Trial Outcomes & Findings for Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema (NCT NCT00490815)
NCT ID: NCT00490815
Last Updated: 2014-02-13
Results Overview
This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
37 participants
Primary outcome timeframe
over 36 months
Results posted on
2014-02-13
Participant Flow
Participant milestones
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
Dose 0.2 ug/day Medidur Implant administered in one eye
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
Dose 0.5 ug/day Medidur Implant administered in one eye
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
COMPLETED
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
Dose 0.2 ug/day Medidur Implant administered in one eye
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
Dose 0.5 ug/day Medidur Implant administered in one eye
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Death
|
1
|
3
|
Baseline Characteristics
Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
n=20 Participants
Dose 0.2 ug/day Medidur Implant
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
n=17 Participants
Dose 0.5 ug/day Medidur Implant
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
67.4 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: over 36 monthsThis was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.
Outcome measures
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
n=12 Participants
Dose 0.2 ug/day Medidur Implant
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
n=8 Participants
Dose 0.5 ug/day Medidur Implant
|
|---|---|---|
|
Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor
|
1.4905 pg/ml
Standard Deviation 1.87058
|
0.7140 pg/ml
Standard Deviation 0.78096
|
SECONDARY outcome
Timeframe: over 36 monthsOutcome measures
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
n=20 Participants
Dose 0.2 ug/day Medidur Implant
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
n=17 Participants
Dose 0.5 ug/day Medidur Implant
|
|---|---|---|
|
Retinal Thickness
|
343.8 µg
Standard Deviation 142.92
|
324.2 µg
Standard Deviation 136.86
|
Adverse Events
Fluocinolone Acetonide: 0.2 ug/Day Implant
Serious events: 19 serious events
Other events: 20 other events
Deaths: 0 deaths
Fluocinolone Acetonide: 0.5 ug/Day Implant
Serious events: 12 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
n=20 participants at risk
Dose 0.2 ug/day Medidur Implant
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
n=17 participants at risk
Dose 0.5 ug/day Medidur Implant
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/20
|
11.8%
2/17 • Number of events 2
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
10.0%
2/20 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Glaucoma
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
General disorders
Chest pain
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Blood glucose increased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/20
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
15.0%
3/20 • Number of events 6
|
0.00%
0/17
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Surgical and medical procedures
Cataract operation
|
25.0%
5/20 • Number of events 5
|
23.5%
4/17 • Number of events 4
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Surgical and medical procedures
Colectomy
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Surgical and medical procedures
Glaucoma surgery
|
0.00%
0/20
|
11.8%
2/17 • Number of events 2
|
|
Surgical and medical procedures
Retinal operation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Surgical and medical procedures
Trabeculectomy
|
5.0%
1/20 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
|
Surgical and medical procedures
Vitrectomy
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
Other adverse events
| Measure |
Fluocinolone Acetonide: 0.2 ug/Day Implant
n=20 participants at risk
Dose 0.2 ug/day Medidur Implant
|
Fluocinolone Acetonide: 0.5 ug/Day Implant
n=17 participants at risk
Dose 0.5 ug/day Medidur Implant
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Cardiac disorders
Aortic valve stenosis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Cardiac disorders
Arrhythmia
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Cardiac valve disease
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Cardiac disorders
Coronary artery disease
|
10.0%
2/20 • Number of events 2
|
0.00%
0/17
|
|
Cardiac disorders
Left ventricular hypertrophy
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Cardiac disorders
Myocardial ischaemia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Cardiac disorders
Sick sinus syndrome
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/20
|
5.9%
1/17 • Number of events 2
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Asthenopia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Cataract
|
30.0%
6/20 • Number of events 6
|
23.5%
4/17 • Number of events 4
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Cataract subcapsular
|
5.0%
1/20 • Number of events 1
|
17.6%
3/17 • Number of events 4
|
|
Eye disorders
Conjunctival haemorrhage
|
35.0%
7/20 • Number of events 8
|
41.2%
7/17 • Number of events 9
|
|
Eye disorders
Conjunctival hyperaemia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Corneal oedema
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Dry eye
|
5.0%
1/20 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
|
Eye disorders
Eye irritation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Eye pain
|
15.0%
3/20 • Number of events 3
|
0.00%
0/17
|
|
Eye disorders
Eye pruritus
|
5.0%
1/20 • Number of events 2
|
0.00%
0/17
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Foreign body sensation in eyes
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Glaucoma
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 2
|
|
Eye disorders
Iris atrophy
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Iris neovascularisation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Lacrimation increased
|
5.0%
1/20 • Number of events 1
|
17.6%
3/17 • Number of events 3
|
|
Eye disorders
Macular hole
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Macular ischaemia
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Maculopathy
|
10.0%
2/20 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Myodesopsia
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
5.0%
1/20 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
|
Eye disorders
Optic atrophy
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Photophobia
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Photopsia
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Retinal aneurysm
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Retinal vascular occlusion
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Vision blurred
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Eye disorders
Visual impairment
|
0.00%
0/20
|
11.8%
2/17 • Number of events 2
|
|
Eye disorders
Vitreous detachment
|
10.0%
2/20 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Vitreous haemorrhage
|
15.0%
3/20 • Number of events 3
|
5.9%
1/17 • Number of events 5
|
|
Gastrointestinal disorders
Colonic polyp
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 2
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Diverticulum
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Duodenal ulcer
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal mass
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Peptic ulcer
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20
|
11.8%
2/17 • Number of events 2
|
|
General disorders
Chest discomfort
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Chest pain
|
10.0%
2/20 • Number of events 2
|
0.00%
0/17
|
|
General disorders
Fatigue
|
10.0%
2/20 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Immune system disorders
Seasonal allergy
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Blister infected
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Gingival infection
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Hordeolum
|
5.0%
1/20 • Number of events 2
|
0.00%
0/17
|
|
Infections and infestations
Infected bites
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Influenza
|
20.0%
4/20 • Number of events 4
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Localised infection
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20
|
11.8%
2/17 • Number of events 2
|
|
Infections and infestations
Sepsis
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
5.0%
1/20 • Number of events 2
|
0.00%
0/17
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20
|
11.8%
2/17 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
1/20 • Number of events 1
|
11.8%
2/17 • Number of events 3
|
|
Injury, poisoning and procedural complications
Fall
|
15.0%
3/20 • Number of events 5
|
11.8%
2/17 • Number of events 3
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
5.0%
1/20 • Number of events 2
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Postoperative renal failure
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Blood cholesterol increased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Haematocrit decreased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Haemoglobin decreased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Intraocular pressure increased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Optic nerve cup/disc ratio increased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Red blood cell count decreased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Investigations
White blood cell count increased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.0%
1/20 • Number of events 2
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Fluid retention
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/20
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Obesity
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
5.0%
1/20 • Number of events 2
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
2/20 • Number of events 3
|
11.8%
2/17 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • Number of events 2
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
10.0%
2/20 • Number of events 3
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Amnesia
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Neuralgia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
2/20 • Number of events 3
|
0.00%
0/17
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Visual field defect
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Psychiatric disorders
Anticipatory anxiety
|
0.00%
0/20
|
5.9%
1/17 • Number of events 3
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Renal and urinary disorders
Nephrosclerosis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Renal and urinary disorders
Renal failure chronic
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Allergic respiratory symptom
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Number of events 2
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 1
|
11.8%
2/17 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/20
|
11.8%
2/17 • Number of events 2
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
Additional Information
Kathleen Billman, Senior Director of Scientific Affairs
Alimera Sciences, Inc
Phone: 678-527-1302
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60