Trial Outcomes & Findings for Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema (NCT NCT00464685)
NCT ID: NCT00464685
Last Updated: 2019-04-24
Results Overview
BCVA is measured in the study eye 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
253 participants
Primary outcome timeframe
Baseline, Month 12
Results posted on
2019-04-24
Participant Flow
Participant milestones
| Measure |
700 µg Dexamethasone Implant and Laser Photocoagulation
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
Sham Implant and Laser Photocoagulation
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
127
|
|
Overall Study
COMPLETED
|
103
|
94
|
|
Overall Study
NOT COMPLETED
|
23
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
700 µg Dexamethasone Implant and Laser Photocoagulation
n=126 Participants
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
Sham Implant and Laser Photocoagulation
n=127 Participants
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<45 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Customized
45 to 65 years
|
72 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
47 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: Intent to Treat: all randomized patients
BCVA is measured in the study eye 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Outcome measures
| Measure |
700 µg Dexamethasone Implant and Laser Photocoagulation
n=126 Participants
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
Sham Implant and Laser Photocoagulation
n=127 Participants
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
|---|---|---|
|
Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye
|
27.8 Percentage of Patients
|
23.6 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Intent to Treat: all randomized patients
BCVA is measured in the study eye 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Outcome measures
| Measure |
700 µg Dexamethasone Implant and Laser Photocoagulation
n=126 Participants
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
Sham Implant and Laser Photocoagulation
n=127 Participants
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
|---|---|---|
|
Change From Baseline in BCVA in the Study Eye
Baseline
|
57.6 Letters Read Correctly
Standard Deviation 9.38
|
57.8 Letters Read Correctly
Standard Deviation 9.66
|
|
Change From Baseline in BCVA in the Study Eye
Change from Baseline at Month 12
|
2.9 Letters Read Correctly
Standard Deviation 11.45
|
2.1 Letters Read Correctly
Standard Deviation 12.05
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Intent to Treat: all randomized patients
Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
700 µg Dexamethasone Implant and Laser Photocoagulation
n=126 Participants
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
Sham Implant and Laser Photocoagulation
n=127 Participants
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
|---|---|---|
|
Change From Baseline in Central Subfield Retinal Thickness in the Study Eye
Baseline
|
438.4 Microns
Standard Deviation 133.93
|
430.3 Microns
Standard Deviation 131.15
|
|
Change From Baseline in Central Subfield Retinal Thickness in the Study Eye
Change from Baseline at Month 12
|
-102.8 Microns
Standard Deviation 130.86
|
-125.3 Microns
Standard Deviation 123.38
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Intent to Treat: all randomized patients
Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.
Outcome measures
| Measure |
700 µg Dexamethasone Implant and Laser Photocoagulation
n=126 Participants
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
Sham Implant and Laser Photocoagulation
n=127 Participants
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
|---|---|---|
|
Change From Baseline in the Focal Leakage Area in the Study Eye
Baseline
|
0.6 Millimeters Squared (mm^2)
Standard Deviation 1.46
|
1.1 Millimeters Squared (mm^2)
Standard Deviation 2.64
|
|
Change From Baseline in the Focal Leakage Area in the Study Eye
Change from Baseline at Month 12
|
-0.2 Millimeters Squared (mm^2)
Standard Deviation 0.96
|
-0.7 Millimeters Squared (mm^2)
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Intent to Treat: all randomized patients
Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication.
Outcome measures
| Measure |
700 µg Dexamethasone Implant and Laser Photocoagulation
n=126 Participants
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
Sham Implant and Laser Photocoagulation
n=127 Participants
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
|---|---|---|
|
Time to Retreatment in the Study Eye
|
189 Days
Interval 189.0 to 197.0
|
196 Days
Interval 189.0 to 216.0
|
Adverse Events
700 µg Dexamethasone Implant and Laser Photocoagulation
Serious events: 23 serious events
Other events: 125 other events
Deaths: 0 deaths
Sham Implant and Laser Photocoagulation
Serious events: 27 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
700 µg Dexamethasone Implant and Laser Photocoagulation
n=125 participants at risk
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
Sham Implant and Laser Photocoagulation
n=127 participants at risk
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.6%
2/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Cardiac disorders
Coronary Artery Disease
|
1.6%
2/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic Arthropathy
|
1.6%
2/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
2/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
1.6%
2/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
1.6%
2/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Renal and urinary disorders
Renal Failure
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Vascular disorders
Aortic Stenosis
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
General disorders
Chest Pain
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Infections and infestations
Diabetic Foot Infection
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Injury, poisoning and procedural complications
Dialysis Disequilibrium Syndrome
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia Facial
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Metabolism and nutrition disorders
Hypoglycaemic Seizure
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Gastrointestinal disorders
Inguinal Hernia, Obstructive
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Infections and infestations
Osteomyelitis
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Infections and infestations
Staphylococcal Infection
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Infections and infestations
Urinary Tract Infection
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Vitreous Haemorrhage
|
0.80%
1/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.00%
0/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Infections and infestations
Gangrene
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
2.4%
3/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
1.6%
2/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
1.6%
2/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
1.6%
2/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Thyroid Gland
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Renal and urinary disorders
Bladder Neck Obstruction
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Cardiac disorders
Cardio-respiratory Arrest
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Nervous system disorders
Dementia Alzheimer's Type
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Gastrointestinal disorders
Gastrointestinal Necrosis
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Vascular disorders
Hypertension
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Vascular disorders
Hypotension
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Infections and infestations
Incision Site Infection
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Injury, poisoning and procedural complications
Skull Fracture
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
0.79%
1/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
Other adverse events
| Measure |
700 µg Dexamethasone Implant and Laser Photocoagulation
n=125 participants at risk
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
Sham Implant and Laser Photocoagulation
n=127 participants at risk
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
|
|---|---|---|
|
Eye disorders
Conjunctival Haemorrhage
|
21.6%
27/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
18.9%
24/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Vitreous Haemorrhage
|
13.6%
17/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
7.9%
10/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Visual Acuity Reduced
|
11.2%
14/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
14.2%
18/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Cataract
|
11.2%
14/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
6.3%
8/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Eye Pain
|
10.4%
13/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
8.7%
11/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Vitreous Floaters
|
10.4%
13/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
7.9%
10/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Macular Oedema
|
8.8%
11/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
7.1%
9/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Maculopathy
|
7.2%
9/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
6.3%
8/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Vitreous Detachment
|
7.2%
9/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
2.4%
3/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Retinal Exudates
|
6.4%
8/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
5.5%
7/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Diabetic Retinal Oedema
|
5.6%
7/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
8.7%
11/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Retinal Haemorrhage
|
5.6%
7/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
6.3%
8/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Eye disorders
Vision Blurred
|
5.6%
7/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
6.3%
8/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
General disorders
Oedema Peripheral
|
2.4%
3/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
6.3%
8/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Infections and infestations
Bronchitis
|
6.4%
8/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
3.9%
5/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Infections and infestations
Upper Respiratory Infection
|
4.0%
5/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
5.5%
7/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Investigations
Intraocular Pressure Increased
|
22.4%
28/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
6.3%
8/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Nervous system disorders
Headache
|
2.4%
3/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
7.1%
9/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
|
Vascular disorders
Hypertension
|
8.0%
10/125
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
6.3%
8/127
The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
|
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