disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0012 affected66 at risk EG0020 affected26 at risk
Eye pain	Eye disorders	19.0	Systematic Assessment	EG00010 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Eye pruritus	Eye disorders	19.0	Systematic Assessment	EG0004 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Eye swelling	Eye disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Eyelid oedema	Eye disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0011 affected66 at risk EG0021 affected26 at risk
Foreign body sensation in eyes	Eye disorders	19.0	Systematic Assessment	EG0006 affected190 at risk EG0011 affected66 at risk EG0021 affected26 at risk
Glare	Eye disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Keratitis	Eye disorders	19.0	Systematic Assessment	EG0003 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Lacrimation increased	Eye disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0012 affected66 at risk EG0020 affected26 at risk
Macular fibrosis	Eye disorders	19.0	Systematic Assessment	EG0006 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Ocular hyperaemia	Eye disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Ocular hypertension	Eye disorders	19.0	Systematic Assessment	EG0003 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Open angle glaucoma	Eye disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Retinal fibrosis	Eye disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Retinal haemorrhage	Eye disorders	19.0	Systematic Assessment	EG0003 affected190 at risk EG0013 affected66 at risk EG0020 affected26 at risk
Retinal ischaemia	Eye disorders	19.0	Systematic Assessment	EG0007 affected190 at risk EG0013 affected66 at risk EG0021 affected26 at risk
Retinal neovascularisation	Eye disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Retinal vein occlusion	Eye disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Vision blurred	Eye disorders	19.0	Systematic Assessment	EG0003 affected190 at risk EG0012 affected66 at risk EG0020 affected26 at risk
Visual acuity reduced	Eye disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0012 affected66 at risk EG0020 affected26 at risk
Vitreous detachment	Eye disorders	19.0	Systematic Assessment	EG0003 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Vitreous floaters	Eye disorders	19.0	Systematic Assessment	EG0004 affected190 at risk EG0012 affected66 at risk EG0020 affected26 at risk
Vitreous haemorrhage	Eye disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Vitreous opacities	Eye disorders	19.0	Systematic Assessment	EG0003 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Abdominal distension	Gastrointestinal disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0011 affected66 at risk EG0021 affected26 at risk
Abdominal pain upper	Gastrointestinal disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Chronic gastritis	Gastrointestinal disorders	19.0	Systematic Assessment	EG0003 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Diarrhoea	Gastrointestinal disorders	19.0	Systematic Assessment	EG0004 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Gastritis	Gastrointestinal disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Mouth ulceration	Gastrointestinal disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Nausea	Gastrointestinal disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Toothache	Gastrointestinal disorders	19.0	Systematic Assessment	EG0006 affected190 at risk EG0012 affected66 at risk EG0021 affected26 at risk
Peripheral swelling	General disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Pyrexia	General disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Hepatic function abnormal	Hepatobiliary disorders	19.0	Systematic Assessment	EG0003 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Conjunctivitis	Infections and infestations	19.0	Systematic Assessment	EG0005 affected190 at risk EG0011 affected66 at risk EG0021 affected26 at risk
Gingivitis	Infections and infestations	19.0	Systematic Assessment	EG0000 affected190 at risk EG0012 affected66 at risk EG0020 affected26 at risk
Nasopharyngitis	Infections and infestations	19.0	Systematic Assessment	EG00023 affected190 at risk EG0018 affected66 at risk EG0023 affected26 at risk
Otitis media acute	Infections and infestations	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Periodontitis	Infections and infestations	19.0	Systematic Assessment	EG0001 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Pharyngitis	Infections and infestations	19.0	Systematic Assessment	EG0001 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Tooth abscess	Infections and infestations	19.0	Systematic Assessment	EG0001 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Upper respiratory tract infection	Infections and infestations	19.0	Systematic Assessment	EG00010 affected190 at risk EG0011 affected66 at risk EG0021 affected26 at risk
Urinary tract infection	Infections and infestations	19.0	Systematic Assessment	EG0002 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Animal bite	Injury, poisoning and procedural complications	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Conjunctival abrasion	Injury, poisoning and procedural complications	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Ligament sprain	Injury, poisoning and procedural complications	19.0	Systematic Assessment	EG0003 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Activated partial thromboplastin time prolonged	Investigations	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Blood glucose increased	Investigations	19.0	Systematic Assessment	EG0002 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Blood pressure increased	Investigations	19.0	Systematic Assessment	EG0003 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Glucose urine present	Investigations	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Haemoglobin urine present	Investigations	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Hepatic enzyme increased	Investigations	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Intraocular pressure increased	Investigations	19.0	Systematic Assessment	EG00010 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Optic nerve cup/disc ratio increased	Investigations	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Platelet count decreased	Investigations	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Platelet count increased	Investigations	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Protein urine present	Investigations	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Visual acuity tests abnormal	Investigations	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Weight decreased	Investigations	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Diabetes mellitus	Metabolism and nutrition disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Gout	Metabolism and nutrition disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Hypoglycaemia	Metabolism and nutrition disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	19.0	Systematic Assessment	EG0006 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Back pain	Musculoskeletal and connective tissue disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Fasciitis	Musculoskeletal and connective tissue disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	19.0	Systematic Assessment	EG0004 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0010 affected66 at risk EG0022 affected26 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	19.0	Systematic Assessment	EG0000 affected190 at risk EG0010 affected66 at risk EG0021 affected26 at risk
Balance disorder	Nervous system disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Dizziness	Nervous system disorders	19.0	Systematic Assessment	EG0006 affected190 at risk EG0012 affected66 at risk EG0020 affected26 at risk
Headache	Nervous system disorders	19.0	Systematic Assessment	EG00011 affected190 at risk EG0012 affected66 at risk EG0020 affected26 at risk
Syncope	Nervous system disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Insomnia	Psychiatric disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0013 affected66 at risk EG0020 affected26 at risk
Breast cyst	Reproductive system and breast disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Cough	Respiratory, thoracic and mediastinal disorders	19.0	Systematic Assessment	EG0009 affected190 at risk EG0012 affected66 at risk EG0023 affected26 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	19.0	Systematic Assessment	EG0004 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0012 affected66 at risk EG0020 affected26 at risk
Eczema	Skin and subcutaneous tissue disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0021 affected26 at risk
Rash	Skin and subcutaneous tissue disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Urticaria	Skin and subcutaneous tissue disorders	19.0	Systematic Assessment	EG0001 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Urticaria papular	Skin and subcutaneous tissue disorders	19.0	Systematic Assessment	EG0000 affected190 at risk EG0011 affected66 at risk EG0020 affected26 at risk
Aortic arteriosclerosis	Vascular disorders	19.0	Systematic Assessment	EG0002 affected190 at risk EG0010 affected66 at risk EG0020 affected26 at risk
Hypertension	Vascular disorders	19.0	Systematic Assessment	EG00016 affected190 at risk EG0018 affected66 at risk EG0024 affected26 at risk

ID	Term
D008269	Macular Edema
D014786	Vision Disorders
D012170	Retinal Vein Occlusion

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D020246	Venous Thrombosis
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

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	Ranibizumab 0.5 mg	PRN Intravitreal injection
BG001	Sham Injection	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ranibizumab 0.5 mg	PRN Intravitreal injection	13	190	119	190
EG001	Sham With Ranibizumab 0.5 mg	As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection	3	66	46	66
EG002	Sham Without Ranibizumab 0.5 mg	sham + ranibizumab 0.5 mg PRN as of Month 6 (hereafter referred to as sham group up to Month 6 and sham with ranibizumab or sham without ranibizumab after Month 6)	3	26	14	26