Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combi... | NCT00492284

Label	Type	Description	Intervention Names
1/4 Fluence Triple Therapy	Experimental	Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter	Drug: verteporfin Drug: ranibizumab Drug: dexamethasone
1/2 Fluence Triple Therapy	Experimental	Reduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter	Drug: verteporfin Drug: ranibizumab Drug: dexamethasone
1/2 Fluence Double Therapy	Experimental	Reduced-fluence Visudyne followed by Lucentis double therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter	Drug: verteporfin Drug: ranibizumab
Ranibizumab	Experimental	Lucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter	Drug: ranibizumab

Name	Type	Description	Arm Group Labels	Other Names
verteporfin	Drug	Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)	1/2 Fluence Double Therapy 1/2 Fluence Triple Therapy

Measure	Description	Time Frame
Mean Number of Retreatments (Day 0 Excluded)	Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.	Month 1 to Month 12
Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)	Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100	Baseline to Month 12

Measure	Description	Time Frame
Mean Number of Retreatments (Day 0 Excluded)	Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.

Name	Affiliation	Role
Henry Hudson, MD	Retina Centers, PC	Principal Investigator
Allen Ho, MD	Retina Diagnostic & Treatment Associates, LLC	Principal Investigator
Andrew Strong, Ph.D	QLT Inc.	Study Chair
Oscar Cuzzani, MD	QLT Inc.	Study Director

ID	Title	Description
FG000	1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
FG001	1/2 Fluence Triple Therapy

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

Mean Number of Retreatments (Day 0 Excluded)

Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.

Intent-to-treat

Posted

Mean

95% Confidence Interval

number of retreatments

Month 1 to Month 12

ID	Title	Description
OG000	1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG001	1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG002	1/2 Fluence Double Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
OG003	Ranibizumab	Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter

Units	Counts
Participants	OG00039 OG00139 OG00243 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003.97± 3.12(2.96 to 4.98) OG0013.00± 2.55(2.17 to 3.83) OG0024.05± 2.93(3.15 to 4.95)

Primary

Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)

Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100

Intent-to-treat and last observation carried forward

Posted

Mean

95% Confidence Interval

Letters read on ETDRS chart

Baseline to Month 12

ID	Title	Description
OG000	1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG001	1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG002	1/2 Fluence Double Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
OG003	Ranibizumab

Secondary

Mean Number of Retreatments (Day 0 Excluded)

Intent-to-treat

Posted

Mean

95% Confidence Interval

number of retreatments

Month 1 to Month 24

ID	Title	Description
OG000	1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG001	1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG002	1/2 Fluence Double Therapy

Secondary

Mean Change From Baseline in Study Eye Best-Corrected VA Score

Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100

Posted

Mean

95% Confidence Interval

Letters read on ETDRS chart

Baseline to Month 24

ID	Title	Description
OG000	1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG001	1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG002	1/2 Fluence Double Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
OG003	Ranibizumab	Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter

Secondary

Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline

Intent-to-treat and last observation carried forward

Posted

Mean

95% Confidence Interval

Percentage of participants

Baseline to Month 12, Baseline to Month 24

ID	Title	Description
OG000	1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG001	1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG002	1/2 Fluence Double Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
OG003	Ranibizumab	Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter

Secondary

Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline

Intent-to-treat and last observation carried forward

Posted

Mean

95% Confidence Interval

Percentage of participants

Baseline to Month 12, Baseline to Month 24

ID	Title	Description
OG000	1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG001	1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG002	1/2 Fluence Double Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
OG003	Ranibizumab	Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter

Secondary

Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline

Intent-to-treat and last observation carried forward

Posted

Mean

95% Confidence Interval

Percentage of participants

Baseline to Month 12, Baseline to Month 24

ID	Title	Description
OG000	1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG001	1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG002	1/2 Fluence Double Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
OG003	Ranibizumab	Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter

Secondary

Mean Change From Baseline in Central Retinal Thickness

Intent-to-treat and last observation carried forward

Posted

Mean

Standard Deviation

micron

Baseline to Month 12, Baseline to Month 24

ID	Title	Description
OG000	1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG001	1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG002	1/2 Fluence Double Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
OG003	Ranibizumab	Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter

Secondary

Mean Change From Baseline in Lesion Size

Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion

Intent-to-treat and last observation carried forward

Posted

Mean

Standard Deviation

micron

Baseline to Month 12, Baseline to Month 24

ID	Title	Description
OG000	1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG001	1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
OG002	1/2 Fluence Double Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
OG003	Ranibizumab

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
AV block complete	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG0031 events1 affected41 at risk
AV block second degree	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Abdominal Pain	General disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Accidental Injury	General disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events2 affected39 at risk EG0021 events1 affected43 at risk EG003
Acute kidney failure	Renal and urinary disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0013 events2 affected39 at risk EG0020 events0 affected43 at risk EG003
Anaphylactoid Reaction	General disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Angina pectoris	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events2 affected39 at risk EG0021 events1 affected43 at risk EG003
Aplastic anemia	Blood and lymphatic system disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Arrhythmia	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Arteriosclerosis	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Aspiration pneumonia	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Atrial fibrillation	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0021 events1 affected43 at risk EG003
Breast carcinoma	Reproductive system and breast disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Bundle Branch Block	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Cardiovascular disorder	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0021 events1 affected43 at risk EG003
Cellulitis	General disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0021 events1 affected43 at risk EG003
Cerebral infarct	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Cerebrovascular accident	Nervous system disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Chest pain	General disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0021 events1 affected43 at risk EG003
Cholecystitis	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Cholelithiasis	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Colitis	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Congestive Heart Failure	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events2 affected39 at risk EG0021 events1 affected43 at risk EG003
Death	General disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Dehydration	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0021 events1 affected43 at risk EG003
Diabetes Mellitus	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Dizziness	Nervous system disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Endocarditis	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Gastrointestinal carcinoma	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0022 events2 affected43 at risk EG003
Gastrointestinal hemorrhage	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0022 events2 affected43 at risk EG003
Gastrointestinal neoplasia	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Healing abnormal	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Heart arrest	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Hernia	General disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Hypertension	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Hypotension	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Hypoxia	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Increased intraocular pressure (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Infection	General disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Infection bacterial	General disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Intestinal perforation	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Kidney failure	Renal and urinary disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Lung edema	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Neck pain	General disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Pain	General disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Pancreatitis	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Pathological Fracture	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Pneumonia	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0013 events3 affected39 at risk EG0020 events0 affected43 at risk EG003
Postural Hypotension	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Psychosis	Nervous system disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Pyogenic arthritis	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Retinal detachment (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Retinal tear (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Sepsis	General disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events2 affected39 at risk EG0020 events0 affected43 at risk EG003
Syncope	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events2 affected39 at risk EG0020 events0 affected43 at risk EG003
Tachycardia	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Thinking abnormal	Nervous system disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Vascular anomaly	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Vertigo	Nervous system disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Viral infection	General disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Vision decreased (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected39 at risk EG0021 events1 affected43 at risk EG003
Visual field defect (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Vitreous hemorrhage (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Cardiomyopathy	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Coronary artery disorder	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Peripheral vascular disorder	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Pulmonary embolus	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Ventricular tachycardia	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Cholangitis	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Liver damage	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Adrenal disorder	Endocrine disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Anemia	Blood and lymphatic system disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Blood dyscrasia	Blood and lymphatic system disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Hypomagnesemia	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Bone neoplasm	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Confusion	Nervous system disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Convulsion	Nervous system disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Apnea	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Accidental Injury	General disorders	COSTART	Systematic Assessment	EG00011 events6 affected39 at risk EG0019 events5 affected39 at risk EG00211 events7 affected43 at risk EG00315 events9 affected41 at risk
Age-related Macular Degeneration progression (fellow eye)	Eye disorders	COSTART	Systematic Assessment	EG0003 events3 affected39 at risk EG0018 events8 affected39 at risk EG0021 events1 affected43 at risk EG003
Anemia	Blood and lymphatic system disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0013 events3 affected39 at risk EG0022 events2 affected43 at risk EG003
Anxiety	Nervous system disorders	COSTART	Systematic Assessment	EG0003 events3 affected39 at risk EG0010 events0 affected39 at risk EG0022 events2 affected43 at risk EG003
Asthenia	General disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0015 events4 affected39 at risk EG0027 events5 affected43 at risk EG003
Back pain	General disorders	COSTART	Systematic Assessment	EG0004 events4 affected39 at risk EG0012 events2 affected39 at risk EG0020 events0 affected43 at risk EG003
Blepharitis (fellow eye)	Eye disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0014 events4 affected39 at risk EG0020 events0 affected43 at risk EG003
Blepharitis (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0014 events4 affected39 at risk EG0021 events1 affected43 at risk EG003
Bronchitis	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0003 events3 affected39 at risk EG0014 events4 affected39 at risk EG0022 events2 affected43 at risk EG003
Cataract (fellow eye)	Eye disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0014 events4 affected39 at risk EG0022 events2 affected43 at risk EG003
Cataract (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0014 events4 affected39 at risk EG0026 events6 affected43 at risk EG003
Chest pain	General disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0011 events1 affected39 at risk EG0022 events2 affected43 at risk EG003
Cholelithiasis	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Conjunctivitis (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0004 events2 affected39 at risk EG0013 events3 affected39 at risk EG0022 events2 affected43 at risk EG003
Corneal lesion (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0013 events3 affected39 at risk EG0020 events0 affected43 at risk EG003
Cough increased	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0012 events2 affected39 at risk EG0026 events6 affected43 at risk EG003
Dehydration	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0014 events4 affected39 at risk EG0022 events2 affected43 at risk EG003
Dizziness	Nervous system disorders	COSTART	Systematic Assessment	EG0004 events4 affected39 at risk EG0015 events5 affected39 at risk EG0021 events1 affected43 at risk EG003
Ecchymosis	Blood and lymphatic system disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0013 events3 affected39 at risk EG0023 events2 affected43 at risk EG003
Eye itching (fellow eye)	Eye disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0013 events3 affected39 at risk EG0020 events0 affected43 at risk EG003
Eye itching (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0013 events3 affected39 at risk EG0021 events1 affected43 at risk EG003
Eye pain (study eye)	Eye disorders	COSTART	Systematic Assessment	EG00015 events7 affected39 at risk EG00111 events9 affected39 at risk EG00215 events9 affected43 at risk EG003
Flu syndrome	General disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0012 events2 affected39 at risk EG0020 events0 affected43 at risk EG003
Headache	General disorders	COSTART	Systematic Assessment	EG0004 events3 affected39 at risk EG0012 events1 affected39 at risk EG0024 events4 affected43 at risk EG003
Hypercholesterolemia	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected39 at risk EG0023 events3 affected43 at risk EG003
Hyperlipemia	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0013 events3 affected39 at risk EG0021 events1 affected43 at risk EG003
Hypertension	Cardiac disorders	COSTART	Systematic Assessment	EG0009 events7 affected39 at risk EG0012 events2 affected39 at risk EG0027 events7 affected43 at risk EG003
Increased intraocular pressure (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0004 events4 affected39 at risk EG00112 events4 affected39 at risk EG0028 events6 affected43 at risk EG003
Infection	General disorders	COSTART	Systematic Assessment	EG0009 events7 affected39 at risk EG0019 events7 affected39 at risk EG0028 events5 affected43 at risk EG003
Infusion-related back pain	General disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0015 events2 affected39 at risk EG0028 events4 affected43 at risk EG003
Injection site pain	General disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected39 at risk EG0024 events3 affected43 at risk EG003
Nausea	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0013 events3 affected39 at risk EG0024 events4 affected43 at risk EG003
Pain	General disorders	COSTART	Systematic Assessment	EG0003 events3 affected39 at risk EG0014 events4 affected39 at risk EG0024 events4 affected43 at risk EG003
Peripheral edema	Metabolism and nutrition disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0013 events3 affected39 at risk EG0022 events2 affected43 at risk EG003
Peripheral vascular disorder	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0023 events3 affected43 at risk EG003
Pneumonia	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0002 events1 affected39 at risk EG0013 events3 affected39 at risk EG0020 events0 affected43 at risk EG003
Syncope	Cardiac disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0015 events5 affected39 at risk EG0022 events2 affected43 at risk EG003
Urinary tract infection	Renal and urinary disorders	COSTART	Systematic Assessment	EG0008 events2 affected39 at risk EG0013 events3 affected39 at risk EG0024 events4 affected43 at risk EG003
Vision abnormal (study eye)	Eye disorders	COSTART	Systematic Assessment	EG00010 events8 affected39 at risk EG0011 events1 affected39 at risk EG00210 events7 affected43 at risk EG003
Vision decreased (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0006 events5 affected39 at risk EG0014 events4 affected39 at risk EG0028 events6 affected43 at risk EG003
Visual field defect (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0005 events5 affected39 at risk EG0010 events0 affected39 at risk EG0022 events2 affected43 at risk EG003
Vitreous disorder (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0004 events4 affected39 at risk EG0012 events2 affected39 at risk EG0023 events3 affected43 at risk EG003
Abdominal pain	General disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected39 at risk EG0022 events2 affected43 at risk EG003
Allergic reaction	General disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0012 events2 affected39 at risk EG0021 events1 affected43 at risk EG003
Injection site extravasation	General disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0011 events1 affected39 at risk EG0023 events3 affected43 at risk EG003
Bradycardia	Cardiac disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0011 events1 affected39 at risk EG0021 events1 affected43 at risk EG003
Cardiovascular disorder	Cardiac disorders	COSTART	Systematic Assessment	EG0003 events2 affected39 at risk EG0010 events0 affected39 at risk EG0025 events2 affected43 at risk EG003
Cerebral ischemia	Cardiac disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0013 events3 affected39 at risk EG0020 events0 affected43 at risk EG003
Hemorrhage	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events2 affected39 at risk EG0020 events0 affected43 at risk EG003
Vascular anomaly	Cardiac disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events2 affected39 at risk EG0021 events1 affected43 at risk EG003
Constipation	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0003 events3 affected39 at risk EG0011 events1 affected39 at risk EG0022 events2 affected43 at risk EG003
Diarrhea	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0012 events2 affected39 at risk EG0022 events2 affected43 at risk EG003
Dyspepsia	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0003 events2 affected39 at risk EG0010 events0 affected39 at risk EG0022 events1 affected43 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected39 at risk EG0024 events4 affected43 at risk EG003
Periodontal abscess	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Vomiting	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events2 affected39 at risk EG0021 events1 affected43 at risk EG003
Hypothyroidism	Gastrointestinal disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0013 events3 affected39 at risk EG0020 events0 affected43 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0004 events4 affected39 at risk EG0014 events4 affected39 at risk EG0022 events2 affected43 at risk EG003
Bone disorder	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0014 events4 affected39 at risk EG0023 events3 affected43 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected39 at risk EG0022 events2 affected43 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	COSTART	Systematic Assessment	EG0003 events3 affected39 at risk EG0012 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Acute brain syndrome	Nervous system disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk EG003
Dementia	Nervous system disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0012 events2 affected39 at risk EG0021 events1 affected43 at risk EG003
Depression	Nervous system disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0011 events1 affected39 at risk EG0021 events1 affected43 at risk EG003
Neuralgia	Nervous system disorders	COSTART	Systematic Assessment	EG0003 events2 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0012 events2 affected39 at risk EG0020 events0 affected43 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected39 at risk EG0024 events4 affected43 at risk EG003
Rash	Skin and subcutaneous tissue disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0012 events2 affected39 at risk EG0021 events1 affected43 at risk EG003
Skin carcinoma	Skin and subcutaneous tissue disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0012 events2 affected39 at risk EG0021 events1 affected43 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0010 events0 affected39 at risk EG0022 events2 affected43 at risk EG003
Conjunctivitis (fellow eye)	Eye disorders	COSTART	Systematic Assessment	EG0003 events2 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Dry eyes (fellow eye)	Eye disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk EG003
Retinal disorder (fellow eye)	Eye disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events2 affected39 at risk EG0020 events0 affected43 at risk EG003
Vitreous detachment (fellow eye)	Eye disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk EG003
Diplopia (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0013 events3 affected39 at risk EG0021 events1 affected43 at risk EG003
Dry eyes (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0003 events3 affected39 at risk EG0012 events1 affected39 at risk EG0021 events1 affected43 at risk EG003
Retinal disorder (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0003 events3 affected39 at risk EG0015 events4 affected39 at risk EG0021 events1 affected43 at risk EG003
Subconjunctival hemorrhage (study eye)	Eye disorders	COSTART	Systematic Assessment	EG0002 events2 affected39 at risk EG0014 events2 affected39 at risk EG0020 events0 affected43 at risk EG003
Cystitis	Renal and urinary disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0013 events2 affected39 at risk EG0020 events0 affected43 at risk EG003
Kidney function abnormal	Renal and urinary disorders	COSTART	Systematic Assessment	EG0000 events0 affected39 at risk EG0012 events2 affected39 at risk EG0020 events0 affected43 at risk EG003
Prostatic disorder	Renal and urinary disorders	COSTART	Systematic Assessment	EG0001 events1 affected39 at risk EG0012 events2 affected39 at risk EG0023 events2 affected43 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama		United States

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

ID	Term
D000077362	Verteporfin
D010778	Photochemotherapy
D000069579	Ranibizumab
D003907	Dexamethasone

ID	Term
D011166	Porphyrins
D045725	Tetrapyrroles
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D010789	Phototherapy
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
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D013259	Steroids, Fluorinated

ID	Title	Description
BG000	1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
BG001	1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
BG002	1/2 Fluence Double Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
BG003	Ranibizumab	Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter	10	39	36	39
EG001	1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter	13	39	36	39
EG002	1/2 Fluence Double Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]	15	43	36	43
EG003	Ranibizumab	Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter	19	41	37	41

ID	Term
D020256	Choroidal Neovascularization
D008268	Macular Degeneration