Trial Outcomes & Findings for Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis (NCT NCT02255032)
NCT ID: NCT02255032
Last Updated: 2021-02-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
2 months
Results posted on
2021-02-08
Participant Flow
Participant milestones
| Measure |
4 mg CLS-TA
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
|
0.8 mg CLS-TA
Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
5
|
|
Overall Study
COMPLETED
|
17
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis
Baseline characteristics by cohort
| Measure |
4 mg CLS-TA
n=17 Participants
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
|
0.8 mg CLS-TA
n=5 Participants
Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
|
Total
n=22 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
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
52.2 Years
STANDARD_DEVIATION 19.65 • n=5 Participants
|
51.8 Years
STANDARD_DEVIATION 16.87 • n=7 Participants
|
52.1 Years
STANDARD_DEVIATION 18.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
5 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Intent-to-Treat set includes all randomly assigned subjects who received at least one dose of study drug.
Outcome measures
| Measure |
4 mg CLS-TA
n=16 Participants
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
|
0.8 mg CLS-TA
n=5 Participants
Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
|
|---|---|---|
|
Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis
|
-164.44 Microns
Standard Deviation 173.148
|
-78.20 Microns
Standard Deviation 121.890
|
Adverse Events
4 mg CLS-TA
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
0.8 mg CLS-TA
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
4 mg CLS-TA
n=17 participants at risk
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
|
0.8 mg CLS-TA
n=5 participants at risk
Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
Other adverse events
| Measure |
4 mg CLS-TA
n=17 participants at risk
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
|
0.8 mg CLS-TA
n=5 participants at risk
Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Eye disorders
Anterior chamber cell
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Eye disorders
Anterior chamber inflammation
|
0.00%
0/17 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Eye disorders
Blindness transient
|
0.00%
0/17 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Eye disorders
Conjunctival oedema
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Eye disorders
Dry eye
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Eye disorders
Eye pain
|
17.6%
3/17 • Number of events 3 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Eye disorders
Foreign body sensation in eyes
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Eye disorders
Keratitis
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Eye disorders
Macular oedema
|
11.8%
2/17 • Number of events 2 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Eye disorders
Ocular discomfort
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Eye disorders
Punctate keratitis
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/17 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Eye disorders
Uveitis
|
17.6%
3/17 • Number of events 3 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Eye disorders
Visual acuity reduced
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
General disorders
Injection site pain
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
General disorders
Papillitis
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Infections and infestations
Gastrointestinal infection
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/17 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/17 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Investigations
Blood pressure diastolic increased
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Investigations
Blood pressure systolic increased
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Investigations
Heart rate decreased
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Investigations
Intraocular pressure increased
|
5.9%
1/17 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
5.9%
1/17 • Number of events 2 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Number of events 2 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The institution and investigators participating in this trial shall have no right to publish or present the results of this study without the prior written consent of Clearside.
- Publication restrictions are in place
Restriction type: OTHER