A Safety and Efficacy Study Comparing the Combination Tre... | NCT00242580

Name	Class
QLT Inc.	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Verteporfin and Triamcinolone 1 mg	Experimental	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Drug: Verteporfin photodynamic therapy Drug: Triamcinolone acetonide
Verteporfin and Triamcinolone 4 mg	Experimental	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	Drug: Verteporfin photodynamic therapy Drug: Triamcinolone acetonide
Verteporfin and Pegaptanib	Active Comparator	Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Verteporfin photodynamic therapy	Drug	After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.

Measure	Description	Time Frame
Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.	Baseline to Month 12

Measure	Description	Time Frame
Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigational Site		Austin	Texas	78793	United States

Label	URL
Novartis patient recruitment website: Clinical trial information for patients and caregivers	View source

ID	Title	Description
FG000	Verteporfin + 1 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.

Arm/Group Information

ID	Title	Description
BG000	Verteporfin + 1 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
BG001	Verteporfin + 4 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
BG002	Verteporfin + Pegaptanib	Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00032 BG00141 BG00238 BG003111

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

Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.

Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.

Posted

Number

Percentage of Participants

Baseline to Month 12

ID	Title	Description
OG000	Verteporfin + 1 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
OG001	Verteporfin + 4 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
OG002	Verteporfin + Pegaptanib	Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.

Units	Counts
Participants	OG00032 OG00141 OG00238

Title

Denominators

Categories

Title	Measurements
	OG00059.4 OG00163.4 OG00271.1

Secondary

Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline.

Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.

Posted

Number

Percentage of Participants

Baseline to Month 12

ID	Title	Description
OG000	Verteporfin + 1 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
OG001	Verteporfin + 4 mg Triamcinolone

Secondary

Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 10 or more letters of visual acuity at 12 months as compared with baseline.

Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.

Posted

Number

Percentage of Participants

Baseline to Month 12

ID	Title	Description
OG000	Verteporfin + 1 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
OG001	Verteporfin + 4 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.

Secondary

Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at 12 months as compared with baseline.

Efficacy variable analyses were performed on the intent-to-treat (ITT) data set. The ITT set includes data from all randomized patients. Missing data were imputed using last observation carried forward.

Posted

Number

Percentage of Participants

Baseline to Month 12

ID	Title	Description
OG000	Verteporfin + 1 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
OG001	Verteporfin + 4 mg Triamcinolone

Secondary

Number of Participants Requiring Verteporfin Treatment Throughout the Study

Participants received study drug at the Baseline visit and subsequent retreatment at 3 month intervals if leakage was detected on the fluorescein angiogram. The cumulative distribution of the number of treatments is shown per arm.

Observed data.

Posted

Number

Participants

Baseline to Month 12

ID	Title	Description
OG000	Verteporfin + 1 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
OG001	Verteporfin + 4 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.

Secondary

Mean Change From Baseline in Total Area of Lesion at 12 Months

Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis.

Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.

Posted

Mean

Standard Deviation

mm^2

Baseline to Month 12

ID	Title	Description
OG000	Verteporfin + 1 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
OG001	Verteporfin + 4 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Verteporfin + 1 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	11	32	32	32
EG001	Verteporfin + 4 mg Triamcinolone	Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.	9	41	38	41
EG002	Verteporfin + Pegaptanib	Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.	10	38	30	38

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ACCIDENTAL INJURY	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0011 affected41 at risk EG0023 affected38 at risk
ANAPHYLACTOID REACTION	Immune system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0020 affected38 at risk
CHEST PAIN	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
CYST	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
HERNIA	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0020 affected38 at risk
INFECTION	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0020 affected38 at risk
NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0020 affected38 at risk
AORTIC STENOSIS	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0020 affected38 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
ARTERIAL ANOMALY	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
ARTERIAL THROMBOSIS	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0020 affected38 at risk
ARTERIOSCLEROSIS	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0020 affected38 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0020 affected38 at risk
CONGESTIVE HEART FAILURE	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0020 affected38 at risk
CORONARY ARTERY DISORDER	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0012 affected41 at risk EG0021 affected38 at risk
DEEP THROMBOPHLEBITIS	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
HEART BLOCK	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0020 affected38 at risk
MYOCARDIAL INFARCT	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0021 affected38 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0020 affected38 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0020 affected38 at risk
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0022 affected38 at risk
GASTROINTESTINAL HEMORRHAGE	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0020 affected38 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
PEPTIC ULCER HEMORRHAGE	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0020 affected38 at risk
HYPOKALEMIA	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0020 affected38 at risk
OSTEOPOROSIS	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
CEREBRAL INFARCT	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0012 affected41 at risk EG0020 affected38 at risk
CEREBRAL ISCHEMIA	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0020 affected38 at risk
ENCEPHALOPATHY	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
LUNG EDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0020 affected38 at risk
PNEUMONIA	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0012 affected41 at risk EG0022 affected38 at risk
ACUTE KIDNEY FAILURE	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ACCIDENTAL INJURY	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0012 affected41 at risk EG0025 affected38 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0013 affected41 at risk EG0020 affected38 at risk
HEADACHE	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0004 affected32 at risk EG0011 affected41 at risk EG0023 affected38 at risk
INFECTION	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0005 affected32 at risk EG0012 affected41 at risk EG0020 affected38 at risk
INJECTION SITE EXTRAVASATION	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0010 affected41 at risk EG0023 affected38 at risk
PAIN	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0005 affected32 at risk EG0014 affected41 at risk EG0023 affected38 at risk
CORONARY ARTERY DISORDER	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0013 affected41 at risk EG0021 affected38 at risk
HYPERTENSION	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0007 affected32 at risk EG0017 affected41 at risk EG0022 affected38 at risk
DIARRHEA	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0012 affected41 at risk EG0022 affected38 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0012 affected41 at risk EG0021 affected38 at risk
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0014 affected41 at risk EG0023 affected38 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0004 affected32 at risk EG0010 affected41 at risk EG0023 affected38 at risk
RECTAL DISORDER	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0013 affected41 at risk EG0020 affected38 at risk
ANEMIA	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0013 affected41 at risk EG0021 affected38 at risk
HYPERLIPEMIA	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0010 affected41 at risk EG0022 affected38 at risk
PERIPHERAL EDEMA	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0010 affected41 at risk EG0022 affected38 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0014 affected41 at risk EG0020 affected38 at risk
ANXIETY	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0022 affected38 at risk
DEMENTIA	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0012 affected41 at risk EG0022 affected38 at risk
INSOMNIA	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0023 affected38 at risk
BRONCHITIS	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0010 affected41 at risk EG0021 affected38 at risk
COUGH INCREASED	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0013 affected41 at risk EG0022 affected38 at risk
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0022 affected38 at risk
PNEUMONIA	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0022 affected38 at risk
RHINITIS	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected32 at risk EG0016 affected41 at risk EG0022 affected38 at risk
SINUSITIS	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0012 affected41 at risk EG0021 affected38 at risk
CONTACT DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0022 affected38 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0022 affected38 at risk
SKIN DISORDER	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0010 affected41 at risk EG0020 affected38 at risk
AMD PROGRESSION (Fellow eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0005 affected32 at risk EG0016 affected41 at risk EG0027 affected38 at risk
BLEPHARITIS (Fellow eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0022 affected38 at risk
CATARACT (Fellow eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected32 at risk EG0014 affected41 at risk EG0022 affected38 at risk
CONJUNCTIVITIS (Fellow eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0010 affected41 at risk EG0022 affected38 at risk
DRY EYES (Fellow eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0011 affected41 at risk EG0024 affected38 at risk
EYE DISORDER (Fellow eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0022 affected38 at risk
EYE ITCHING (Fellow eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0010 affected41 at risk EG0020 affected38 at risk
RETINAL DISORDER (Fellow eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0013 affected41 at risk EG0022 affected38 at risk
RETINAL HEMORRHAGE (Fellow eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0022 affected38 at risk
SUBRETINAL HEMORRHAGE (Fellow eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0010 affected41 at risk EG0020 affected38 at risk
TINNITUS	Ear and labyrinth disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0010 affected41 at risk EG0022 affected38 at risk
VISION DECREASED (Fellow eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected32 at risk EG0011 affected41 at risk EG0022 affected38 at risk
ACUTE ELEVATED IOP (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0017 affected41 at risk EG0020 affected38 at risk
AMD PROGRESSION (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0006 affected32 at risk EG0018 affected41 at risk EG0023 affected38 at risk
BLEPHARITIS (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0010 affected41 at risk EG0022 affected38 at risk
CATARACT (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0008 affected32 at risk EG00110 affected41 at risk EG0022 affected38 at risk
CONJUNCTIVITIS (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected32 at risk EG0010 affected41 at risk EG0022 affected38 at risk
DRY EYES (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0012 affected41 at risk EG0024 affected38 at risk
EYE HEMORRHAGE (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0005 affected32 at risk EG0017 affected41 at risk EG0027 affected38 at risk
EYE ITCHING (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0010 affected41 at risk EG0020 affected38 at risk
EYE PAIN (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0015 affected41 at risk EG0022 affected38 at risk
RETINAL DISORDER (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0013 affected41 at risk EG0021 affected38 at risk
RETINAL EDEMA (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected32 at risk EG0014 affected41 at risk EG0020 affected38 at risk
RETINAL HEMORRHAGE (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0012 affected41 at risk EG0020 affected38 at risk
RETINAL PIGMENTATION (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0011 affected41 at risk EG0022 affected38 at risk
SUBRETINAL HEMORRHAGE (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected32 at risk EG0011 affected41 at risk EG0022 affected38 at risk
VISION ABNORMAL (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0004 affected32 at risk EG0015 affected41 at risk EG0023 affected38 at risk
VISION DECREASED (Study eye)	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected32 at risk EG0013 affected41 at risk EG0023 affected38 at risk
URINARY TRACT INFECTION	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected32 at risk EG0015 affected41 at risk EG0025 affected38 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
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
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D013259	Steroids, Fluorinated

ID	Term
D000077362	Verteporfin
C495058	pegaptanib
D014222	Triamcinolone Acetonide
D014221	Triamcinolone