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Study Assessing Double-masked Uveitis Treatment (SAKURA)

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ClinicalTrials.gov Identifier: NCT01358266
Recruitment Status : Completed
First Posted : May 23, 2011
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Uveitis; Posterior, Disorder
Interventions Drug: DE-109 44 ug
Drug: DE-109 440 ug
Drug: DE-109 880 ug
Enrollment 592
Recruitment Details  
Pre-assignment Details Subjects who entered open-label period are defined as subjects who received at least one open-label injection during the open-label treatment period (Month 6 to Month 12, exclude Amendment 2 subjects), or those who had entered the open-label retreatment period (Month 12 to Month 24) with or without any PRN injections.
Arm/Group Title DE-109 44 μg DE-109 440 μg DE-109 880 μg
Hide Arm/Group Description 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 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

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

Open-Label Treatment Period Injection on Month 6, Month 8, Month 10 Open-Label Re-Treatment Period May receive up to 6 injections PRN through Month 22 SAKURA Study 2 (Amendment #5) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4

Period Title: Double-Masked Period
Started 208 208 176
Completed 175 162 137
Not Completed 33 46 39
Period Title: Open-Label Period
Started 119 102 114
Completed 63 58 44
Not Completed 56 44 70
Arm/Group Title DE-109 44 µg DE-109 440 µg DE-109 880 µg Total
Hide Arm/Group Description Double Masked Phase Low Dose 44 µg Open Label Phase High Dose 880 µg Double Masked Phase Medium Dose 440 µg Open Label Phase High Dose 880 µg Double Masked Phase High Dose 880 µg Open Label Phase High Dose 880 µg Total of all reporting groups
Overall Number of Baseline Participants 208 208 176 592
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 208 participants 176 participants 592 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
188
  90.4%
191
  91.8%
153
  86.9%
532
  89.9%
>=65 years
20
   9.6%
17
   8.2%
23
  13.1%
60
  10.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 208 participants 176 participants 592 participants
Female
113
  54.3%
117
  56.3%
113
  64.2%
343
  57.9%
Male
95
  45.7%
91
  43.8%
63
  35.8%
249
  42.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 208 participants 176 participants 592 participants
American Indian or Alaska Native
4
   1.9%
1
   0.5%
3
   1.7%
8
   1.4%
Asian
76
  36.5%
77
  37.0%
72
  40.9%
225
  38.0%
Native Hawaiian or Other Pacific Islander
1
   0.5%
1
   0.5%
0
   0.0%
2
   0.3%
Black or African American
16
   7.7%
13
   6.3%
13
   7.4%
42
   7.1%
White
93
  44.7%
99
  47.6%
79
  44.9%
271
  45.8%
More than one race
8
   3.8%
7
   3.4%
3
   1.7%
18
   3.0%
Unknown or Not Reported
10
   4.8%
10
   4.8%
6
   3.4%
26
   4.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 208 participants 176 participants 592 participants
Colombia
4
   1.9%
4
   1.9%
5
   2.8%
13
   2.2%
Argentina
20
   9.6%
13
   6.3%
10
   5.7%
43
   7.3%
United States
70
  33.7%
71
  34.1%
45
  25.6%
186
  31.4%
Japan
4
   1.9%
8
   3.8%
6
   3.4%
18
   3.0%
United Kingdom
4
   1.9%
8
   3.8%
4
   2.3%
16
   2.7%
India
69
  33.2%
65
  31.3%
65
  36.9%
199
  33.6%
Spain
0
   0.0%
1
   0.5%
2
   1.1%
3
   0.5%
Austria
3
   1.4%
2
   1.0%
0
   0.0%
5
   0.8%
Turkey
4
   1.9%
2
   1.0%
0
   0.0%
6
   1.0%
Brazil
2
   1.0%
3
   1.4%
5
   2.8%
10
   1.7%
Poland
1
   0.5%
3
   1.4%
2
   1.1%
6
   1.0%
Italy
2
   1.0%
7
   3.4%
2
   1.1%
11
   1.9%
Israel
7
   3.4%
1
   0.5%
3
   1.7%
11
   1.9%
Chile
3
   1.4%
2
   1.0%
4
   2.3%
9
   1.5%
France
4
   1.9%
3
   1.4%
7
   4.0%
14
   2.4%
Peru
6
   2.9%
10
   4.8%
10
   5.7%
26
   4.4%
Germany
5
   2.4%
5
   2.4%
6
   3.4%
16
   2.7%
1.Primary Outcome
Title The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5
Hide Description

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

Time Frame Day1 (Baseline) and Month 5 (Day150)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DE-109 44 µg DE-109 440 µg DE-109 880 µg
Hide Arm/Group Description:
Low Dose DE-109 44 µg
Medium Dose DE-109 440 µg
High Dose DE-109 880 µg
Overall Number of Participants Analyzed 208 208 176
Measure Type: Count of Participants
Unit of Measure: Participants
28
  13.5%
44
  21.2%
27
  15.3%
2.Secondary Outcome
Title 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)
Hide Description

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)

  1. 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+
  2. Moderate blurring of the optic nerve head
  3. Marked blurring of the optic nerve head
  4. Optic Nerve head not visible
Time Frame Day1/Baseline and Day150/Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DE-109 44 µg DE-109 440 µg DE-109 880 µg
Hide Arm/Group Description:
Low Dose DE-109 44 µg
Medium Dose DE-109 440 µg
High Dose DE-109 880 µg
Overall Number of Participants Analyzed 208 208 176
Measure Type: Count of Participants
Unit of Measure: Participants
43
  20.7%
56
  26.9%
33
  18.8%
3.Secondary Outcome
Title VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)
Hide Description 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)
Time Frame Day1/Baseline and Day150/Month 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DE-109 44 µg DE-109 440 µg DE-109 880 µg
Hide Arm/Group Description:
Low Dose DE-109 44 µg
Medium Dose DE-109 440 µg
High Dose DE-109 880 µg
Overall Number of Participants Analyzed 208 208 176
Measure Type: Count of Participants
Unit of Measure: Participants
84
  40.4%
104
  50.0%
70
  39.8%
4.Other Pre-specified Outcome
Title VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)
Hide Description

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

Time Frame Day1/Baseline and Day180/Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DE-109 44 µg DE-109 440 µg DE-109 880 µg
Hide Arm/Group Description:
Low Dose DE-109 44 µg
Medium Dose DE-109 440 µg
High Dose DE-109 880 µg
Overall Number of Participants Analyzed 208 208 176
Measure Type: Count of Participants
Unit of Measure: Participants
29
  13.9%
43
  20.7%
51
  29.0%
5.Other Pre-specified Outcome
Title 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)
Hide Description

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)

  1. 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+
  2. Moderate blurring of the optic nerve head
  3. Marked blurring of the optic nerve head
  4. Optic Nerve head not visible
Time Frame Day1/Baseline and Day180/Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DE-109 44 µg DE-109 440 µg DE-109 880 µg
Hide Arm/Group Description:
Low Dose DE-109 44 µg
Medium Dose DE-109 440 µg
High Dose DE-109 880 µg
Overall Number of Participants Analyzed 208 208 176
Measure Type: Count of Participants
Unit of Measure: Participants
42
  20.2%
52
  25.0%
26
  14.8%
6.Other Pre-specified Outcome
Title VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)
Hide Description

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)

  1. 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+
  2. Moderate blurring of the optic nerve head
  3. Marked blurring of the optic nerve head
  4. Optic Nerve head not visible
Time Frame Day1/Baseline and Day180/Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DE-109 44 µg DE-109 440 µg DE-109 880 µg
Hide Arm/Group Description:
Low Dose DE-109 44 µg
Medium Dose DE-109 440 µg
High Dose DE-109 880 µg
Overall Number of Participants Analyzed 208 208 176
Measure Type: Count of Participants
Unit of Measure: Participants
81
  38.9%
90
  43.3%
66
  37.5%
Time Frame Adverse events – begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months.
Adverse Event Reporting Description

Any subject with multiple AEs of one system organ class is counted only once for that class.

Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2

1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.

 
Arm/Group Title DE-109 44 µg - Double Masked DE-109 440 µg - Double Masked DE-109 880 µg - Double Masked DE-109 880 µg - Open-Label
Hide Arm/Group Description Double Masked Phase Low Dose 44 µg Double Masked Phase Medium Dose 440 µg Double Masked Phase High Dose 880 µg Open-label Phase High Dose 880 µg
All-Cause Mortality
DE-109 44 µg - Double Masked DE-109 440 µg - Double Masked DE-109 880 µg - Double Masked DE-109 880 µg - Open-Label
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/207 (0.48%)      0/205 (0.00%)      0/178 (0.00%)      0/321 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
DE-109 44 µg - Double Masked DE-109 440 µg - Double Masked DE-109 880 µg - Double Masked DE-109 880 µg - Open-Label
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/207 (19.81%)      45/205 (21.95%)      38/178 (21.35%)      59/321 (18.38%)    
Cardiac disorders         
Coronary artery disease  1  1/207 (0.48%)  1 0/205 (0.00%)  0 0/178 (0.00%)  0 0/321 (0.00%)  0
Myocardial infarction  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Supraventricular tachycardia  1  1/207 (0.48%)  1 0/205 (0.00%)  0 0/178 (0.00%)  0 0/321 (0.00%)  0
Eye disorders         
Uveitis  1  6/207 (2.90%)  7 10/205 (4.88%)  12 13/178 (7.30%)  13 5/321 (1.56%)  7
Choroiditis  1  8/207 (3.86%)  8 4/205 (1.95%)  4 3/178 (1.69%)  4 6/321 (1.87%)  7
Cataract  1  4/207 (1.93%)  4 2/205 (0.98%)  2 3/178 (1.69%)  4 4/321 (1.25%)  6
Non-infectious endophthalmitis  1  0/207 (0.00%)  0 1/205 (0.49%)  1 7/178 (3.93%)  7 11/321 (3.43%)  11
Iridocyclitis  1  2/207 (0.97%)  2 2/205 (0.98%)  2 2/178 (1.12%)  2 0/321 (0.00%)  0
Retinal detachment  1  2/207 (0.97%)  2 2/205 (0.98%)  2 0/178 (0.00%)  0 3/321 (0.93%)  3
Visual acuity reduced  1  1/207 (0.48%)  1 3/205 (1.46%)  3 0/178 (0.00%)  0 0/321 (0.00%)  0
Vitritis  1  2/207 (0.97%)  2 2/205 (0.98%)  2 0/178 (0.00%)  0 4/321 (1.25%)  4
Cystoid macular oedema  1  2/207 (0.97%)  2 1/205 (0.49%)  2 0/178 (0.00%)  0 1/321 (0.31%)  1
Eye inflammation  1  0/207 (0.00%)  0 1/205 (0.49%)  1 2/178 (1.12%)  2 0/321 (0.00%)  0
Intermediate uveitis  1  0/207 (0.00%)  0 0/205 (0.00%)  0 3/178 (1.69%)  4 0/321 (0.00%)  0
Macular oedema  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 1/321 (0.31%)  1
Optic atrophy  1  0/207 (0.00%)  0 0/205 (0.00%)  0 1/178 (0.56%)  1 0/321 (0.00%)  0
Optic neuropathy  1  1/207 (0.48%)  1 0/205 (0.00%)  0 0/178 (0.00%)  0 1/321 (0.31%)  1
Vitreous haemorrhage  1  1/207 (0.48%)  1 1/205 (0.49%)  2 0/178 (0.00%)  0 0/321 (0.00%)  0
Anterior chamber inflammation  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Choroidal neovascularisation  1  0/207 (0.00%)  0 0/205 (0.00%)  0 0/178 (0.00%)  0 1/321 (0.31%)  1
Corneal deposits  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Corneal epithelium defect  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Corneal oedema  1  0/207 (0.00%)  0 0/205 (0.00%)  0 1/178 (0.56%)  1 0/321 (0.00%)  0
Eye haemorrhage  1  1/207 (0.48%)  1 0/205 (0.00%)  0 0/178 (0.00%)  0 0/321 (0.00%)  0
Eye pain  1  0/207 (0.00%)  0 0/205 (0.00%)  0 0/178 (0.00%)  0 1/321 (0.31%)  1
Iritis  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Ocular hypertension  1  0/207 (0.00%)  0 0/205 (0.00%)  0 1/178 (0.56%)  1 0/321 (0.00%)  0
Ocular vasculitis  1  0/207 (0.00%)  0 0/205 (0.00%)  0 0/178 (0.00%)  0 1/321 (0.31%)  1
Open angle glaucoma  1  0/207 (0.00%)  0 0/205 (0.00%)  0 0/178 (0.00%)  0 1/321 (0.31%)  1
Retinal haemorrhage  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Retinal infiltrates  1  1/207 (0.48%)  1 0/205 (0.00%)  0 0/178 (0.00%)  0 0/321 (0.00%)  0
Retinal oedema  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Retinal tear  1  1/207 (0.48%)  1 0/205 (0.00%)  0 0/178 (0.00%)  0 0/321 (0.00%)  0
Cataract subcapsular  1  0/207 (0.00%)  0 0/205 (0.00%)  0 1/178 (0.56%)  1 3/321 (0.93%)  3
Glaucoma  1  1/207 (0.48%)  2 1/205 (0.49%)  1 0/178 (0.00%)  0 2/321 (0.62%)  2
General disorders         
Medication residue  1  2/207 (0.97%)  2 2/205 (0.98%)  2 4/178 (2.25%)  5 6/321 (1.87%)  10
Device dislocation  1  0/207 (0.00%)  0 0/205 (0.00%)  0 1/178 (0.56%)  1 0/321 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis acute  1  1/207 (0.48%)  1 0/205 (0.00%)  0 0/178 (0.00%)  0 0/321 (0.00%)  0
Infections and infestations         
Endophthalmitis  1  0/207 (0.00%)  0 1/205 (0.49%)  1 1/178 (0.56%)  1 4/321 (1.25%)  4
Appendicitis  1  0/207 (0.00%)  0 0/205 (0.00%)  0 0/178 (0.00%)  0 2/321 (0.62%)  2
Eye infection toxoplasmal  1  2/207 (0.97%)  2 0/205 (0.00%)  0 0/178 (0.00%)  0 0/321 (0.00%)  0
Pneumonia  1  1/207 (0.48%)  1 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Anal abscess  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Candidiasis  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Keratitis herpetic  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Tooth infection  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Injury, poisoning and procedural complications         
Cataract traumatic  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 2/321 (0.62%)  2
Corneal abrasion  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Foot fracture  1  1/207 (0.48%)  1 0/205 (0.00%)  0 0/178 (0.00%)  0 0/321 (0.00%)  0
Hip fracture  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Lower limb fracture  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Tibia Fracture  1  1/207 (0.48%)  1 0/205 (0.00%)  0 0/178 (0.00%)  0 0/321 (0.00%)  0
Investigations         
Intraocular pressure increased  1  3/207 (1.45%)  3 3/205 (1.46%)  3 3/178 (1.69%)  3 3/321 (0.93%)  3
Fibrin  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Intraocular pressure decreased  1  0/207 (0.00%)  0 0/205 (0.00%)  0 1/178 (0.56%)  1 0/321 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Osteoarthritis  1  0/207 (0.00%)  0 0/205 (0.00%)  0 0/178 (0.00%)  0 2/321 (0.62%)  2
Intervertebral disc protrusion  1  0/207 (0.00%)  0 0/205 (0.00%)  0 0/178 (0.00%)  0 1/321 (0.31%)  1
Central nervous system lymphoma  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 1/321 (0.31%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer metastatic  1  0/207 (0.00%)  0 0/205 (0.00%)  0 0/178 (0.00%)  0 1/321 (0.31%)  1
Nervous system disorders         
Cerebrovascular accident  1 [1]  1/207 (0.48%)  1 0/205 (0.00%)  0 0/178 (0.00%)  0 0/321 (0.00%)  0
Multiple sclerosis  1  0/207 (0.00%)  0 0/205 (0.00%)  0 0/178 (0.00%)  0 1/321 (0.31%)  1
Optic Neuritis  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Transient ischaemic attack  1  0/207 (0.00%)  0 1/205 (0.49%)  1 0/178 (0.00%)  0 0/321 (0.00%)  0
Renal and urinary disorders         
Nephrolithiasis  1  1/207 (0.48%)  1 0/205 (0.00%)  0 0/178 (0.00%)  0 0/321 (0.00%)  0
Reproductive system and breast disorders         
Metrorrhagia  1  0/207 (0.00%)  0 0/205 (0.00%)  0 0/178 (0.00%)  0 1/321 (0.31%)  1
1
Term from vocabulary, MedDRA 16.0
Indicates events were collected by systematic assessment
[1]
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.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DE-109 44 µg - Double Masked DE-109 440 µg - Double Masked DE-109 880 µg - Double Masked DE-109 880 µg - Open-Label
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   165/207 (79.71%)      166/205 (80.98%)      148/178 (83.15%)      210/321 (65.42%)    
Eye disorders         
Iridocyclitis  1  31/207 (14.98%)  41 32/205 (15.61%)  46 30/178 (16.85%)  51 31/321 (9.66%)  48
Uveitis  1  19/207 (9.18%)  23 15/205 (7.32%)  18 29/178 (16.29%)  42 15/321 (4.67%)  16
Conjunctival haemorrhage  1  22/207 (10.63%)  32 19/205 (9.27%)  22 26/178 (14.61%)  33 24/321 (7.48%)  33
Eye pain  1  18/207 (8.70%)  20 22/205 (10.73%)  27 19/178 (10.67%)  22 14/321 (4.36%)  17
Intermediate uveitis  1  16/207 (7.73%)  21 15/205 (7.32%)  21 14/178 (7.87%)  20 9/321 (2.80%)  14
Cataract  1  11/207 (5.31%)  13 8/205 (3.90%)  9 13/178 (7.30%)  13 32/321 (9.97%)  33
Cystoid macular oedema  1  12/207 (5.80%)  18 15/205 (7.32%)  17 11/178 (6.18%)  12 7/321 (2.18%)  7
Choroiditis  1  11/207 (5.31%)  14 11/205 (5.37%)  15 5/178 (2.81%)  6 6/321 (1.87%)  8
Cataract subcapsular  1  3/207 (1.45%)  3 10/205 (4.88%)  10 12/178 (6.74%)  13 17/321 (5.30%)  18
Macular oedema  1  3/207 (1.45%)  3 11/205 (5.37%)  14 9/178 (5.06%)  11 8/321 (2.49%)  8
Conjunctival hyperaemia  1  11/207 (5.31%)  13 11/205 (5.37%)  12 6/178 (3.37%)  9 13/321 (4.05%)  14
Vitreous opacities  1  5/207 (2.42%)  5 5/205 (2.44%)  8 9/178 (5.06%)  13 9/321 (2.80%)  12
Dry eye  1  12/207 (5.80%)  13 4/205 (1.95%)  4 2/178 (1.12%)  2 3/321 (0.93%)  3
Investigations         
Intraocular pressure increased  1  34/207 (16.43%)  50 34/205 (16.59%)  62 43/178 (24.16%)  64 44/321 (13.71%)  62
Nervous system disorders         
Headache  1  7/207 (3.38%)  9 12/205 (5.85%)  14 4/178 (2.25%)  4 7/321 (2.18%)  8
1
Term from vocabulary, MedDRA 16.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Operations
Organization: Santen Inc.
Phone: +1-415-268-9100
EMail: clinicaltrials@santen.com
Layout table for additonal information
Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT01358266     History of Changes
Other Study ID Numbers: 32-007
First Submitted: May 19, 2011
First Posted: May 23, 2011
Results First Submitted: May 8, 2018
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019