Trial Outcomes & Findings for A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion (NCT NCT00168324)
NCT ID: NCT00168324
Last Updated: 2019-04-23
Results Overview
The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
599 participants
Primary outcome timeframe
Up to 180 Days
Results posted on
2019-04-23
Participant Flow
Patients were randomly assigned during the double-blind period of the study to treatment with 700 µg dexamethasone, 350 µg dexamethasone, or sham injection on Day 0. Patients who qualified to continue in the open-label period of the study received 700 µg dexamethasone on Day 180.
Participant milestones
| Measure |
700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
|
350 µg Dexamethasone Followed by 700 µg Dexamethasone
350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
|
Sham Injection Followed by 700 µg Dexamethasone
Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
|
|---|---|---|---|
|
Double-Blind Period
STARTED
|
201
|
196
|
202
|
|
Double-Blind Period
COMPLETED
|
189
|
189
|
189
|
|
Double-Blind Period
NOT COMPLETED
|
12
|
7
|
13
|
|
Open-Label Period
STARTED
|
164
|
155
|
158
|
|
Open-Label Period
COMPLETED
|
160
|
147
|
152
|
|
Open-Label Period
NOT COMPLETED
|
4
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
700 µg Dexamethasone
n=201 Participants
700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
|
350 µg Dexamethasone Followed by 700 µg Dexamethasone
n=196 Participants
350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
|
Sham Injection Followed by 700 µg Dexamethasone
n=202 Participants
Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
|
Total
n=599 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<45 years
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Age, Customized
45-65 years
|
83 participants
n=5 Participants
|
84 participants
n=7 Participants
|
90 participants
n=5 Participants
|
257 participants
n=4 Participants
|
|
Age, Customized
>65 years
|
109 participants
n=5 Participants
|
105 participants
n=7 Participants
|
103 participants
n=5 Participants
|
317 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
327 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 180 DaysPopulation: Intent-to-Treat: all randomized patients
The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.
Outcome measures
| Measure |
700 µg Dexamethasone
n=201 Participants
700 µg dexamethasone intravitreal implant administered on Day 0.
|
350 µg Dexamethasone
n=196 Participants
350 µg Dexamethasone intravitreal implant administered on Day 0.
|
Sham Injection
n=202 Participants
Sham injection on Day 0.
|
|---|---|---|---|
|
Cumulative Response Rate of 15 or More Letter Improvement
Day 30
|
0.101 Kaplan-Meier Estimate
|
0.092 Kaplan-Meier Estimate
|
0.045 Kaplan-Meier Estimate
|
|
Cumulative Response Rate of 15 or More Letter Improvement
Day 60
|
0.258 Kaplan-Meier Estimate
|
0.204 Kaplan-Meier Estimate
|
0.100 Kaplan-Meier Estimate
|
|
Cumulative Response Rate of 15 or More Letter Improvement
Day 90
|
0.359 Kaplan-Meier Estimate
|
0.292 Kaplan-Meier Estimate
|
0.165 Kaplan-Meier Estimate
|
|
Cumulative Response Rate of 15 or More Letter Improvement
Day 180
|
0.397 Kaplan-Meier Estimate
|
0.349 Kaplan-Meier Estimate
|
0.225 Kaplan-Meier Estimate
|
SECONDARY outcome
Timeframe: Day 90, Day 180Population: Intent-to-Treat: all randomized patients
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye at each visit are presented.
Outcome measures
| Measure |
700 µg Dexamethasone
n=201 Participants
700 µg dexamethasone intravitreal implant administered on Day 0.
|
350 µg Dexamethasone
n=196 Participants
350 µg Dexamethasone intravitreal implant administered on Day 0.
|
Sham Injection
n=202 Participants
Sham injection on Day 0.
|
|---|---|---|---|
|
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
Day 90
|
45 Number of Participants
|
41 Number of Participants
|
25 Number of Participants
|
|
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
Day 180
|
39 Number of Participants
|
32 Number of Participants
|
37 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 90, Day 180Population: Intent-to-Treat: all randomized patients
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Outcome measures
| Measure |
700 µg Dexamethasone
n=201 Participants
700 µg dexamethasone intravitreal implant administered on Day 0.
|
350 µg Dexamethasone
n=196 Participants
350 µg Dexamethasone intravitreal implant administered on Day 0.
|
Sham Injection
n=202 Participants
Sham injection on Day 0.
|
|---|---|---|---|
|
Change From Baseline in Retinal Thickness in the Study Eye
Baseline
|
548.9 Microns (µm)
Standard Deviation 185.45
|
541.6 Microns (µm)
Standard Deviation 183.68
|
534.4 Microns (µm)
Standard Deviation 187.38
|
|
Change From Baseline in Retinal Thickness in the Study Eye
Change from Baseline at Day 90
|
-199.3 Microns (µm)
Standard Deviation 194.54
|
-144.1 Microns (µm)
Standard Deviation 166.59
|
-78.2 Microns (µm)
Standard Deviation 150.05
|
|
Change From Baseline in Retinal Thickness in the Study Eye
Change from Baseline at Day 180
|
-105.0 Microns (µm)
Standard Deviation 197.83
|
-91.4 Microns (µm)
Standard Deviation 198.16
|
-110.3 Microns (µm)
Standard Deviation 175.59
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Intent-to-Treat: all randomized patients
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening.
Outcome measures
| Measure |
700 µg Dexamethasone
n=201 Participants
700 µg dexamethasone intravitreal implant administered on Day 0.
|
350 µg Dexamethasone
n=196 Participants
350 µg Dexamethasone intravitreal implant administered on Day 0.
|
Sham Injection
n=202 Participants
Sham injection on Day 0.
|
|---|---|---|---|
|
Percentage of Patients With a Change From Baseline in BCVA by Category
≥15 Letters Improvement
|
22.4 Percentage of Patients
|
20.9 Percentage of Patients
|
12.4 Percentage of Patients
|
|
Percentage of Patients With a Change From Baseline in BCVA by Category
≥5 and <15 Letters Improvement
|
39.8 Percentage of Patients
|
42.3 Percentage of Patients
|
34.2 Percentage of Patients
|
|
Percentage of Patients With a Change From Baseline in BCVA by Category
No Change (Between -5 to +5 Letters)
|
27.4 Percentage of Patients
|
23.5 Percentage of Patients
|
34.7 Percentage of Patients
|
|
Percentage of Patients With a Change From Baseline in BCVA by Category
≥5 and <15 Letters Worsening
|
7.0 Percentage of Patients
|
9.2 Percentage of Patients
|
13.4 Percentage of Patients
|
|
Percentage of Patients With a Change From Baseline in BCVA by Category
≥15 Letters Worsening
|
3.5 Percentage of Patients
|
4.1 Percentage of Patients
|
5.4 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Day 180Population: Intent-to-Treat: all randomized patients
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening.
Outcome measures
| Measure |
700 µg Dexamethasone
n=201 Participants
700 µg dexamethasone intravitreal implant administered on Day 0.
|
350 µg Dexamethasone
n=196 Participants
350 µg Dexamethasone intravitreal implant administered on Day 0.
|
Sham Injection
n=202 Participants
Sham injection on Day 0.
|
|---|---|---|---|
|
Percentage of Patients With a Change From Baseline in BCVA by Category
≥15 Letters Improvement
|
19.4 Percentage of Patients
|
16.3 Percentage of Patients
|
18.3 Percentage of Patients
|
|
Percentage of Patients With a Change From Baseline in BCVA by Category
≥5 and <15 Letters Improvement
|
34.8 Percentage of Patients
|
37.8 Percentage of Patients
|
27.7 Percentage of Patients
|
|
Percentage of Patients With a Change From Baseline in BCVA by Category
No Change (Between -5 to +5 Letters)
|
29.4 Percentage of Patients
|
25.5 Percentage of Patients
|
30.2 Percentage of Patients
|
|
Percentage of Patients With a Change From Baseline in BCVA by Category
≥5 and <15 Letters Worsening
|
10.9 Percentage of Patients
|
10.7 Percentage of Patients
|
14.9 Percentage of Patients
|
|
Percentage of Patients With a Change From Baseline in BCVA by Category
≥15 Letters Worsening
|
5.5 Percentage of Patients
|
9.7 Percentage of Patients
|
8.9 Percentage of Patients
|
Adverse Events
700 µg Dexamethasone
Serious events: 12 serious events
Other events: 119 other events
Deaths: 0 deaths
350 µg Dexamethasone
Serious events: 28 serious events
Other events: 107 other events
Deaths: 0 deaths
Sham Injection
Serious events: 14 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
700 µg Dexamethasone
n=196 participants at risk
700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
|
350 µg Dexamethasone
n=197 participants at risk
350 µg Dexamethasone intravitreal implant administered on Day 0.
|
Sham Injection
n=202 participants at risk
Sham injection on Day 0.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
1.0%
2/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.51%
1/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
2.0%
4/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Investigations
Intraocular pressure increased
|
0.51%
1/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
1.5%
3/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.51%
1/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.50%
1/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.51%
1/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.51%
1/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Psychiatric disorders
Mental status changes
|
0.51%
1/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.51%
1/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.51%
1/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.51%
1/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.51%
1/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
1.0%
2/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.99%
2/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Eye disorders
Glaucoma
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.50%
1/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Eye disorders
Blindness
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
General disorders
Drowning
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Vascular disorders
Hypotension
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.51%
1/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Investigations
Blood pressure increased
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.50%
1/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.50%
1/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
General disorders
Chest pain
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.50%
1/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.50%
1/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.50%
1/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.50%
1/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.50%
1/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.50%
1/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.50%
1/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.00%
0/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
0.50%
1/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
Other adverse events
| Measure |
700 µg Dexamethasone
n=196 participants at risk
700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
|
350 µg Dexamethasone
n=197 participants at risk
350 µg Dexamethasone intravitreal implant administered on Day 0.
|
Sham Injection
n=202 participants at risk
Sham injection on Day 0.
|
|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
19.9%
39/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
17.8%
35/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
12.9%
26/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Eye disorders
Eye pain
|
6.6%
13/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
4.1%
8/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
3.5%
7/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Eye disorders
Maculopathy
|
5.6%
11/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
3.6%
7/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
8.4%
17/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Eye disorders
Conjunctival hyperaemia
|
5.1%
10/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
5.6%
11/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
3.5%
7/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
|
Investigations
Intraocular pressure increased
|
23.5%
46/196 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
23.4%
46/197 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
3.0%
6/202 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER