Comparison · NCT02595398-846da4e4
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
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 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, record NCT02595398-846da4e4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02595398-846da4e4
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.469 | 0.372 | 0.568 | wilson | |
| Risk in group 2 | 0.156 | 0.0871 | 0.264 | wilson | |
| Risk difference, group 1 minus group 2 | 0.313 | 0.168 | 0.433 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3 | 1.63 | 5.51 | log | |
| Odds ratio, group 1 over group 2 | 4.76 | 2.17 | 10.4 | log | |
| Number needed to treat, for one more participant with the outcome on 4mg CLS-TA Suprachoriodal Injection than on Sham Procedure | 3.2 | 2.31 | 5.97 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: sham.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 4mg CLS-TA Suprachoriodal Injection | Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA~4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints | 45 | 96 | OG000 |
| Group 2 | Sham Procedure | Matching suprachoroidal syringe with sham procedure~Sham Procedure: Sham procedure administered at 2 timepoints | 10 | 64 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
- Description
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.
- Time frame
- Baseline, 24 weeks
- Population
- The Intent-to-treat population included all randomized subjects who received at least one study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis
- NCT number
- NCT02595398
- Phases
- PHASE3
- Conditions
- Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis
- Interventions
- 4mg CLS-TA Suprachoriodal Injection, Sham Procedure
- Lead sponsor
- Clearside Biomedical, Inc.
- Results first posted
- 2021-04-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02595398?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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