Trial · NCT02595398

Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis

NCT02595398, Phase 3, Completed, Clearside Biomedical, Inc.; results first posted 2021-04-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis. Trials, record NCT02595398. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02595398

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis
NCT number: NCT02595398
Status: Completed
Phases: Phase 3
Enrollment: 160 participants, actual
Lead sponsor: Clearside Biomedical, Inc.
Conditions: Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis
Interventions: 4mg CLS-TA Suprachoriodal Injection, Sham Procedure
First posted: 2015-11-03
Last updated: 2021-05-28
Results first posted: 2021-04-28

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks	Baseline, 24 weeks	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 electronic Visual Acuity (eVA). An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
Secondary	Mean Change From Baseline in Central Subfield Thickness	Baseline, 24 weeks	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. Only images that were gradable by the central reading center were included in the analysis.
Secondary	Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Baseline to 24 weeks	Number of subjects with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported between the first dose of study drug and study exit.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks	Baseline, 24 weeks	The Intent-to-treat population included all randomized subjects who received at least one study treatment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Change From Baseline in Central Subfield Thickness	Baseline, 24 weeks	The Intent-to-treat population included all randomized subjects who received at least one study treatment. Analysis included all subjects with gradable reading center images.	microns	MEAN
SECONDARY	Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Baseline to 24 weeks	The Safety population included all randomized subjects who were administered at least one dose of the study drug.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks	4mg CLS-TA Suprachoriodal Injection		45		Participants
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks	Sham Procedure		10		Participants
Mean Change From Baseline in Central Subfield Thickness	4mg CLS-TA Suprachoriodal Injection		-152.6	Standard Deviation 159.14	microns
Mean Change From Baseline in Central Subfield Thickness	Sham Procedure		-17.9	Standard Deviation 150.98	microns
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	4mg CLS-TA Suprachoriodal Injection	Experiencing at least one TEAE	67		Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Sham Procedure	Experiencing at least one TEAE	45		Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	4mg CLS-TA Suprachoriodal Injection	Experiencing at least one SAE	3		Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Sham Procedure	Experiencing at least one SAE	0		Participants

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	4mg CLS-TA Suprachoriodal Injection	96
Overall Study	STARTED	Sham Procedure	64
Overall Study	Intention-to-Treat (ITT) Population	4mg CLS-TA Suprachoriodal Injection	96
Overall Study	Intention-to-Treat (ITT) Population	Sham Procedure	64
Overall Study	Safety Population	4mg CLS-TA Suprachoriodal Injection	96
Overall Study	Safety Population	Sham Procedure	64
Overall Study	COMPLETED	4mg CLS-TA Suprachoriodal Injection	92
Overall Study	COMPLETED	Sham Procedure	63
Overall Study	NOT COMPLETED	4mg CLS-TA Suprachoriodal Injection	4
Overall Study	NOT COMPLETED	Sham Procedure	1

Source ClinicalTrials.gov

Adverse events22

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	4mg CLS-TA Suprachoriodal Injection	5	96	5
other	Headache	Nervous system disorders	Sham Procedure	2	64	2
other	Cataract subcapsular	Eye disorders	4mg CLS-TA Suprachoriodal Injection	7	96	7
other	Cataract subcapsular	Eye disorders	Sham Procedure	3	64	4
other	Cystoid macular oedema	Eye disorders	4mg CLS-TA Suprachoriodal Injection	0	96	0
other	Cystoid macular oedema	Eye disorders	Sham Procedure	9	64	11
other	Eye pain	Eye disorders	4mg CLS-TA Suprachoriodal Injection	14	96	18
other	Eye pain	Eye disorders	Sham Procedure	0	64	0
other	Ocular hypertension	Eye disorders	4mg CLS-TA Suprachoriodal Injection	2	96	3
other	Ocular hypertension	Eye disorders	Sham Procedure	5	64	5

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	4mg CLS-TA Suprachoriodal Injection	0	96
Total, all-cause mortality	Sham Procedure	0	64
Total, other adverse events	4mg CLS-TA Suprachoriodal Injection	42	96
Total, other adverse events	Sham Procedure	29	64
Total, serious adverse events	4mg CLS-TA Suprachoriodal Injection	3	96
Total, serious adverse events	Sham Procedure	0	64

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34322164	DERIVED	PubMed
34741564	DERIVED	PubMed
36055922	DERIVED	PubMed
36399237	DERIVED	PubMed
36787524	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
4mg CLS-TA Suprachoriodal Injection vs Sham Procedure: Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks	Trial comparisons
4mg CLS-TA Suprachoriodal Injection vs Sham Procedure: deaths from any cause	Trial comparisons
4mg CLS-TA Suprachoriodal Injection vs Sham Procedure: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02595398

GET https://conductscience.org/api/trials/v1/NCT02595398/events?page=2

API reference For AI assistants