Trial Outcomes & Findings for Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System (NCT NCT01080209)
NCT ID: NCT01080209
Last Updated: 2015-02-20
Results Overview
Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
215 participants
Primary outcome timeframe
Month 36
Results posted on
2015-02-20
Participant Flow
Patients enrolled in this extension study from the following parent studies: 190342-027D, 190342-028D, 190342-030D, 190342-031D, 190342-032D, and 190342-036. No treatment was administered in this study, so the treatment groups reflect the treatments received in the parent studies.
Participant milestones
| Measure |
Brimo PS DDS® 400 μg (2 Implants)
Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
|
Brimo PS DDS® 400 μg (1 Implant)
Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
|
Brimo PS DDS® 200 μg (2 Implants)
Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
|
Brimo PS DDS® 200 μg (1 Implant)
Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
|
Brimo PS DDS® 100 μg (1 Implant)
Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
|
Brimo PS DDS® 50 μg (1 Implant)
Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
|
Sham
Patients who received sham in a previous study.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
53
|
33
|
42
|
6
|
2
|
51
|
|
Overall Study
COMPLETED
|
22
|
42
|
28
|
37
|
6
|
2
|
44
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
5
|
5
|
0
|
0
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
Baseline characteristics by cohort
| Measure |
Brimo PS DDS® 400 μg (2 Implants)
n=28 Participants
Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
|
Brimo PS DDS® 400 μg (1 Implant)
n=53 Participants
Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
|
Brimo PS DDS® 200 μg (2 Implants)
n=33 Participants
Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
|
Brimo PS DDS® 200 μg (1 Implant)
n=42 Participants
Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
|
Brimo PS DDS® 100 μg (1 Implant)
n=6 Participants
Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
|
Brimo PS DDS® 50 μg (1 Implant)
n=2 Participants
Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
|
Sham
n=51 Participants
Patients who received sham in a previous study.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18 to 64 years
|
2 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
20 Participants
n=147 Participants
|
71 Participants
n=193 Participants
|
|
Age, Customized
Between 65 and 84 years
|
19 Participants
n=39 Participants
|
29 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
19 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
26 Participants
n=147 Participants
|
121 Participants
n=193 Participants
|
|
Age, Customized
≥85 years
|
7 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
5 Participants
n=147 Participants
|
23 Participants
n=193 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
21 Participants
n=147 Participants
|
106 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
29 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
22 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
30 Participants
n=147 Participants
|
109 Participants
n=193 Participants
|
PRIMARY outcome
Timeframe: Month 36Population: Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study
Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.
Outcome measures
| Measure |
Brimo PS DDS® 400 μg (2 Implants)
n=23 Participants
Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
|
Brimo PS DDS® 400 μg (1 Implant)
n=42 Participants
Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
|
Brimo PS DDS® 200 μg (2 Implants)
n=30 Participants
Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
|
Brimo PS DDS® 200 μg (1 Implant)
n=37 Participants
Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
|
Brimo PS DDS® 100 μg (1 Implant)
n=6 Participants
Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
|
Brimo PS DDS® 50 μg (1 Implant)
n=2 Participants
Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
|
Sham
n=46 Participants
Patients who received sham in a previous study.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients With No Visible Implants in the Study Eye
|
14 Patients
|
37 Patients
|
26 Patients
|
35 Patients
|
6 Patients
|
2 Patients
|
46 Patients
|
SECONDARY outcome
Timeframe: Baseline of Parent Study, Month 36Population: Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study
Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. 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). Severe vision loss is a ≥30 letter decrease in BCVA. Moderate vision loss is a ≥15 and \<30 letter decrease in BCVA. No or mild vision loss is \<15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment.
Outcome measures
| Measure |
Brimo PS DDS® 400 μg (2 Implants)
n=23 Participants
Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
|
Brimo PS DDS® 400 μg (1 Implant)
n=42 Participants
Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
|
Brimo PS DDS® 200 μg (2 Implants)
n=30 Participants
Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
|
Brimo PS DDS® 200 μg (1 Implant)
n=37 Participants
Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
|
Brimo PS DDS® 100 μg (1 Implant)
n=6 Participants
Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
|
Brimo PS DDS® 50 μg (1 Implant)
n=2 Participants
Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
|
Sham
n=46 Participants
Patients who received sham in a previous study.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients With Vision Loss in the Study Eye
No or Mild Vision Loss
|
14 Patients
|
41 Patients
|
23 Patients
|
36 Patients
|
6 Patients
|
2 Patients
|
36 Patients
|
|
Number of Patients With Vision Loss in the Study Eye
Severe Vision Loss
|
3 Patients
|
1 Patients
|
1 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
4 Patients
|
|
Number of Patients With Vision Loss in the Study Eye
Moderate Vision Loss
|
6 Patients
|
0 Patients
|
6 Patients
|
1 Patients
|
0 Patients
|
0 Patients
|
6 Patients
|
Adverse Events
Brimo PS DDS® 400 μg (2 Implants)
Serious events: 8 serious events
Other events: 13 other events
Deaths: 0 deaths
Brimo PS DDS® 400 μg (1 Implant)
Serious events: 11 serious events
Other events: 30 other events
Deaths: 0 deaths
Brimo PS DDS® 200 μg (2 Implants)
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Brimo PS DDS® 200 μg (1 Implant)
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
Brimo PS DDS® 100 μg (1 Implant)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Brimo PS DDS® 50 μg (1 Implant)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham
Serious events: 16 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brimo PS DDS® 400 μg (2 Implants)
n=28 participants at risk
Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
|
Brimo PS DDS® 400 μg (1 Implant)
n=53 participants at risk
Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
|
Brimo PS DDS® 200 μg (2 Implants)
n=33 participants at risk
Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
|
Brimo PS DDS® 200 μg (1 Implant)
n=42 participants at risk
Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
|
Brimo PS DDS® 100 μg (1 Implant)
n=6 participants at risk
Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
|
Brimo PS DDS® 50 μg (1 Implant)
n=2 participants at risk
Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
|
Sham
n=51 participants at risk
Patients who received sham in a previous study.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
3.6%
1/28
|
1.9%
1/53
|
0.00%
0/33
|
2.4%
1/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Cardiac disorders
Angina Pectoris
|
3.6%
1/28
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
5.3%
1/19
|
0.00%
0/24
|
0.00%
0/17
|
5.0%
1/20
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/21
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
3.6%
1/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Eye disorders
Age-Related Macular Degeneration
|
3.6%
1/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Nervous system disorders
Cerebrovascular Accident
|
3.6%
1/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Reproductive system and breast disorders
Cystocele
|
5.3%
1/19
|
0.00%
0/24
|
0.00%
0/17
|
0.00%
0/20
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/21
|
|
General disorders
Death
|
3.6%
1/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Vascular disorders
Deep Vein Thrombosis
|
3.6%
1/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Gastrointestinal disorders
Enterocele
|
3.6%
1/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
3.6%
1/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
3.6%
1/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.6%
1/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Reproductive system and breast disorders
Rectocele
|
5.3%
1/19
|
0.00%
0/24
|
0.00%
0/17
|
0.00%
0/20
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/21
|
|
General disorders
Sudden Cardiac Death
|
3.6%
1/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
3.6%
1/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Visual Acuity Reduced
|
3.6%
1/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/28
|
1.9%
1/53
|
0.00%
0/33
|
2.4%
1/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.00%
0/28
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Cardiac disorders
Cardio-respiratory Arrest
|
0.00%
0/28
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/28
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/28
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/28
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Cardiac disorders
Palpitations
|
0.00%
0/28
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/9
|
3.4%
1/29
|
0.00%
0/16
|
0.00%
0/22
|
0.00%
0/3
|
—
0/0
|
0.00%
0/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.00%
0/28
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Retinal Vein Occlusion
|
0.00%
0/28
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/28
|
0.00%
0/53
|
6.1%
2/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/28
|
0.00%
0/53
|
3.0%
1/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Eye disorders
Anterior Chamber Inflammation
|
0.00%
0/28
|
0.00%
0/53
|
3.0%
1/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/28
|
0.00%
0/53
|
3.0%
1/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Infections and infestations
Gangrene
|
0.00%
0/28
|
0.00%
0/53
|
3.0%
1/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/28
|
0.00%
0/53
|
3.0%
1/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.00%
0/28
|
0.00%
0/53
|
3.0%
1/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Open Angle Glaucoma
|
0.00%
0/28
|
0.00%
0/53
|
3.0%
1/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.00%
0/28
|
0.00%
0/53
|
3.0%
1/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Infections and infestations
Pneumonia
|
0.00%
0/28
|
0.00%
0/53
|
3.0%
1/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/28
|
0.00%
0/53
|
3.0%
1/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
2.4%
1/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular Carcinoma
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
2.4%
1/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
2.4%
1/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
2.4%
1/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
2.4%
1/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/9
|
0.00%
0/29
|
0.00%
0/16
|
4.5%
1/22
|
0.00%
0/3
|
—
0/0
|
0.00%
0/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
2.4%
1/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Recurrent
|
0.00%
0/9
|
0.00%
0/29
|
0.00%
0/16
|
0.00%
0/22
|
33.3%
1/3
|
—
0/0
|
0.00%
0/30
|
|
Nervous system disorders
Syncope
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
3.9%
2/51
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Vascular disorders
Hypertension
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Vascular disorders
Intermittent Claudication
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Injury, poisoning and procedural complications
Jaw Fracture
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Gastrointestinal disorders
Oesophagitis Ulcerative
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Injury, poisoning and procedural complications
Pubis Fracture
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
2.0%
1/51
|
|
Eye disorders
Optic Atrophy
|
0.00%
0/28
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/28
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/28
|
1.9%
1/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
Other adverse events
| Measure |
Brimo PS DDS® 400 μg (2 Implants)
n=28 participants at risk
Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
|
Brimo PS DDS® 400 μg (1 Implant)
n=53 participants at risk
Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
|
Brimo PS DDS® 200 μg (2 Implants)
n=33 participants at risk
Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
|
Brimo PS DDS® 200 μg (1 Implant)
n=42 participants at risk
Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
|
Brimo PS DDS® 100 μg (1 Implant)
n=6 participants at risk
Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
|
Brimo PS DDS® 50 μg (1 Implant)
n=2 participants at risk
Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
|
Sham
n=51 participants at risk
Patients who received sham in a previous study.
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Infections and infestations
Otitis Media Chronic
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
50.0%
1/2
|
0.00%
0/51
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Cataract Subscapular
|
0.00%
0/28
|
7.5%
4/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Cataract
|
10.7%
3/28
|
11.3%
6/53
|
0.00%
0/33
|
14.3%
6/42
|
0.00%
0/6
|
0.00%
0/2
|
11.8%
6/51
|
|
Eye disorders
Visual Acuity Reduced
|
10.7%
3/28
|
5.7%
3/53
|
9.1%
3/33
|
11.9%
5/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Age-Related Macular Degeneration
|
7.1%
2/28
|
0.00%
0/53
|
9.1%
3/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Nervous system disorders
Neuropathy Peripheral
|
7.1%
2/28
|
0.00%
0/53
|
9.1%
3/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Vitreous Detachment
|
7.1%
2/28
|
0.00%
0/53
|
6.1%
2/33
|
9.5%
4/42
|
0.00%
0/6
|
0.00%
0/2
|
7.8%
4/51
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
2/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
5.9%
3/51
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
2/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
2/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Cardiac disorders
Coronary Artery Disease
|
7.1%
2/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Cardiac disorders
Bradycardia
|
7.1%
2/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Nervous system disorders
Dementia
|
7.1%
2/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/28
|
9.4%
5/53
|
9.1%
3/33
|
7.1%
3/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/28
|
5.7%
3/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
100.0%
2/2
|
0.00%
0/51
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Retinal Haemorrhage
|
0.00%
0/28
|
0.00%
0/53
|
6.1%
2/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
5.9%
3/51
|
|
Eye disorders
Posterior Capsule Opacification
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
7.8%
4/51
|
|
Investigations
Intraocular Pressure Increased
|
0.00%
0/28
|
11.3%
6/53
|
0.00%
0/33
|
9.5%
4/42
|
0.00%
0/6
|
0.00%
0/2
|
7.8%
4/51
|
|
Eye disorders
Dry Eye
|
0.00%
0/28
|
9.4%
5/53
|
6.1%
2/33
|
9.5%
4/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Macular Fibrosis
|
0.00%
0/28
|
7.5%
4/53
|
0.00%
0/33
|
7.1%
3/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Vascular disorders
Hypertension
|
0.00%
0/28
|
5.7%
3/53
|
9.1%
3/33
|
9.5%
4/42
|
0.00%
0/6
|
0.00%
0/2
|
7.8%
4/51
|
|
Eye disorders
Optic Disc Haemorrhage
|
0.00%
0/28
|
5.7%
3/53
|
6.1%
2/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Infections and infestations
Pneumonia
|
0.00%
0/28
|
5.7%
3/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Glaucoma
|
0.00%
0/28
|
5.7%
3/53
|
0.00%
0/33
|
9.5%
4/42
|
0.00%
0/6
|
0.00%
0/2
|
9.8%
5/51
|
|
Eye disorders
Macular Degeneration
|
0.00%
0/28
|
5.7%
3/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Blepharitis
|
0.00%
0/28
|
0.00%
0/53
|
6.1%
2/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Nervous system disorders
Headache
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/9
|
0.00%
0/29
|
0.00%
0/16
|
13.6%
3/22
|
0.00%
0/3
|
—
0/0
|
0.00%
0/30
|
|
Infections and infestations
Influenza
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
5.9%
3/51
|
|
Eye disorders
Glare
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
0.00%
0/6
|
50.0%
1/2
|
0.00%
0/51
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/28
|
0.00%
0/53
|
6.1%
2/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/28
|
0.00%
0/53
|
6.1%
2/33
|
0.00%
0/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Eye disorders
Cataract Cortical
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
7.1%
3/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Psychiatric disorders
Depression
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
7.1%
3/42
|
0.00%
0/6
|
0.00%
0/2
|
0.00%
0/51
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/28
|
0.00%
0/53
|
0.00%
0/33
|
0.00%
0/42
|
16.7%
1/6
|
0.00%
0/2
|
0.00%
0/51
|
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