Trial Outcomes & Findings for Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina (NCT NCT00770770)
NCT ID: NCT00770770
Last Updated: 2015-05-28
Results Overview
To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
3 months
Results posted on
2015-05-28
Participant Flow
Participant milestones
| Measure |
Fluocinolone Acetonide: 0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/day
|
Fluocinolone Acetonide: 0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/day
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
10
|
1
|
Reasons for withdrawal
| Measure |
Fluocinolone Acetonide: 0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/day
|
Fluocinolone Acetonide: 0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/day
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Study Terminated
|
8
|
0
|
Baseline Characteristics
Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
Baseline characteristics by cohort
| Measure |
Fluocinolone Acetonide 0.2 µg/Day
n=14 Participants
0.2 µg/day
Fluocinolone Acetonide: 0.2 µg/day
|
Fluocinolone Acetonide 0.5 µg/Day
n=6 Participants
0.5 µg/day
Fluocinolone Acetonide: 0.5 µg/day
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.50 years
STANDARD_DEVIATION 9.287 • n=93 Participants
|
73.52 years
STANDARD_DEVIATION 13.091 • n=4 Participants
|
69.30 years
STANDARD_DEVIATION 10.589 • n=27 Participants
|
|
Age, Customized
<35 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Age, Customized
35-45 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Age, Customized
45-55 years
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Age, Customized
55-65 years
|
3 participants
n=93 Participants
|
2 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Age, Customized
65-75 years
|
6 participants
n=93 Participants
|
0 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Age, Customized
75-85 years
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Age, Customized
≥85 years
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
6 participants
n=4 Participants
|
20 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 monthsTo compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.
Outcome measures
| Measure |
Fluocinolone Acetonide 0.2 µg/Day
n=14 Participants
0.2 µg/day
Fluocinolone Acetonide: 0.2 µg/day
|
Fluocinolone Acetonide 0.5 µg/Day
n=6 Participants
0.5 µg/day
Fluocinolone Acetonide: 0.5 µg/day
|
|---|---|---|
|
Visual Acuity
Baseline
|
47.0 Letters
Standard Error 4.50
|
53.5 Letters
Standard Error 4.13
|
|
Visual Acuity
Month 3 - Change from Baseline
|
7.0 Letters
Standard Error 2.51
|
9.2 Letters
Standard Error 2.37
|
Adverse Events
Fluocinolone Acetonide: 0.2 µg/Day
Serious events: 8 serious events
Other events: 13 other events
Deaths: 0 deaths
Fluocinolone Acetonide: 0.5 µg/Day
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluocinolone Acetonide: 0.2 µg/Day
n=14 participants at risk
Fluocinolone Acetonide: 0.2 µg/day
|
Fluocinolone Acetonide: 0.5 µg/Day
n=6 participants at risk
Fluocinolone Acetonide: 0.5 µg/day
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
14.3%
2/14 • Number of events 2
|
0.00%
0/6
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/14
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Pseudomonas infection
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Cerebrovascular accident
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Major depression
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Mental disorder
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Renal and urinary disorders
Bladder obstruction
|
7.1%
1/14 • Number of events 2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Surgical and medical procedures
Cataract operation
|
14.3%
2/14 • Number of events 2
|
0.00%
0/6
|
Other adverse events
| Measure |
Fluocinolone Acetonide: 0.2 µg/Day
n=14 participants at risk
Fluocinolone Acetonide: 0.2 µg/day
|
Fluocinolone Acetonide: 0.5 µg/Day
n=6 participants at risk
Fluocinolone Acetonide: 0.5 µg/day
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
1/14 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
14.3%
2/14 • Number of events 2
|
0.00%
0/6
|
|
Cardiac disorders
Cardiac failure congestive
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/14
|
16.7%
1/6 • Number of events 1
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/14
|
16.7%
1/6 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Cataract
|
21.4%
3/14 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Cataract subcapsular
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Conjunctival haemorrhage
|
7.1%
1/14 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Diabetic retinopathy
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Diplopia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Dry eye
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Eye irritation
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Eye pain
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Iris neovascularisation
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Myodesopsia
|
14.3%
2/14 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
14.3%
2/14 • Number of events 2
|
0.00%
0/6
|
|
Eye disorders
Optic atrophy
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Optic disc haemorrhage
|
0.00%
0/14
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Optic disc vascular disorder
|
7.1%
1/14 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Papilloedema
|
0.00%
0/14
|
16.7%
1/6 • Number of events 2
|
|
Eye disorders
Photophobia
|
14.3%
2/14 • Number of events 2
|
0.00%
0/6
|
|
Eye disorders
Photopsia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Retinal aneurysm
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Retinal haemorrhage
|
7.1%
1/14 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Retinal neovascularisation
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Retinal oedema
|
0.00%
0/14
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Visual acuity reduced
|
7.1%
1/14 • Number of events 2
|
0.00%
0/6
|
|
Eye disorders
Vitreous detachment
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
21.4%
3/14 • Number of events 4
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
14.3%
2/14 • Number of events 3
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
14.3%
2/14 • Number of events 2
|
0.00%
0/6
|
|
General disorders
Sensation of foreign body
|
14.3%
2/14 • Number of events 2
|
0.00%
0/6
|
|
Infections and infestations
Bronchitis
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Ear infection
|
0.00%
0/14
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Pseudomonas infection
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Sinusitis
|
14.3%
2/14 • Number of events 3
|
0.00%
0/6
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Urinary tract infection
|
21.4%
3/14 • Number of events 6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
7.1%
1/14 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/14
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Intraocular pressure increased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/14
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 2
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Hemianopia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Renal and urinary disorders
Bladder obstruction
|
7.1%
1/14 • Number of events 3
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/14
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
7.1%
1/14 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/14
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 2
|
0.00%
0/6
|
Additional Information
Kathleen Billman, Senior Director, 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