Study Assessing Double-masked Uveitis Treatment | NCT01358266

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Ophthalmic solution low dose	Active Comparator	Drug: DE-109 44 ug
Ophthalmic solution medium dose	Active Comparator	Drug: DE-109 440 ug
Ophthalmic solution high dose	Active Comparator	Drug: DE-109 880 ug

Name	Type	Description	Arm Group Labels	Other Names
DE-109 44 ug	Drug	Low dose	Ophthalmic solution low dose	Sirolimus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5	At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation	Day1 (Baseline) and Month 5 (Day150)

Secondary Outcomes

Measure	Description	Time Frame
VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)	At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ Moderate blurring of the optic nerve head Marked blurring of the optic nerve head Optic Nerve head not visible

Other Outcomes

Measure	Description	Time Frame
VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)	At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation	Day1/Baseline and Day180/Month 6

Eligibility Module

Name	Affiliation	Role
Abu Abraham, MD	Santen Inc.	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	DE-109 44 μg	SAKURA Study 1 & Study 2 (Amendment #2) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4 Double-Masked PRN Treatment Period May receive up to 3 injections PRN from Month 6 through Month 10 SAKURA Study 1 & Study 2 (Amendments #3 and #4) Injection on Day 1, Month 2, Month 4 SAKURA Study 2 (Amendment #5) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	DE-109 44 µg	Double Masked Phase Low Dose 44 µg Open Label Phase High Dose 880 µg
BG001	DE-109 440 µg	Double Masked Phase Medium Dose 440 µg Open Label Phase High Dose 880 µg
BG002	DE-109 880 µg	Double Masked Phase High Dose 880 µg Open Label Phase High Dose 880 µg
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000113 BG001117 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0004 BG0011 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Colombia

Title	Measurements
	BG0004 BG0014 BG002

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

The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5

Vitreous Haze Scale Description VH score 0 = No inflammation

Posted

Count of Participants

Participants

Day1 (Baseline) and Month 5 (Day150)

ID	Title	Description
OG000	DE-109 44 µg	Low Dose DE-109 44 µg
OG001	DE-109 440 µg	Medium Dose DE-109 440 µg
OG002	DE-109 880 µg	High Dose DE-109 880 µg

Units	Counts
Participants	OG000208 OG001208 OG002176

Title

Denominators

Categories

Title	Measurements
	OG00028 OG00144 OG00227

Secondary

VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)

At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)

Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+
Moderate blurring of the optic nerve head
Marked blurring of the optic nerve head
Optic Nerve head not visible

Posted

Count of Participants

Participants

Day1/Baseline and Day150/Month 5

ID	Title	Description
OG000	DE-109 44 µg	Low Dose DE-109 44 µg
OG001	DE-109 440 µg	Medium Dose DE-109 440 µg
OG002	DE-109 880 µg	High Dose DE-109 880 µg

Secondary

VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)

At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0.5+=Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)

Posted

Count of Participants

Participants

Day1/Baseline and Day150/Month 5

ID	Title	Description
OG000	DE-109 44 µg	Low Dose DE-109 44 µg
OG001	DE-109 440 µg	Medium Dose DE-109 440 µg
OG002	DE-109 880 µg	High Dose DE-109 880 µg

Units	Counts
Participants

Other Pre-specified

VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)

Vitreous Haze Scale Description VH score 0 = No inflammation

Posted

Count of Participants

Participants

Day1/Baseline and Day180/Month 6

ID	Title	Description
OG000	DE-109 44 µg	Low Dose DE-109 44 µg
OG001	DE-109 440 µg	Medium Dose DE-109 440 µg
OG002	DE-109 880 µg	High Dose DE-109 880 µg

Units	Counts
Participants	OG000

Other Pre-specified

VH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale)

Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+
Moderate blurring of the optic nerve head
Marked blurring of the optic nerve head
Optic Nerve head not visible

Posted

Count of Participants

Participants

Day1/Baseline and Day180/Month 6

ID	Title	Description
OG000	DE-109 44 µg	Low Dose DE-109 44 µg
OG001	DE-109 440 µg	Medium Dose DE-109 440 µg
OG002	DE-109 880 µg	High Dose DE-109 880 µg

Other Pre-specified

VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)

Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+
Moderate blurring of the optic nerve head
Marked blurring of the optic nerve head
Optic Nerve head not visible

Posted

Count of Participants

Participants

Day1/Baseline and Day180/Month 6

ID	Title	Description
OG000	DE-109 44 µg	Low Dose DE-109 44 µg
OG001	DE-109 440 µg	Medium Dose DE-109 440 µg
OG002	DE-109 880 µg	High Dose DE-109 880 µg

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DE-109 44 µg - Double Masked	Double Masked Phase Low Dose 44 µg	1	207	41	207	165	207
EG001	DE-109 440 µg - Double Masked	Double Masked Phase Medium Dose 440 µg	0	205	45	205	166	205
EG002	DE-109 880 µg - Double Masked	Double Masked Phase High Dose 880 µg	0	178	38	178	148	178
EG003	DE-109 880 µg - Open-Label	Open-label Phase High Dose 880 µg	0	321	59	321	210	321

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Cerebrovascular accident	Nervous system disorders	MedDRA 16.0	Systematic Assessment	1 subject 44 µg dose group died • a 63-year-old male who suffered a stroke on Day 54 (11 Sep 2012) of study participation.This subject died on Study Day 55 (12 Sep 2012). This SAE was reported as severe, and not related to the study medication.	EG0001 events1 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG0030 events0 affected321 at risk
Uveitis	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0007 events6 affected207 at risk EG00112 events10 affected205 at risk EG00213 events13 affected178 at risk EG003
Choroiditis	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0008 events8 affected207 at risk EG0014 events4 affected205 at risk EG0024 events3 affected178 at risk EG003
Cataract	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0004 events4 affected207 at risk EG0012 events2 affected205 at risk EG0024 events3 affected178 at risk EG003
Non-infectious endophthalmitis	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0027 events7 affected178 at risk EG003
Iridocyclitis	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0002 events2 affected207 at risk EG0012 events2 affected205 at risk EG0022 events2 affected178 at risk EG003
Retinal detachment	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0002 events2 affected207 at risk EG0012 events2 affected205 at risk EG0020 events0 affected178 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0013 events3 affected205 at risk EG0020 events0 affected178 at risk EG003
Vitritis	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0002 events2 affected207 at risk EG0012 events2 affected205 at risk EG0020 events0 affected178 at risk EG003
Cystoid macular oedema	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0002 events2 affected207 at risk EG0012 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Eye inflammation	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0022 events2 affected178 at risk EG003
Intermediate uveitis	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0024 events3 affected178 at risk EG003
Macular oedema	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Optic atrophy	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0021 events1 affected178 at risk EG003
Optic neuropathy	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0012 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Anterior chamber inflammation	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Choroidal neovascularisation	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Corneal deposits	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Corneal epithelium defect	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Corneal oedema	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0021 events1 affected178 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Eye pain	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Iritis	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Ocular hypertension	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0021 events1 affected178 at risk EG003
Ocular vasculitis	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Open angle glaucoma	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Retinal infiltrates	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Retinal oedema	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Retinal tear	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Endophthalmitis	Infections and infestations	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0021 events1 affected178 at risk EG003
Appendicitis	Infections and infestations	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Eye infection toxoplasmal	Infections and infestations	MedDRA 16.0	Systematic Assessment		EG0002 events2 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Anal abscess	Infections and infestations	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Candidiasis	Infections and infestations	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Keratitis herpetic	Infections and infestations	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Tooth infection	Infections and infestations	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Intraocular pressure increased	Investigations	MedDRA 16.0	Systematic Assessment		EG0003 events3 affected207 at risk EG0013 events3 affected205 at risk EG0023 events3 affected178 at risk EG003
Fibrin	Investigations	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Intraocular pressure decreased	Investigations	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0021 events1 affected178 at risk EG003
Medication residue	General disorders	MedDRA 16.0	Systematic Assessment		EG0002 events2 affected207 at risk EG0012 events2 affected205 at risk EG0025 events4 affected178 at risk EG003
Device dislocation	General disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0021 events1 affected178 at risk EG003
Cataract traumatic	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Multiple sclerosis	Nervous system disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Central nervous system lymphoma	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003
Cataract subcapsular	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0010 events0 affected205 at risk EG0021 events1 affected178 at risk EG003
Glaucoma	Eye disorders	MedDRA 16.0	Systematic Assessment		EG0002 events1 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Optic Neuritis	Nervous system disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 16.0	Systematic Assessment		EG0000 events0 affected207 at risk EG0011 events1 affected205 at risk EG0020 events0 affected178 at risk EG003
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment		EG0001 events1 affected207 at risk EG0010 events0 affected205 at risk EG0020 events0 affected178 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iridocyclitis	Eye disorders	MedDRA 16.0	Systematic Assessment	EG00041 events31 affected207 at risk EG00146 events32 affected205 at risk EG00251 events30 affected178 at risk EG00348 events31 affected321 at risk
Uveitis	Eye disorders	MedDRA 16.0	Systematic Assessment	EG00023 events19 affected207 at risk EG00118 events15 affected205 at risk EG00242 events29 affected178 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 16.0	Systematic Assessment	EG00032 events22 affected207 at risk EG00122 events19 affected205 at risk EG00233 events26 affected178 at risk EG003
Eye pain	Eye disorders	MedDRA 16.0	Systematic Assessment	EG00020 events18 affected207 at risk EG00127 events22 affected205 at risk EG00222 events19 affected178 at risk EG003
Intermediate uveitis	Eye disorders	MedDRA 16.0	Systematic Assessment	EG00021 events16 affected207 at risk EG00121 events15 affected205 at risk EG00220 events14 affected178 at risk EG003
Cataract	Eye disorders	MedDRA 16.0	Systematic Assessment	EG00013 events11 affected207 at risk EG0019 events8 affected205 at risk EG00213 events13 affected178 at risk EG003
Cystoid macular oedema	Eye disorders	MedDRA 16.0	Systematic Assessment	EG00018 events12 affected207 at risk EG00117 events15 affected205 at risk EG00212 events11 affected178 at risk EG003
Choroiditis	Eye disorders	MedDRA 16.0	Systematic Assessment	EG00014 events11 affected207 at risk EG00115 events11 affected205 at risk EG0026 events5 affected178 at risk EG003
Cataract subcapsular	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected207 at risk EG00110 events10 affected205 at risk EG00213 events12 affected178 at risk EG003
Macular oedema	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected207 at risk EG00114 events11 affected205 at risk EG00211 events9 affected178 at risk EG003
Intraocular pressure increased	Investigations	MedDRA 16.0	Systematic Assessment	EG00050 events34 affected207 at risk EG00162 events34 affected205 at risk EG00264 events43 affected178 at risk EG003
Headache	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0009 events7 affected207 at risk EG00114 events12 affected205 at risk EG0024 events4 affected178 at risk EG003
Conjunctival hyperaemia	Eye disorders	MedDRA 16.0	Systematic Assessment	EG00013 events11 affected207 at risk EG00112 events11 affected205 at risk EG0029 events6 affected178 at risk EG003
Vitreous opacities	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0005 events5 affected207 at risk EG0018 events5 affected205 at risk EG00213 events9 affected178 at risk EG003
Dry eye	Eye disorders	MedDRA 16.0	Systematic Assessment	EG00013 events12 affected207 at risk EG0014 events4 affected205 at risk EG0022 events2 affected178 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona		United States

ID	Term
D014603	Uveal Diseases
D005128	Eye Diseases

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals