Trial · NCT03203447
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO
NCT03203447, Phase 3, Terminated, Clearside Biomedical, Inc.; results first posted 2021-04-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO. Trials, record NCT03203447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03203447
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO
- NCT number
- NCT03203447
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 325 participants, actual
- Lead sponsor
- Clearside Biomedical, Inc.
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Interventions
- suprachoroidal CLS-TA, suprachoroidal sham, Lucentis or Avastin
- First posted
- 2017-06-29
- Last updated
- 2021-04-23
- Results first posted
- 2021-04-23
- Limitations and caveats
Due to the early termination of the trial by sponsor, 325 of the planned 460 were enrolled. 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 patients. Values for missing data were imputed using last observation carried forward. | 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. Values for missing data were not imputed. | 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. Values for missing data were not imputed. | 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 | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) | Active | 64 | Participants | ||
| Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) | Control | 76 | Participants | ||
| Mean Change From Baseline in Best Corrected Visual Acuity | Active | 13.8 | Standard Error 1.96 | letters | |
| Mean Change From Baseline in Best Corrected Visual Acuity | Control | 20.7 | Standard Error 1.91 | letters | |
| Mean Change From Baseline in Central Subfield Thickness | Active | -353.6 | Standard Error 19.60 | microns | |
| Mean Change From Baseline in Central Subfield Thickness | Control | -374.7 | Standard Error 19.12 | microns |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active | 162 | |
| Overall Study | STARTED | Control | 163 | |
| Overall Study | COMPLETED | Active | 0 | |
| Overall Study | COMPLETED | Control | 0 | |
| Overall Study | NOT COMPLETED | Active | 162 | |
| Overall Study | NOT COMPLETED | Control | 163 |
Source ClinicalTrials.gov
Adverse events18
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 | Intraocular pressure increased | Investigations | Active | 11 | 160 | 14 |
| other | Intraocular pressure increased | Investigations | Control | 1 | 162 | 1 |
| serious | Cardiac failure congestive | Cardiac disorders | Active | 1 | 160 | 1 |
| serious | Cardiac failure congestive | Cardiac disorders | Control | 0 | 162 | 0 |
| serious | Abdominal pain upper | Gastrointestinal disorders | Active | 0 | 160 | 0 |
| serious | Abdominal pain upper | Gastrointestinal disorders | Control | 1 | 162 | 1 |
| serious | Urinary tract infection | Infections and infestations | Active | 0 | 160 | 0 |
| serious | Urinary tract infection | Infections and infestations | Control | 1 | 162 | 1 |
| serious | Hyperglycaemia | Metabolism and nutrition disorders | Active | 0 | 160 | 0 |
| serious | Hyperglycaemia | Metabolism and nutrition disorders | Control | 1 | 162 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active | 0 | 160 |
| Total, all-cause mortality | Control | 0 | 162 |
| Total, other adverse events | Active | 11 | 160 |
| Total, other adverse events | Control | 1 | 162 |
| Total, serious adverse events | Active | 1 | 160 |
| Total, serious adverse events | Control | 3 | 162 |
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.
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/NCT03203447
GET https://conductscience.org/api/trials/v1/NCT03203447/registered