The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study
Sponsor
The Emmes Company, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00105027
Collaborator
National Eye Institute (NEI) (NIH), Allergan (Industry)
682
1
6
52
13.1
Study Details
Study Description
Brief Summary
The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Macular edema is a major cause of vision loss in patients with CRVO and BRVO. Both CRVO and BRVO are common retinal problems and are caused by a blockage in one of the large retinal veins (central retinal vein occlusion - CRVO) or smaller retinal veins (branch retinal vein occlusion - BRVO). Currently, there is no effective treatment for macular edema associated with CRVO and standard care treatment is observation. Grid laser photocoagulation may be effective for some patients for macular edema associated with BRVO, but many patients derive limited benefit from this treatment. Therefore, the development of new treatment modalities for macular edema caused by these two conditions is an important research goal.
Over the last several years, many patients with macular edema from CRVO and BRVO have been treated with an injection of a type of steroid called triamcinolone directly into the eye. This type of injection is called an intravitreal injection. The triamcinolone preparation commonly injected into the eye is Kenalog and is FDA-approved only for use in muscles and joints. The SCORE Study will use a formulation of triamcinolone made specifically for the eye.
The SCORE Study is a multicenter, randomized, Phase III trial to compare the effectiveness and safety of standard care versus triamcinolone injection(s) for the treatment of macular edema associated with CRVO and BRVO. In each of the two disease areas, 630 participants will be randomized (similar to a flip of a coin) in a 1:1:1 ratio to one of three groups: standard care, intravitreal triamcinolone 4 mg, or intravitreal triamcinolone 1 mg. After randomization, participants will be examined every 4 months through 3 years to collect ophthalmic information, including visual acuity, intraocular pressure, optical coherence tomography, and fundus photography . Fluorescein angiography will be performed at 4, 12 and 24 months. Repeat intravitreal injections of triamcinolone and repeat laser treatment will be provided as clinically indicated based on protocol-specific guidelines.
The primary outcome is improvement by 15 or more letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit. Secondary outcomes include changes from baseline in best-corrected ETDRS visual acuity score, changes in retinal thickness as assessed by stereoscopic color fundus photography and optical coherence tomography, and adverse ocular outcomes.
Study Design
Study Type:
Interventional
Actual Enrollment
:
682 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study: Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide With Standard Care to Treat Macular Edema
Study Start Date
:
Oct 1, 2004
Actual Primary Completion Date
:
Feb 1, 2009
Actual Study Completion Date
:
Feb 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CRVO Observation
|
Other: Standard Care
CRVO: observation; BRVO: standard care
|
| Active Comparator: CRVO 1 mg dose triamcinolone acetonide
|
Drug: intravitreal triamcinolone injection
1 mg dose
|
| Active Comparator: CRVO 4 mg dose triamcinolone acetonide
|
Drug: intravitreal triamcinolone injection
4 mg
|
| Active Comparator: BRVO standard care
|
Other: Standard Care
CRVO: observation; BRVO: standard care
|
| Active Comparator: BRVO 1 mg dose triamcinolone acetonide
|
Drug: intravitreal triamcinolone injection
1 mg dose
|
| Active Comparator: BRVO 4 mg dose triamcinolone acetonide
|
Drug: intravitreal triamcinolone injection
4 mg
|
Outcome Measures
Primary Outcome Measures
- The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit [Change from baseline to 12 months]
Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart.
Secondary Outcome Measures
- Changes From Baseline in Best-corrected ETDRS Visual Acuity Score [12 months]
- Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography [12 months]
- Adverse Ocular Outcomes [12 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants with macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
-
Individuals, 18 years of age or older, willing to provide consent may be eligible for the SCORE Study.
Exclusion Criteria: refer to SCORE Study website at https://web.emmes.com/study/score/ for listing.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Wisconsin | Madison | Wisconsin | United States | 53711 |
Sponsors and Collaborators
- The Emmes Company, LLC
- National Eye Institute (NEI)
- Allergan
Investigators
- Study Chair: Michael S. Ip, M.D., University of Wisconsin, Madison
Study Documents (Full-Text)
More Information
Publications
- Bhavsar AR, Ip MS, Glassman AR; DRCRnet and the SCORE Study Groups. The risk of endophthalmitis following intravitreal triamcinolone injection in the DRCRnet and SCORE clinical trials. Am J Ophthalmol. 2007 Sep;144(3):454-6.
- Blodi BA, Domalpally A, Scott IU, Ip MS, Oden NL, Elledge J, Warren K, Altaweel MM, Kim JE, Van Veldhuisen PC; SCORE Study Research Group. Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study system for evaluation of stereoscopic color fundus photographs and fluorescein angiograms: SCORE Study Report 9. Arch Ophthalmol. 2010 Sep;128(9):1140-5. doi: 10.1001/archophthalmol.2010.193.
- Chan CK, Ip MS, Vanveldhuisen PC, Oden NL, Scott IU, Tolentino MJ, Blodi BA; SCORE Study Investigator Group. SCORE Study report #11: incidences of neovascular events in eyes with retinal vein occlusion. Ophthalmology. 2011 Jul;118(7):1364-72. doi: 10.1016/j.ophtha.2010.11.020. Epub 2011 Mar 26.
- Domalpally A, Blodi BA, Scott IU, Ip MS, Oden NL, Lauer AK, VanVeldhuisen PC; SCORE Study Investigator Group. The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study system for evaluation of optical coherence tomograms: SCORE study report 4. Arch Ophthalmol. 2009 Nov;127(11):1461-7. doi: 10.1001/archophthalmol.2009.277.
- Domalpally A, Peng Q, Danis R, Blodi B, Scott IU, Ip M; SCORE Study Research Group. Association of outer retinal layer morphology with visual acuity in patients with retinal vein occlusion: SCORE Study Report 13. Eye (Lond). 2012 Jul;26(7):919-24. doi: 10.1038/eye.2012.59. Epub 2012 Apr 27.
- Ip MS, Oden NL, Scott IU, VanVeldhuisen PC, Blodi BA, Figueroa M, Antoszyk A, Elman M; SCORE Study Investigator Group. SCORE Study report 3: study design and baseline characteristics. Ophthalmology. 2009 Sep;116(9):1770-1777.e1. doi: 10.1016/j.ophtha.2009.03.022. Epub 2009 Jul 19.
- Oden N, Vanveldhuisen PC, Scott IU, Ip MS; the SCORE Study Investigator Group. SCORE Study Report 8: Closed Tests for All Pair-Wise Comparisons of Means. Drug Inf J. 2010 Jul 1;44(4):405-420.
- Scott IU, Blodi BA, Ip MS, Vanveldhuisen PC, Oden NL, Chan CK, Gonzalez V; SCORE Study Investigator Group. SCORE Study Report 2: Interobserver agreement between investigator and reading center classification of retinal vein occlusion type. Ophthalmology. 2009 Apr;116(4):756-61. doi: 10.1016/j.ophtha.2008.11.015.
- Scott IU, Oden NL, VanVeldhuisen PC, Ip MS, Blodi BA, Antoszyk AN; SCORE Study Investigator Group. SCORE Study Report 7: incidence of intravitreal silicone oil droplets associated with staked-on vs luer cone syringe design. Am J Ophthalmol. 2009 Nov;148(5):725-732.e7. doi: 10.1016/j.ajo.2009.06.004. Epub 2009 Aug 11.
- Scott IU, VanVeldhuisen PC, Oden NL, Ip MS, Blodi BA, Hartnett ME, Cohen G; Standard Care versus COrticosteroid for REtinal Vein Occlusion Study Investigator Group. Baseline predictors of visual acuity and retinal thickness outcomes in patients with retinal vein occlusion: Standard Care Versus COrticosteroid for REtinal Vein Occlusion Study report 10. Ophthalmology. 2011 Feb;118(2):345-52. doi: 10.1016/j.ophtha.2010.06.034.
- Scott IU, VanVeldhuisen PC, Oden NL, Ip MS, Blodi BA, Jumper JM, Figueroa M; SCORE Study Investigator Group. SCORE Study report 1: baseline associations between central retinal thickness and visual acuity in patients with retinal vein occlusion. Ophthalmology. 2009 Mar;116(3):504-12. doi: 10.1016/j.ophtha.2008.10.017. Epub 2009 Jan 22.
Responsible Party:
The Emmes Company, LLC
ClinicalTrials.gov Identifier:
NCT00105027
Other Study ID Numbers:
- NEI-99
- 5U10EY014351-05
- 5U10EY014404
- 5U10EY014352
First Posted:
Mar 4, 2005
Last Update Posted:
Jul 2, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by The Emmes Company, LLC
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Between November 8, 2004, and February 29, 2008, 271 patients with central retinal vein occlusion (CRVO) were enrolled from 66 clinical sites and 411 patients with branch retinal vein occlusion (BRVO) were enrolled from 75 clinical sites across the United States. Participant flow data are reported for the primary outcome measure (12 months). |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CRVO Observation | CRVO 1 mg Dose Triamcinolone Acetonide | CRVO 4 mg Dose Triamcinolone Acetonide | BRVO Standard Care | BRVO 1 mg Dose Triamcinolone Acetonide | BRVO 4 mg Dose Triamcinolone Acetonide |
|---|---|---|---|---|---|---|
| Arm/Group Description | Standard care consists of observation of the macular edema. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). |
| Period Title: Overall Study | ||||||
| STARTED | 88 | 92 | 91 | 137 | 136 | 138 |
| COMPLETED | 73 | 83 | 82 | 121 | 121 | 125 |
| NOT COMPLETED | 15 | 9 | 9 | 16 | 15 | 13 |
Baseline Characteristics
| Arm/Group Title | CRVO Observation | CRVO 1 mg Dose Triamcinolone Acetonide | CRVO 4 mg Dose Triamcinolone Acetonide | BRVO Standard Care | BRVO 1 mg Dose Triamcinolone Acetonide | BRVO 4 mg Dose Triamcinolone Acetonide | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Standard care consists of observation of the macular edema. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Total of all reporting groups |
| Overall Participants | 88 | 92 | 91 | 137 | 136 | 138 | 682 |
| Age (Count of Participants) | |||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
25
28.4%
|
35
38%
|
34
37.4%
|
62
45.3%
|
54
39.7%
|
55
39.9%
|
265
38.9%
|
| >=65 years |
63
71.6%
|
57
62%
|
57
62.6%
|
75
54.7%
|
82
60.3%
|
83
60.1%
|
417
61.1%
|
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
69.2
(12.8)
|
67.4
(12.4)
|
67.5
(12.0)
|
66.9
(11.5)
|
67.2
(11.5)
|
68.1
(10.6)
|
67.7
(11.2)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
40
45.5%
|
43
46.7%
|
40
44%
|
71
51.8%
|
68
50%
|
63
45.7%
|
325
47.7%
|
| Male |
48
54.5%
|
49
53.3%
|
51
56%
|
66
48.2%
|
68
50%
|
75
54.3%
|
357
52.3%
|
| Region of Enrollment (participants) [Number] | |||||||
| United States |
88
100%
|
92
100%
|
91
100%
|
137
100%
|
136
100%
|
138
100%
|
682
100%
|
Outcome Measures
| Title | The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit |
|---|---|
| Description | Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart. |
| Time Frame | Change from baseline to 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CRVO Observation | CRVO 1 mg Dose Triamcinolone Acetonide | CRVO 4 mg Dose Triamcinolone Acetonide | BRVO Standard Care | BRVO 1 mg Dose Triamcinolone Acetonide | BRVO 4 mg Dose Triamcinolone Acetonide |
|---|---|---|---|---|---|---|
| Arm/Group Description | Standard care consists of observation of the macular edema. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). |
| Measure Participants | 88 | 92 | 91 | 137 | 136 | 138 |
| Number [Participants] |
5
5.7%
|
22
23.9%
|
21
23.1%
|
35
25.5%
|
31
22.8%
|
34
24.6%
|
| Title | Changes From Baseline in Best-corrected ETDRS Visual Acuity Score |
|---|---|
| Description | |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who attended month 12 visit |
| Arm/Group Title | CRVO Observation | CRVO 1 mg Dose Triamcinolone Acetonide | CRVO 4 mg Dose Triamcinolone Acetonide | BRVO Standard Care | BRVO 1 mg Dose Triamcinolone Acetonide | BRVO 4 mg Dose Triamcinolone Acetonide |
|---|---|---|---|---|---|---|
| Arm/Group Description | Standard care consists of observation of the macular edema. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). |
| Measure Participants | 73 | 83 | 82 | 121 | 121 | 125 |
| Mean (95% Confidence Interval) [letters read] |
-12.1
|
-1.2
|
-1.2
|
4.2
|
5.7
|
4.0
|
| Title | Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography |
|---|---|
| Description | |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who attended month 12 visit |
| Arm/Group Title | CRVO Observation | CRVO 1 mg Dose Triamcinolone Acetonide | CRVO 4 mg Dose Triamcinolone Acetonide | BRVO Standard Care | BRVO 1 mg Dose Triamcinolone Acetonide | BRVO 4 mg Dose Triamcinolone Acetonide |
|---|---|---|---|---|---|---|
| Arm/Group Description | Standard care consists of observation of the macular edema. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). |
| Measure Participants | 68 | 72 | 78 | 120 | 113 | 112 |
| Median (Inter-Quartile Range) [um] |
-277
|
-196
|
-261
|
-224
|
-149
|
-170
|
| Title | Adverse Ocular Outcomes |
|---|---|
| Description | |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants experiencing an adverse event |
| Arm/Group Title | CRVO Observation | CRVO 1 mg Dose Triamcinolone Acetonide | CRVO 4 mg Dose Triamcinolone Acetonide | BRVO Standard Care | BRVO 1 mg Dose Triamcinolone Acetonide | BRVO 4 mg Dose Triamcinolone Acetonide |
|---|---|---|---|---|---|---|
| Arm/Group Description | Standard care consists of observation of the macular edema. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). |
| Measure Participants | 88 | 92 | 91 | 137 | 136 | 138 |
| Initiation of IOP-lowering medications |
7
|
18
|
32
|
3
|
11
|
57
|
| IOP > 35 mm HG |
1
|
5
|
8
|
1
|
2
|
14
|
| IOP > 10 mm HG above baseline |
2
|
15
|
24
|
1
|
12
|
50
|
| Laser peripheral iridotomy |
0
|
0
|
1
|
0
|
0
|
1
|
| Trabeculectomy |
0
|
0
|
0
|
0
|
0
|
0
|
| Tube shunt |
0
|
2
|
0
|
0
|
0
|
0
|
| Cataract: lens opacity onset or progression |
12
|
20
|
25
|
15
|
27
|
38
|
| Cataract surgery |
0
|
0
|
4
|
3
|
0
|
4
|
| Infectious endophthalmitis |
0
|
0
|
0
|
0
|
0
|
1
|
| Noninfectious endophthalmitis |
0
|
0
|
0
|
0
|
0
|
0
|
| Retinal detachment |
0
|
0
|
0
|
1
|
1
|
0
|
| Iris neovascularization |
2
|
9
|
4
|
1
|
1
|
2
|
| Retinal neovascularization |
4
|
2
|
2
|
5
|
1
|
3
|
| Vitreous hemorrhage |
4
|
4
|
0
|
2
|
1
|
3
|
| YAG capsulotomy |
1
|
0
|
0
|
1
|
0
|
1
|
| Sector or panretinal photocagulation |
5
|
9
|
3
|
5
|
1
|
4
|
| Pars plana vitrectomy |
1
|
2
|
0
|
1
|
0
|
1
|
Adverse Events
| Time Frame | Three years | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits. | |||||||||||
| Arm/Group Title | CRVO Observation | CRVO 1 mg Dose Triamcinolone Acetonide | CRVO 4 mg Dose Triamcinolone Acetonide | BRVO Standard Care | BRVO 1 mg Dose Triamcinolone Acetonide | BRVO 4 mg Dose Triamcinolone Acetonide | ||||||
| Arm/Group Description | Standard care consists of observation of the macular edema. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment. | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | ||||||
All Cause Mortality |
||||||||||||
| CRVO Observation | CRVO 1 mg Dose Triamcinolone Acetonide | CRVO 4 mg Dose Triamcinolone Acetonide | BRVO Standard Care | BRVO 1 mg Dose Triamcinolone Acetonide | BRVO 4 mg Dose Triamcinolone Acetonide | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/88 (0%) | 1/92 (1.1%) | 2/91 (2.2%) | 3/137 (2.2%) | 2/136 (1.5%) | 2/138 (1.4%) | ||||||
Serious Adverse Events |
||||||||||||
| CRVO Observation | CRVO 1 mg Dose Triamcinolone Acetonide | CRVO 4 mg Dose Triamcinolone Acetonide | BRVO Standard Care | BRVO 1 mg Dose Triamcinolone Acetonide | BRVO 4 mg Dose Triamcinolone Acetonide | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 32/88 (36.4%) | 37/92 (40.2%) | 53/91 (58.2%) | 47/137 (34.3%) | 49/136 (36%) | 79/138 (57.2%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 0/88 (0%) | 0 | 1/92 (1.1%) | 2 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Cardiac disorders | ||||||||||||
| Angina pectoris | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Angina unstable | 3/88 (3.4%) | 3 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Atrial fibrillation | 0/88 (0%) | 0 | 2/92 (2.2%) | 2 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Atrioventricular block | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Cardiac arrest | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Cardiac disorder | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Cardiac failure | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Cardiac failure congestive | 1/88 (1.1%) | 1 | 2/92 (2.2%) | 2 | 2/91 (2.2%) | 2 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 2/138 (1.4%) | 2 |
| Cardiomyopathy | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Cardiovascular disorder | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Coronary artery disease | 2/88 (2.3%) | 2 | 1/92 (1.1%) | 2 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 1/136 (0.7%) | 1 | 2/138 (1.4%) | 2 |
| Myocardial infarction | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 2/91 (2.2%) | 2 | 0/137 (0%) | 0 | 2/136 (1.5%) | 2 | 2/138 (1.4%) | 2 |
| Palpitations | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Sick sinus syndrome | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Sinus bradycardia | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Eye disorders | ||||||||||||
| Angle closure glaucoma | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 1/138 (0.7%) | 1 |
| Anisometropia | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Anterior chamber disorder | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Cataract | 5/88 (5.7%) | 5 | 9/92 (9.8%) | 10 | 28/91 (30.8%) | 30 | 12/137 (8.8%) | 16 | 16/136 (11.8%) | 18 | 40/138 (29%) | 46 |
| Cataract cortical | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 2/138 (1.4%) | 2 |
| Cataract nuclear | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 1/138 (0.7%) | 1 |
| Cataract subcapsular | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 1/137 (0.7%) | 1 | 1/136 (0.7%) | 1 | 12/138 (8.7%) | 12 |
| Choroidal neovascularisation | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Endophthalmitis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Eye pain | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Glaucoma | 1/88 (1.1%) | 1 | 5/92 (5.4%) | 5 | 3/91 (3.3%) | 3 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 2/138 (1.4%) | 3 |
| Iris neovascularisation | 1/88 (1.1%) | 1 | 2/92 (2.2%) | 2 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Macular degeneration | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Macular hole | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Maculopathy | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Ocular hypertension | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Optic nerve cupping | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Posterior capsule opacification | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 2/137 (1.5%) | 2 | 2/136 (1.5%) | 2 | 0/138 (0%) | 0 |
| Retinal detachment | 0/88 (0%) | 0 | 2/92 (2.2%) | 2 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 2/136 (1.5%) | 2 | 1/138 (0.7%) | 1 |
| Retinal neovascularisation | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Retinal tear | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Retinal vein occlusion | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Retinopathy proliferative | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Uveitis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Vitreous haemorrhage | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 1/138 (0.7%) | 1 |
| Vitreous prolapse | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Abdominal hernia | 1/88 (1.1%) | 1 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Ascites | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Colitis ischaemic | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Constipation | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Diarrhoea | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Diverticular hernia | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Dysphagia | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Gastritis | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Gastrointestinal haemorrhage | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 2/91 (2.2%) | 2 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Gastrointestinal oedema | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Haematochezia | 1/88 (1.1%) | 1 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Haemorrhoids | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Inguinal hernia | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Inguinal hernia, obstructive | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Intestinal haemorrhage | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Intestinal obstruction | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Large intestine perforation | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Pancreatitis | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Peritonitis | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Rectal haemorrhage | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Small intestinal obstruction | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| General disorders | ||||||||||||
| Asthenia | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Chest discomfort | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Chest pain | 1/88 (1.1%) | 1 | 1/92 (1.1%) | 2 | 0/91 (0%) | 0 | 3/137 (2.2%) | 3 | 1/136 (0.7%) | 1 | 2/138 (1.4%) | 2 |
| Death | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Non-cardiac chest pain | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Polyp | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Pyrexia | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||
| Cholecystitis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Cholecystitis acute | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Cholelithiasis | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 2/138 (1.4%) | 2 |
| Gallbladder pain | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Hepatic failure | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Hepatomegaly | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Immune system disorders | ||||||||||||
| Drug hypersensitivity | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Infections and infestations | ||||||||||||
| Abdominal wall abscess | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Arthritis bacterial | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Bronchitis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Cellulitis | 2/88 (2.3%) | 2 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 2/136 (1.5%) | 3 | 1/138 (0.7%) | 1 |
| Chronic sinusitis | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Clostridial infection | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Cystitis | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Diverticulitis | 0/88 (0%) | 0 | 2/92 (2.2%) | 2 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 1/138 (0.7%) | 1 |
| Gastroenteritis | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Gastroenteritis viral | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Infection | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Lung infection | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Pneumonia | 2/88 (2.3%) | 2 | 2/92 (2.2%) | 2 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 4/136 (2.9%) | 4 | 2/138 (1.4%) | 2 |
| Sepsis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Sinusitis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Staphylococcal infection | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Urinary tract infection | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 2 | 0/138 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||
| Ankle fracture | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Arthropod bite | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Cartilage injury | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 1/138 (0.7%) | 1 |
| Concussion | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Conjunctival filtering bleb leak | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Corneal abrasion | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Drug toxicity | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Facial bones fracture | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Fall | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Femur fracture | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Foot fracture | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 1/138 (0.7%) | 1 |
| Gastroenteritis radiation | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Head injury | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Heat stroke | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Hip fracture | 1/88 (1.1%) | 2 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Injury | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Joint injury | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Lower limb fracture | 1/88 (1.1%) | 1 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Rib fracture | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Skeletal injury | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Spinal fracture | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Vascular procedure complication | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Investigations | ||||||||||||
| Blood glucose increased | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Blood pressure increased | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Heart rate decreased | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Heart rate increased | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Heart rate irregular | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Intraocular pressure increased | 3/88 (3.4%) | 4 | 2/92 (2.2%) | 3 | 3/91 (3.3%) | 3 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 4/138 (2.9%) | 4 |
| Metabolism and nutrition disorders | ||||||||||||
| Dehydration | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Electrolyte imbalance | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Hyponatraemia | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 2/91 (2.2%) | 2 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Arthritis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Arthropathy | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Back pain | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Cervical spinal stenosis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Intervertebral disc protrusion | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 2 | 0/138 (0%) | 0 |
| Joint effusion | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Muscle twitching | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Musculoskeletal pain | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 1/138 (0.7%) | 2 |
| Osteoarthritis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 2/137 (1.5%) | 2 | 1/136 (0.7%) | 2 | 0/138 (0%) | 0 |
| Rotator cuff syndrome | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Spinal column stenosis | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Benign colonic neoplasm | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Bladder cancer | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 3/137 (2.2%) | 3 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Bone cancer metastatic | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Breast cancer | 1/88 (1.1%) | 1 | 1/92 (1.1%) | 1 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Colon cancer | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Endometrial cancer | 0/88 (0%) | 0 | 1/92 (1.1%) | 2 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Hepatic neoplasm malignant | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Lung neoplasm malignant | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 3/91 (3.3%) | 3 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Malignant melanoma | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Mantle cell lymphoma | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Multiple myeloma | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Neuroendocrine tumour | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Pancreatic carcinoma | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 1/138 (0.7%) | 1 |
| Prostate cancer | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Renal cancer metastatic | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Spinal cord neoplasm | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| T-cell lymphoma | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Throat cancer | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Uterine leiomyoma | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 2/137 (1.5%) | 2 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Brain stem infarction | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Carotid artery disease | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Carotid artery stenosis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Central nervous system lesion | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Cerebellar haemorrhage | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Cerebral haemorrhage | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Cerebrovascular accident | 2/88 (2.3%) | 2 | 0/92 (0%) | 0 | 4/91 (4.4%) | 5 | 3/137 (2.2%) | 3 | 1/136 (0.7%) | 1 | 3/138 (2.2%) | 3 |
| Dizziness | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 3 | 0/138 (0%) | 0 |
| Haemorrhage intracranial | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Lumbar radiculopathy | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Paraesthesia | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Presyncope | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Syncope | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 3/91 (3.3%) | 3 | 1/137 (0.7%) | 1 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Transient ischaemic attack | 2/88 (2.3%) | 2 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 2/137 (1.5%) | 2 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Psychiatric disorders | ||||||||||||
| Alcoholism | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Anxiety | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||
| Automatic bladder | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Bladder disorder | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Haematuria | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Incontinence | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Nephrolithiasis | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Renal failure | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Renal failure acute | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Renal failure chronic | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Renal impairment | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Urinary retention | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||
| Benign prostatic hyperplasia | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 2/136 (1.5%) | 2 | 0/138 (0%) | 0 |
| Cystocele | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Prostatic mass | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Uterine haemorrhage | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Chronic obstructive pulmonary disease | 0/88 (0%) | 0 | 1/92 (1.1%) | 2 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Cough | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Dyspnoea | 1/88 (1.1%) | 1 | 1/92 (1.1%) | 1 | 2/91 (2.2%) | 4 | 2/137 (1.5%) | 2 | 0/136 (0%) | 0 | 2/138 (1.4%) | 2 |
| Hypoxia | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Pleural effusion | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Pulmonary embolism | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Pulmonary fibrosis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Respiratory failure | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Surgical and medical procedures | ||||||||||||
| Cardiac pacemaker insertion | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Coronary arterial stent insertion | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Finger amputation | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
| Hip arthroplasty | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Knee arthroplasty | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Nephrectomy | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Vascular graft | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 1/136 (0.7%) | 1 | 1/138 (0.7%) | 1 |
| Vascular disorders | ||||||||||||
| Aortic aneurysm | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/137 (0%) | 0 | 2/136 (1.5%) | 2 | 0/138 (0%) | 0 |
| Aortic dissection | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Aortic stenosis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Arteriosclerosis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 1/138 (0.7%) | 1 |
| Deep vein thrombosis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 2/138 (1.4%) | 2 |
| Hypotension | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Peripheral vascular disorder | 1/88 (1.1%) | 1 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/137 (0%) | 0 | 0/136 (0%) | 0 | 0/138 (0%) | 0 |
| Thrombosis | 0/88 (0%) | 0 | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/137 (0.7%) | 1 | 1/136 (0.7%) | 1 | 0/138 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| CRVO Observation | CRVO 1 mg Dose Triamcinolone Acetonide | CRVO 4 mg Dose Triamcinolone Acetonide | BRVO Standard Care | BRVO 1 mg Dose Triamcinolone Acetonide | BRVO 4 mg Dose Triamcinolone Acetonide | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 76/88 (86.4%) | 87/92 (94.6%) | 89/91 (97.8%) | 118/137 (86.1%) | 132/136 (97.1%) | 133/138 (96.4%) | ||||||
| Eye disorders | ||||||||||||
| Blepharitis | 0/88 (0%) | 0 | 3/92 (3.3%) | 5 | 8/91 (8.8%) | 19 | 4/137 (2.9%) | 8 | 9/136 (6.6%) | 16 | 6/138 (4.3%) | 11 |
| Cataract | 10/88 (11.4%) | 14 | 9/92 (9.8%) | 12 | 14/91 (15.4%) | 16 | 15/137 (10.9%) | 27 | 19/136 (14%) | 28 | 21/138 (15.2%) | 25 |
| Cataract subcapsular | 3/88 (3.4%) | 3 | 8/92 (8.7%) | 8 | 12/91 (13.2%) | 12 | 2/137 (1.5%) | 3 | 13/136 (9.6%) | 14 | 16/138 (11.6%) | 18 |
| Conjunctival haemorrhage | 3/88 (3.4%) | 7 | 34/92 (37%) | 54 | 30/91 (33%) | 57 | 9/137 (6.6%) | 9 | 54/136 (39.7%) | 88 | 54/138 (39.1%) | 82 |
| Dry eye | 3/88 (3.4%) | 6 | 3/92 (3.3%) | 5 | 2/91 (2.2%) | 3 | 5/137 (3.6%) | 12 | 7/136 (5.1%) | 13 | 6/138 (4.3%) | 10 |
| Eye irritation | 2/88 (2.3%) | 2 | 11/92 (12%) | 12 | 9/91 (9.9%) | 14 | 6/137 (4.4%) | 8 | 17/136 (12.5%) | 28 | 8/138 (5.8%) | 9 |
| Eye pain | 6/88 (6.8%) | 6 | 15/92 (16.3%) | 25 | 18/91 (19.8%) | 36 | 9/137 (6.6%) | 13 | 23/136 (16.9%) | 34 | 18/138 (13%) | 26 |
| Eyelid ptosis | 0/88 (0%) | 0 | 1/92 (1.1%) | 1 | 6/91 (6.6%) | 8 | 5/137 (3.6%) | 7 | 0/136 (0%) | 0 | 10/138 (7.2%) | 11 |
| Foreign body sensation in eyes | 4/88 (4.5%) | 5 | 8/92 (8.7%) | 8 | 3/91 (3.3%) | 3 | 1/137 (0.7%) | 1 | 13/136 (9.6%) | 13 | 12/138 (8.7%) | 14 |
| Glaucoma | 1/88 (1.1%) | 1 | 1/92 (1.1%) | 1 | 5/91 (5.5%) | 5 | 2/137 (1.5%) | 3 | 1/136 (0.7%) | 2 | 6/138 (4.3%) | 7 |
| Iris neovascularisation | 2/88 (2.3%) | 2 | 6/92 (6.5%) | 7 | 3/91 (3.3%) | 3 | 0/137 (0%) | 0 | 2/136 (1.5%) | 2 | 1/138 (0.7%) | 2 |
| Lacrimation increased | 1/88 (1.1%) | 1 | 5/92 (5.4%) | 6 | 4/91 (4.4%) | 7 | 5/137 (3.6%) | 8 | 5/136 (3.7%) | 7 | 6/138 (4.3%) | 7 |
| Macular oedema | 2/88 (2.3%) | 2 | 6/92 (6.5%) | 6 | 2/91 (2.2%) | 2 | 3/137 (2.2%) | 3 | 3/136 (2.2%) | 3 | 1/138 (0.7%) | 1 |
| Maculopathy | 5/88 (5.7%) | 5 | 9/92 (9.8%) | 10 | 10/91 (11%) | 10 | 9/137 (6.6%) | 10 | 12/136 (8.8%) | 14 | 9/138 (6.5%) | 10 |
| Myodesopsia | 8/88 (9.1%) | 9 | 32/92 (34.8%) | 44 | 34/91 (37.4%) | 52 | 17/137 (12.4%) | 23 | 59/136 (43.4%) | 81 | 45/138 (32.6%) | 64 |
| Photopsia | 3/88 (3.4%) | 3 | 7/92 (7.6%) | 8 | 4/91 (4.4%) | 4 | 5/137 (3.6%) | 6 | 10/136 (7.4%) | 11 | 5/138 (3.6%) | 6 |
| Retinal haemorrhage | 1/88 (1.1%) | 1 | 6/92 (6.5%) | 6 | 1/91 (1.1%) | 2 | 4/137 (2.9%) | 5 | 1/136 (0.7%) | 1 | 2/138 (1.4%) | 2 |
| Retinal neovascularisation | 6/88 (6.8%) | 6 | 4/92 (4.3%) | 4 | 6/91 (6.6%) | 6 | 6/137 (4.4%) | 8 | 1/136 (0.7%) | 1 | 5/138 (3.6%) | 5 |
| Retinal vascular disorder | 0/88 (0%) | 0 | 6/92 (6.5%) | 6 | 1/91 (1.1%) | 2 | 2/137 (1.5%) | 2 | 4/136 (2.9%) | 4 | 3/138 (2.2%) | 3 |
| Retinal vein occlusion | 4/88 (4.5%) | 4 | 4/92 (4.3%) | 4 | 3/91 (3.3%) | 3 | 6/137 (4.4%) | 6 | 3/136 (2.2%) | 3 | 8/138 (5.8%) | 10 |
| Vision blurred | 5/88 (5.7%) | 6 | 6/92 (6.5%) | 11 | 9/91 (9.9%) | 13 | 14/137 (10.2%) | 19 | 15/136 (11%) | 19 | 17/138 (12.3%) | 22 |
| Visual acuity reduced | 10/88 (11.4%) | 10 | 12/92 (13%) | 14 | 10/91 (11%) | 15 | 6/137 (4.4%) | 11 | 11/136 (8.1%) | 12 | 13/138 (9.4%) | 15 |
| Visual impairment | 5/88 (5.7%) | 5 | 5/92 (5.4%) | 5 | 3/91 (3.3%) | 4 | 11/137 (8%) | 14 | 9/136 (6.6%) | 10 | 7/138 (5.1%) | 10 |
| Vitreous detachment | 8/88 (9.1%) | 9 | 16/92 (17.4%) | 19 | 10/91 (11%) | 12 | 15/137 (10.9%) | 20 | 21/136 (15.4%) | 25 | 12/138 (8.7%) | 14 |
| Vitreous haemorrhage | 7/88 (8%) | 7 | 8/92 (8.7%) | 8 | 2/91 (2.2%) | 2 | 2/137 (1.5%) | 2 | 5/136 (3.7%) | 5 | 5/138 (3.6%) | 5 |
| Infections and infestations | ||||||||||||
| Bronchitis | 1/88 (1.1%) | 1 | 3/92 (3.3%) | 4 | 5/91 (5.5%) | 6 | 5/137 (3.6%) | 6 | 3/136 (2.2%) | 3 | 4/138 (2.9%) | 4 |
| Nasopharyngitis | 0/88 (0%) | 0 | 2/92 (2.2%) | 3 | 6/91 (6.6%) | 7 | 8/137 (5.8%) | 8 | 5/136 (3.7%) | 6 | 9/138 (6.5%) | 10 |
| Injury, poisoning and procedural complications | ||||||||||||
| Foreign body in eye | 5/88 (5.7%) | 5 | 31/92 (33.7%) | 31 | 22/91 (24.2%) | 22 | 4/137 (2.9%) | 4 | 67/136 (49.3%) | 67 | 31/138 (22.5%) | 31 |
| Investigations | ||||||||||||
| Intraocular pressure increased | 8/88 (9.1%) | 10 | 20/92 (21.7%) | 24 | 42/91 (46.2%) | 55 | 7/137 (5.1%) | 9 | 19/136 (14%) | 24 | 64/138 (46.4%) | 88 |
| Metabolism and nutrition disorders | ||||||||||||
| Hypercholesterolaemia | 4/88 (4.5%) | 4 | 1/92 (1.1%) | 1 | 5/91 (5.5%) | 5 | 4/137 (2.9%) | 4 | 6/136 (4.4%) | 6 | 6/138 (4.3%) | 7 |
| Nervous system disorders | ||||||||||||
| Headache | 6/88 (6.8%) | 6 | 5/92 (5.4%) | 5 | 7/91 (7.7%) | 8 | 4/137 (2.9%) | 4 | 4/136 (2.9%) | 6 | 5/138 (3.6%) | 9 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Cough | 0/88 (0%) | 0 | 5/92 (5.4%) | 5 | 1/91 (1.1%) | 1 | 1/137 (0.7%) | 1 | 6/136 (4.4%) | 6 | 4/138 (2.9%) | 4 |
| Vascular disorders | ||||||||||||
| Hypertension | 2/88 (2.3%) | 2 | 2/92 (2.2%) | 2 | 4/91 (4.4%) | 4 | 6/137 (4.4%) | 6 | 12/136 (8.8%) | 12 | 12/138 (8.7%) | 12 |
Limitations/Caveats
[Not Specified]
More Information
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
| Name/Title | Paul C. VanVeldhuisen, Ph.D. |
|---|---|
| Organization | The EMMES Corporation |
| Phone | 301-251-1161 |
| score@emmes.com |
Responsible Party:
The Emmes Company, LLC
ClinicalTrials.gov Identifier:
NCT00105027
Other Study ID Numbers:
- NEI-99
- 5U10EY014351-05
- 5U10EY014404
- 5U10EY014352
First Posted:
Mar 4, 2005
Last Update Posted:
Jul 2, 2018
Last Verified:
May 1, 2018