Trial Outcomes & Findings for Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema (NCT NCT01492400)
NCT ID: NCT01492400
Last Updated: 2019-04-17
Results Overview
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
363 participants
Primary outcome timeframe
Baseline, 12 Months
Results posted on
2019-04-17
Participant Flow
Participant milestones
| Measure |
Dexamethasone Intravitreal Implant
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
|
Ranibizumab
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
|
|---|---|---|
|
Overall Study
STARTED
|
181
|
182
|
|
Overall Study
COMPLETED
|
165
|
166
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
Reasons for withdrawal
| Measure |
Dexamethasone Intravitreal Implant
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
|
Ranibizumab
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
|
|---|---|---|
|
Overall Study
Miscellaneous Reasons
|
2
|
3
|
|
Overall Study
Personal Reasons
|
0
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Adverse Event
|
10
|
5
|
Baseline Characteristics
Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Dexamethasone Intravitreal Implant
n=181 Participants
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
|
Ranibizumab
n=182 Participants
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
|
Total
n=363 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<45 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Customized
45 to 65 years
|
102 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
74 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 MonthsPopulation: 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) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
Outcome measures
| Measure |
Dexamethasone Intravitreal Implant
n=181 Participants
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
|
Ranibizumab
n=182 Participants
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
|
|---|---|---|
|
Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline
|
60.2 Letters
Standard Deviation 9.74
|
60.4 Letters
Standard Deviation 9.34
|
|
Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Change from Baseline at 12 Months
|
4.34 Letters
Standard Deviation 7.342
|
7.60 Letters
Standard Deviation 6.735
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Intent-to-Treat: all randomized patients
OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina) in the study eye after pupil dilation. A negative change from baseline indicates an improvement (less foveal thickness) and a positive change from baseline indicates a worsening (more foveal thickness).
Outcome measures
| Measure |
Dexamethasone Intravitreal Implant
n=181 Participants
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
|
Ranibizumab
n=182 Participants
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
|
|---|---|---|
|
Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye
Baseline
|
465.1 Microns
Standard Deviation 136.09
|
471.2 Microns
Standard Deviation 139.51
|
|
Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye
Change from Baseline at Month 12 (N=163, 166)
|
-173.9 Microns
Standard Deviation 129.64
|
-163.5 Microns
Standard Deviation 161.34
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Intent-to-Treat: all randomized patients
FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. A negative change from baseline indicates a decrease in leakage (improvement) and a positive change from baseline indicates an increase in leakage (worsening).
Outcome measures
| Measure |
Dexamethasone Intravitreal Implant
n=172 Participants
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
|
Ranibizumab
n=177 Participants
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
|
|---|---|---|
|
Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)
Baseline
|
19.2 Square Millimeters (mm^2)
Standard Deviation 13.01
|
18.9 Square Millimeters (mm^2)
Standard Deviation 12.55
|
|
Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)
Change from Baseline at Month 12 (N=125, 142)
|
-16.1 Square Millimeters (mm^2)
Standard Deviation 11.64
|
-12.0 Square Millimeters (mm^2)
Standard Deviation 10.54
|
Adverse Events
Dexamethasone Intravitreal Implant
Serious events: 40 serious events
Other events: 160 other events
Deaths: 0 deaths
Ranibizumab
Serious events: 41 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexamethasone Intravitreal Implant
n=181 participants at risk
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
|
Ranibizumab
n=182 participants at risk
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
|
|---|---|---|
|
Renal and urinary disorders
Renal Failure Acute
|
2.2%
4/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.6%
3/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.2%
4/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
1.7%
3/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Coronary Artery Disease
|
1.1%
2/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.1%
2/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Sepsis
|
1.1%
2/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.1%
2/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.1%
2/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
2/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
General disorders
Chest Pain
|
1.1%
2/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.1%
2/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Investigations
Intraocular Pressure Increased
|
1.1%
2/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Nervous system disorders
Syncope
|
1.1%
2/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.1%
2/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Angina Pectoris
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.1%
2/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Cardiac Failure
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Cellulitis
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Endophthalmitis
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Pneumonia
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Wound Infection
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Abscess Limb
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Anal Abscess
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
General disorders
Asthenia
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Surgical and medical procedures
Cardiac Pacemaker Insertion
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Kidney Infection
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Surgical and medical procedures
Liposuction
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
General disorders
Local Swelling
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Metastatic
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle Cell Lymphoma
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Nervous system disorders
Meningorrhagia
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Myocardial Infarction
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Open Angle Glaucoma
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Pericardial Effusion
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Pericarditis
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.89%
1/112
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/116
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Sialoadenitis
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of the Tongue
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.55%
1/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.00%
0/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.1%
2/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.1%
2/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.1%
2/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.1%
2/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Atypical Pneumonia
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Choroiditis
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
0.00%
0/69
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.5%
1/66
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
General disorders
Generalised Oedema
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Infected Bites
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
General disorders
Oedema
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Ear and labyrinth disorders
Sudden Hearing Loss
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Cardiac disorders
Ventricular Tachyarrhythmia
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Vitreous Haemorrhage
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Investigations
Weight Decreased
|
0.00%
0/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
Other adverse events
| Measure |
Dexamethasone Intravitreal Implant
n=181 participants at risk
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
|
Ranibizumab
n=182 participants at risk
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
6/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
5.5%
10/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Conjunctival Haemorrhage
|
19.9%
36/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
13.2%
24/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Cataract
|
15.5%
28/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
4.4%
8/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Vitreous Haemorrhage
|
12.2%
22/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
3.8%
7/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Visual Acuity Reduced
|
7.7%
14/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
2.7%
5/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Cataract Subcapsular
|
7.7%
14/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
0.55%
1/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Vitreous Floaters
|
7.2%
13/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.1%
2/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Ocular Hypertension
|
6.1%
11/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.1%
2/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Eye Pain
|
5.5%
10/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
3.3%
6/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Diabetic Retinal Oedema
|
5.5%
10/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
2.7%
5/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Vitreous Detachment
|
5.5%
10/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
2.7%
5/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Punctate Keratitis
|
5.0%
9/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
1.6%
3/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Eye disorders
Macular Oedema
|
1.7%
3/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
5.5%
10/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Infections and infestations
Influenza
|
5.0%
9/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
2.2%
4/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
|
Investigations
Intraocular Pressure Increased
|
35.9%
65/181
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
6.6%
12/182
Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
|
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