Trial Outcomes & Findings for Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO (NCT NCT03203447)
NCT ID: NCT03203447
Last Updated: 2021-04-23
Results Overview
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
325 participants
Primary outcome timeframe
2 months
Results posted on
2021-04-23
Participant Flow
Participant milestones
| Measure |
Active
Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
Control
Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
suprachoroidal sham: sham suprachoroidal procedure
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
|---|---|---|
|
Overall Study
STARTED
|
162
|
163
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
162
|
163
|
Reasons for withdrawal
| Measure |
Active
Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
Control
Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
suprachoroidal sham: sham suprachoroidal procedure
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
10
|
|
Overall Study
Includes premature discontinuation due to study termination and unknown
|
159
|
152
|
Baseline Characteristics
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO
Baseline characteristics by cohort
| Measure |
Active
n=160 Participants
Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
Control
n=162 Participants
Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
suprachoroidal sham: sham suprachoroidal procedure
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
Total
n=322 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
166 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
85 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 13.07 • n=99 Participants
|
62.6 years
STANDARD_DEVIATION 12.26 • n=107 Participants
|
63.2 years
STANDARD_DEVIATION 12.66 • n=206 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
72 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
96 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
194 Participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
India
|
60 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Type of Retinal Vein Occlusion
Branch retinal vein occlusion
|
90 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
183 Participants
n=206 Participants
|
|
Type of Retinal Vein Occlusion
Central retinal vein occlusion
|
70 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: The Intent-to-treat population included all randomized patients. Values for missing data were imputed using last observation carried forward.
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
Outcome measures
| Measure |
Active
n=162 Participants
Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
Control
n=163 Participants
Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
suprachoroidal sham: sham suprachoroidal procedure
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
|---|---|---|
|
Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
|
64 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Intent-to-treat population included all randomized subjects who received at least one study treatment. Values for missing data were not imputed.
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.
Outcome measures
| Measure |
Active
n=160 Participants
Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
Control
n=159 Participants
Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
suprachoroidal sham: sham suprachoroidal procedure
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity
|
13.8 letters
Standard Error 1.96
|
20.7 letters
Standard Error 1.91
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Intent-to-treat population included all randomized subjects who received at least one study treatment. Values for missing data were not imputed.
Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.
Outcome measures
| Measure |
Active
n=162 Participants
Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
Control
n=159 Participants
Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
suprachoroidal sham: sham suprachoroidal procedure
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
|---|---|---|
|
Mean Change From Baseline in Central Subfield Thickness
|
-353.6 microns
Standard Error 19.60
|
-374.7 microns
Standard Error 19.12
|
Adverse Events
Active
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Control
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active
n=160 participants at risk
Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
Control
n=162 participants at risk
Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
suprachoroidal sham: sham suprachoroidal procedure
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.62%
1/160 • Number of events 1 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
0.00%
0/162 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/160 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/160 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/160 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/160 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/160 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.62%
1/160 • Number of events 1 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
0.00%
0/162 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/160 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
Other adverse events
| Measure |
Active
n=160 participants at risk
Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
Control
n=162 participants at risk
Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
suprachoroidal sham: sham suprachoroidal procedure
Lucentis or Avastin: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
|
|---|---|---|
|
Investigations
Intraocular pressure increased
|
6.9%
11/160 • Number of events 14 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected through follow-up and study completion, approximately 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The institutions and Investigators participating in this study shall have no right to publish or present the results of this study without the prior written consent of Clearside Biomedical, Inc.
- Publication restrictions are in place
Restriction type: OTHER