Trial · NCT02980874

Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

NCT02980874, Phase 3, Terminated, Clearside Biomedical, Inc.; results first posted 2021-04-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO. Trials, record NCT02980874. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02980874

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Trial

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

Title: Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
NCT number: NCT02980874
Status: Terminated
Phases: Phase 3
Enrollment: 460 participants, actual
Lead sponsor: Clearside Biomedical, Inc.
Conditions: Macular Edema, Retinal Vein Occlusion
Interventions: suprachoroidal CLS-TA, suprachoroidal sham, IVT aflibercept
First posted: 2016-12-02
Last updated: 2021-04-14
Results first posted: 2021-04-14
Limitations and caveats: Due to the early termination of the trial by sponsor all planned study visits were not completed by all treated subjects; therefore, all planned data was not collected.

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)	2 months	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.
Secondary	Mean Change From Baseline in Best Corrected Visual Acuity	6 months	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.
Secondary	Mean Change From Baseline in Central Subfield Thickness	6 months	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.

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	Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)	2 months	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 Best Corrected Visual Acuity	6 months	The Intent-to-treat population included all randomized subjects who received at least one study treatment.	Letters	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Central Subfield Thickness	6 months	The Intent-to-treat population included all randomized subjects who received at least one study treatment.	Microns	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)	Active	114		Participants
Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)	Control	127		Participants
Mean Change From Baseline in Best Corrected Visual Acuity	Active	15.5	Standard Error 0.85	Letters
Mean Change From Baseline in Best Corrected Visual Acuity	Control	20.5	Standard Error 0.85	Letters
Mean Change From Baseline in Central Subfield Thickness	Active	-354.3	Standard Error 8.01	Microns
Mean Change From Baseline in Central Subfield Thickness	Control	-416.2	Standard Error 8.05	Microns

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Active	231
Overall Study	STARTED	Control	229
Overall Study	COMPLETED	Active	128
Overall Study	COMPLETED	Control	127
Overall Study	NOT COMPLETED	Active	103
Overall Study	NOT COMPLETED	Control	102

Source ClinicalTrials.gov

Adverse events156

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	Cataract	Eye disorders	Active	21	231	29
other	Cataract	Eye disorders	Control	9	229	12
other	Cataract subcapsular	Eye disorders	Active	20	231	22
other	Cataract subcapsular	Eye disorders	Control	3	229	3
other	Conjunctival haemorrhage	Eye disorders	Active	42	231	65
other	Conjunctival haemorrhage	Eye disorders	Control	28	229	31
other	Eye pain	Eye disorders	Active	20	231	24
other	Eye pain	Eye disorders	Control	11	229	11
other	Macular oedema	Eye disorders	Active	8	231	11
other	Macular oedema	Eye disorders	Control	13	229	16

1 to 10 of 156Source ClinicalTrials.gov

See all 156 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active	0	231
Total, all-cause mortality	Control	0	229
Total, other adverse events	Active	128	231
Total, other adverse events	Control	83	229
Total, serious adverse events	Active	25	231
Total, serious adverse events	Control	28	229

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
Active vs Control: Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)	Trial comparisons
Active vs Control: deaths from any cause	Trial comparisons
Active vs Control: 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/NCT02980874

GET https://conductscience.org/api/trials/v1/NCT02980874/events?page=2

API reference For AI assistants