Trial Outcomes & Findings for Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy (NCT NCT00695318)
NCT ID: NCT00695318
Last Updated: 2015-05-29
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
24 months
Results posted on
2015-05-29
Participant Flow
Participant milestones
| Measure |
A, 2, I 0.2 µg/Day + Sham
0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/Day
|
A, 2, II 0.5 µg/Day + Sham
0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/Day
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
7
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
A, 2, I 0.2 µg/Day + Sham
0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/Day
|
A, 2, II 0.5 µg/Day + Sham
0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/Day
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Study Terminated
|
1
|
0
|
Baseline Characteristics
Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
Baseline characteristics by cohort
| Measure |
A, 2, I 0.2 µg/Day + Sham
n=10 Participants
0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/Day + Sham treatment in fellow eye
|
A, 2, II 0.5 µg/Day + Sham
n=7 Participants
0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/Day + Sham treatment in fellow eye
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.95 years
STANDARD_DEVIATION 8.976 • n=5 Participants
|
82.55 years
STANDARD_DEVIATION 6.056 • n=7 Participants
|
81.02 years
STANDARD_DEVIATION 7.799 • n=5 Participants
|
|
Age, Customized
<35 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
35-44 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
45-54 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
55-64 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
65-74 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Age, Customized
75-84 years
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Age, Customized
≥85 years
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Patients received either a 0.2µg/Day or 0.5 µg/Day treatment in the study eye and a sham treatment in the fellow eye.
Outcome measures
| Measure |
A, 2, I Sham
n=8 Participants
|
A, 2, I 0.2 µg/Day
n=8 Participants
0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/Day
|
A, 2, II Sham
n=6 Participants
|
A, 2, II 0.5 µg/Day
n=6 Participants
0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/Day
|
|---|---|---|---|---|
|
Change From Baseline in Size of Geographic Atrophy
|
2.513 mm3/year
Standard Deviation 1.5318
|
2.758 mm3/year
Standard Deviation 1.7830
|
2.599 mm3/year
Standard Deviation 2.4005
|
2.562 mm3/year
Standard Deviation 1.9685
|
Adverse Events
Sham Injection
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
0.2 ug/Day
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
0.5 ug/Day
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
0.2 ug/Day + Sham Injection
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
0.5 ug/Day + Sham Injection
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sham Injection
n=17 participants at risk
Sham Injection
Sham Injection: Sham injection
Ocular AEs
|
0.2 ug/Day
n=10 participants at risk
0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/Day
Ocular AEs
|
0.5 ug/Day
n=7 participants at risk
0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/Day
Ocular AEs
|
0.2 ug/Day + Sham Injection
n=10 participants at risk
Fluocinolone Acetonide: 0.2 µg/Day + Sham Injection
Systemic AEs
|
0.5 ug/Day + Sham Injection
n=7 participants at risk
Fluocinolone Acetonide: 0.5 µg/Day + Sham Injection
Systemic AEs
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Cardiac disorders
Myocardial infarction
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Cardiac disorders
Ventricular tachycardia
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Infections and infestations
Sepsis
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Nervous system disorders
Cerebral haemorrhage
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Nervous system disorders
Cerebrovascular accident
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Renal and urinary disorders
Renal mass
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Surgical and medical procedures
Cataract operation
|
17.6%
3/17 • Number of events 3
Each patient received a sham injection in one eye and active treatment in the other eye.
|
30.0%
3/10 • Number of events 3
Each patient received a sham injection in one eye and active treatment in the other eye.
|
28.6%
2/7 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
Other adverse events
| Measure |
Sham Injection
n=17 participants at risk
Sham Injection
Sham Injection: Sham injection
Ocular AEs
|
0.2 ug/Day
n=10 participants at risk
0.2 µg/Day
Fluocinolone Acetonide: 0.2 µg/Day
Ocular AEs
|
0.5 ug/Day
n=7 participants at risk
0.5 µg/Day
Fluocinolone Acetonide: 0.5 µg/Day
Ocular AEs
|
0.2 ug/Day + Sham Injection
n=10 participants at risk
Fluocinolone Acetonide: 0.2 µg/Day + Sham Injection
Systemic AEs
|
0.5 ug/Day + Sham Injection
n=7 participants at risk
Fluocinolone Acetonide: 0.5 µg/Day + Sham Injection
Systemic AEs
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Infections and infestations
Urinary tract infection
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
20.0%
2/10 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Infections and infestations
Pneumonia
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
20.0%
2/10 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Cardiac disorders
Cardiac failure congestive
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Blepharitis
|
5.9%
1/17 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Cataract
|
17.6%
3/17 • Number of events 3
Each patient received a sham injection in one eye and active treatment in the other eye.
|
30.0%
3/10 • Number of events 4
Each patient received a sham injection in one eye and active treatment in the other eye.
|
28.6%
2/7 • Number of events 3
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Cataract subcapsular
|
5.9%
1/17 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Choroidal neovascularisation
|
0.00%
0/17
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Conjunctival haemorrhage
|
11.8%
2/17 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
20.0%
2/10 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Conjunctival hyperaemia
|
5.9%
1/17 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
20.0%
2/10 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Dacryostenosis acquired
|
5.9%
1/17 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Dry eye
|
11.8%
2/17 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Eye irritation
|
0.00%
0/17
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Eye pain
|
0.00%
0/17
Each patient received a sham injection in one eye and active treatment in the other eye.
|
20.0%
2/10 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Eyelid ptosis
|
5.9%
1/17 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Myodesopsia
|
0.00%
0/17
Each patient received a sham injection in one eye and active treatment in the other eye.
|
20.0%
2/10 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Photophobia
|
5.9%
1/17 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Posterior capsule opacification
|
5.9%
1/17 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Punctate keratitis
|
29.4%
5/17 • Number of events 7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
30.0%
3/10 • Number of events 3
Each patient received a sham injection in one eye and active treatment in the other eye.
|
42.9%
3/7 • Number of events 5
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Retinal pigment epithelial tear
|
0.00%
0/17
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Vision blurred
|
5.9%
1/17 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Visual impairment
|
5.9%
1/17 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
20.0%
2/10 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/17
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Investigations
Heart rate irregular
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Investigations
Intraocular pressure increased
|
5.9%
1/17 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
42.9%
3/7 • Number of events 3
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 2
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Renal and urinary disorders
Nephrolithiasis
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/10
Each patient received a sham injection in one eye and active treatment in the other eye.
|
14.3%
1/7 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Skin and subcutaneous tissue disorders
Cutis laxa
|
5.9%
1/17 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
|
Vascular disorders
Phlebitis
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
—
0/0
Each patient received a sham injection in one eye and active treatment in the other eye.
|
10.0%
1/10 • Number of events 1
Each patient received a sham injection in one eye and active treatment in the other eye.
|
0.00%
0/7
Each patient received a sham injection in one eye and active treatment in the other eye.
|
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