Trial Outcomes & Findings for MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301 (NCT NCT02952001)
NCT ID: NCT02952001
Last Updated: 2021-06-02
Results Overview
This time to event outcome was calculated as the number of days between the date of initiation of additional therapy for uveitis and the date of first treatment in the Parent study CLS1001-301 (NCT02595398).
Recruitment status
COMPLETED
Target enrollment
33 participants
Primary outcome timeframe
6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year
Results posted on
2021-06-02
Participant Flow
Subjects enrolled into the Parent study CLS1001-301 (NCT02595398), and who completed the Parent study without receiving additional therapy for uveitis were eligible for enrollment into this non-interventional observation extension study. The Parent study was still masked when subjects started enrolling into this extension study, therefore, treatment assignment was unknown at study entry and during the study.
Subjects enrolled into this non-interventional observational extension study successfully completed the Parent study CLS1001-301 (NCT02595398) without requiring additional therapy for uveitis. In the Parent study, subjects were randomized 3:2 to either 4 mg CLS-TA or a sham procedure in a masked fashion. Eligible and consenting subjects from selected sites were enrolled into the non-interventional extension study.
Participant milestones
| Measure |
4 mg CLS-TA Suprachoriodal Injection
Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
Sham Procedure
Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
5
|
|
Overall Study
COMPLETED
|
14
|
2
|
|
Overall Study
NOT COMPLETED
|
14
|
3
|
Reasons for withdrawal
| Measure |
4 mg CLS-TA Suprachoriodal Injection
Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
Sham Procedure
Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Prohibited therapy
|
10
|
3
|
|
Overall Study
Due to Posterior Capsular Opacity
|
1
|
0
|
Baseline Characteristics
MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301
Baseline characteristics by cohort
| Measure |
4 mg CLS-TA Suprachoriodal Injection
n=28 Participants
Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
Sham Procedure
n=5 Participants
Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Continuous
|
48.57 years
STANDARD_DEVIATION 15.039 • n=93 Participants
|
51.20 years
STANDARD_DEVIATION 15.818 • n=4 Participants
|
48.97 years
STANDARD_DEVIATION 14.934 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
3 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Region of Enrollment
India
|
20 participants
n=93 Participants
|
2 participants
n=4 Participants
|
22 participants
n=27 Participants
|
|
Type of Uveitis
Anterior uveitis
|
10 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Type of Uveitis
Intermediate uveitis
|
9 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Type of Uveitis
Posterior uveitis
|
11 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Type of Uveitis
Panuveitis
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 yearPopulation: The Safety population included all enrolled subjects who successfully completed the enrollment visit of the extension study.
This time to event outcome was calculated as the number of days between the date of initiation of additional therapy for uveitis and the date of first treatment in the Parent study CLS1001-301 (NCT02595398).
Outcome measures
| Measure |
4 mg CLS-TA Suprachoriodal Injection
n=28 Participants
Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation i the Parent study without receiving additional therapy. No study drug was administered during this study.
4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
Sham Procedure
n=5 Participants
Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
|---|---|---|
|
Time to Additional Therapy for Uveitis
|
344.0 days
Interval 282.0 to
Not enough participants achieved response to calculate upper 95% CI
|
332.0 days
Interval 280.0 to
Not enough participants achieved response to calculate upper 95% CI
|
SECONDARY outcome
Timeframe: 6 months following exit from Parent studyPopulation: The Safety population included all enrolled subjects who successfully completed the enrollment visit of the extension study.
Number of participants with treatment emergent adverse events and serious adverse events reported during the extension study.
Outcome measures
| Measure |
4 mg CLS-TA Suprachoriodal Injection
n=28 Participants
Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation i the Parent study without receiving additional therapy. No study drug was administered during this study.
4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
Sham Procedure
n=5 Participants
Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Treatment-emergent adverse events
|
16 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Serious adverse events
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months following exit from Parent studyPopulation: The Safety population included all enrolled subjects who successfully completed the enrollment visit of the extension study. Results include those subjects with gradable images at follow-up week 24. 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 |
4 mg CLS-TA Suprachoriodal Injection
n=13 Participants
Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation i the Parent study without receiving additional therapy. No study drug was administered during this study.
4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
Sham Procedure
n=2 Participants
Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
|---|---|---|
|
Mean Change From Baseline in Central Subfield Thickness
|
-174.5 microns
Standard Deviation 145.70
|
19.5 microns
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: 6 months following exit from Parent studyPopulation: The Safety population included all enrolled subjects who successfully completed the enrollment visit of the extension study. Results include those subjects with non-missing BCVA values at follow-up week 24. 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. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
Outcome measures
| Measure |
4 mg CLS-TA Suprachoriodal Injection
n=14 Participants
Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation i the Parent study without receiving additional therapy. No study drug was administered during this study.
4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
Sham Procedure
n=2 Participants
Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity
|
12.1 letters
Standard Deviation 13.00
|
14.0 letters
Standard Deviation 15.56
|
Adverse Events
4 mg CLS-TA Suprachoriodal Injection
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Sham Procedure
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
4 mg CLS-TA Suprachoriodal Injection
n=28 participants at risk
Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
Sham Procedure
n=5 participants at risk
Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
|---|---|---|
|
Gastrointestinal disorders
Oesophageal achalasia
|
3.6%
1/28 • Number of events 1 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
0.00%
0/5 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • Number of events 2 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
0.00%
0/5 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Infections and infestations
Septic shock
|
3.6%
1/28 • Number of events 1 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
0.00%
0/5 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
1/28 • Number of events 1 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
0.00%
0/5 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.6%
1/28 • Number of events 3 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
0.00%
0/5 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
3.6%
1/28 • Number of events 2 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
0.00%
0/5 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
Other adverse events
| Measure |
4 mg CLS-TA Suprachoriodal Injection
n=28 participants at risk
Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
Sham Procedure
n=5 participants at risk
Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study.
Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
|
|---|---|---|
|
Infections and infestations
Infection parasitic
|
0.00%
0/28 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
20.0%
1/5 • Number of events 1 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/28 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
20.0%
1/5 • Number of events 1 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Eye disorders
Cataract
|
7.1%
2/28 • Number of events 2 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
0.00%
0/5 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Eye disorders
Cataract cortical
|
0.00%
0/28 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
20.0%
1/5 • Number of events 1 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Eye disorders
Cataract subcapsular
|
17.9%
5/28 • Number of events 5 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
0.00%
0/5 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/28 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
20.0%
1/5 • Number of events 1 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Eye disorders
Macular oedema
|
3.6%
1/28 • Number of events 1 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
20.0%
1/5 • Number of events 1 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Eye disorders
Uveitis
|
7.1%
2/28 • Number of events 3 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
0.00%
0/5 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Investigations
Intraocular pressure increased
|
10.7%
3/28 • Number of events 3 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
0.00%
0/5 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
|
Eye disorders
Eye pain
|
7.1%
2/28 • Number of events 2 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
0.00%
0/5 • 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
|
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 Biomedical.
- Publication restrictions are in place
Restriction type: OTHER