Trial Outcomes & Findings for Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO (NCT NCT02303184)
NCT ID: NCT02303184
Last Updated: 2021-02-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
3 months
Results posted on
2021-02-08
Participant Flow
Participant milestones
| Measure |
Suprachoroidal CLS-TA + IVT Aflibercept
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA
IVT aflibercept: 2 mg intravitreal injection of aflibercept
|
Suprachoroidal Sham + IVT Aflibercept
Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
suprachoroidal sham: suprachoroidal sham procedure
IVT aflibercept: 2 mg intravitreal injection of aflibercept
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Baseline characteristics by cohort
| Measure |
Suprachoroidal CLS-TA + IVT Aflibercept
n=23 Participants
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA
IVT aflibercept: 2 mg intravitreal injection of aflibercept
|
Suprachoroidal Sham + IVT Aflibercept
n=23 Participants
Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
suprachoroidal sham: suprachoroidal sham procedure
IVT aflibercept: 2 mg intravitreal injection of aflibercept
|
Total
n=46 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
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Continuous
|
66.9 Years
STANDARD_DEVIATION 12.02 • n=5 Participants
|
65.8 Years
STANDARD_DEVIATION 14.64 • n=7 Participants
|
66.3 Years
STANDARD_DEVIATION 12.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: The Intent-to-Treat set included all randomly assigned subjects who were treated and had at least one post-Baseline assessment.
Outcome measures
| Measure |
Suprachoroidal CLS-TA + IVT Aflibercept
n=23 Participants
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA
IVT aflibercept: 2 mg intravitreal injection of aflibercept
|
Suprachoroidal Sham + IVT Aflibercept
n=23 Participants
Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
suprachoroidal sham: suprachoroidal sham procedure
IVT aflibercept: 2 mg intravitreal injection of aflibercept
|
|---|---|---|
|
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
0
|
18 Participants
|
7 Participants
|
|
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
1
|
3 Participants
|
12 Participants
|
|
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
2
|
0 Participants
|
1 Participants
|
|
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
3
|
2 Participants
|
3 Participants
|
Adverse Events
Suprachoroidal CLS-TA + IVT Aflibercept
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Suprachoroidal Sham + IVT Aflibercept
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Suprachoroidal CLS-TA + IVT Aflibercept
n=23 participants at risk
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA
IVT aflibercept: 2 mg intravitreal injection of aflibercept
|
Suprachoroidal Sham + IVT Aflibercept
n=23 participants at risk
Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
suprachoroidal sham: suprachoroidal sham procedure
IVT aflibercept: 2 mg intravitreal injection of aflibercept
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/23 • 3 months
|
|
Eye disorders
Cataract
|
0.00%
0/23 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
|
Eye disorders
Conjunctival haemorrhage
|
8.7%
2/23 • Number of events 2 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
|
Eye disorders
Conjunctival hyperaemia
|
8.7%
2/23 • Number of events 2 • 3 months
|
0.00%
0/23 • 3 months
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/23 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
|
Eye disorders
Corneal oedema
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/23 • 3 months
|
|
Eye disorders
Eye pain
|
34.8%
8/23 • Number of events 9 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
|
Eye disorders
Foreign body sensation in eyes
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/23 • 3 months
|
|
Eye disorders
Lacrimation increased
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/23 • 3 months
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/23 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/23 • 3 months
|
8.7%
2/23 • Number of events 2 • 3 months
|
|
Eye disorders
Ocular hypertension
|
8.7%
2/23 • Number of events 2 • 3 months
|
0.00%
0/23 • 3 months
|
|
Eye disorders
Optic disc vascular disorder
|
0.00%
0/23 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
|
Eye disorders
Optic nerve disorder
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/23 • 3 months
|
|
Eye disorders
Punctate keratitis
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/23 • 3 months
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/23 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
|
Eye disorders
Retinal exudates
|
4.3%
1/23 • Number of events 1 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
|
Eye disorders
Retinal haemorrhage
|
4.3%
1/23 • Number of events 2 • 3 months
|
0.00%
0/23 • 3 months
|
|
Eye disorders
Retinopathy
|
0.00%
0/23 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/23 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/23 • 3 months
|
8.7%
2/23 • Number of events 2 • 3 months
|
|
Eye disorders
Vitreous detachment
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/23 • 3 months
|
|
Eye disorders
Vitreous floaters
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/23 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/23 • 3 months
|
|
Investigations
Intraocular pressure increased
|
8.7%
2/23 • Number of events 2 • 3 months
|
0.00%
0/23 • 3 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/23 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 2 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/23 • 3 months
|
|
Vascular disorders
Hypertension
|
17.4%
4/23 • Number of events 4 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
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