18 and older, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse EventsPrimary· Over 6 months of follow-up
Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up
Number of participants with treatment emergent adverse events
Group
Value
95% CI
TX Naïve Arm
8
Previous TX Arm
9
Number of participants with serious adverse events
Group
Value
95% CI
TX Naïve Arm
0
Previous TX Arm
0
Mean Change From Baseline in Intraocular PressureSecondary· Baseline and 6 months
Baseline and change from baseline at 6 months in intraocular pressure as measured by applanation tonometry
Baseline
Group
Value
95% CI
TX Naïve Arm
14.2
± 3.52
Previous TX Arm
13.3
± 2.50
Month 6
Group
Value
95% CI
TX Naïve Arm
-0.3
± 2.41
Previous TX Arm
2.8
± 7.89
Mean Change From Baseline in Central Subfield ThicknessSecondary· Baseline and 6 months
Baseline and change from baseline at 6 months in central subfield thickness. 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.
Baseline
Group
Value
95% CI
Previous TX Arm
421.6
± 94.33
TX Naïve Arm
472.7
± 109.46
Month 6
Group
Value
95% CI
Previous TX Arm
-90.9
± 62.48
TX Naïve Arm
-119.6
± 65.48
Best Corrected Visual AcuitySecondary· Baseline and 6 months
Baseline and Change from baseline at 6 months in best corrected visual acuity before and after treatment 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 as the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.
Baseline
Group
Value
95% CI
TX Naïve Arm
67.2
± 11.66
Previous TX Arm
67.2
± 8.95
Month 6
Group
Value
95% CI
TX Naïve Arm
8.5
± 11.96
Previous TX Arm
1.1
± 11.94
CLS-TA InjectionsSecondary· 2 to 6 months following initial treatment with study drug
After the initial treatment with CLS-TA, with or without intravitreal aflibercept, at Baseline, retreatment with CLS-TA was allowed in either treatment group from Month 2 through Month 6 if pre-defined retreatment criteria were met. Number of patients receiving 0, 1, 2, 3, 4 or 5 retreatments with CLS-TA.
0 additional injections
Group
Value
95% CI
TX Naïve Arm
4
Previous TX Arm
1
1 additional injection
Group
Value
95% CI
TX Naïve Arm
2
Previous TX Arm
3
2 additional injections
Group
Value
95% CI
TX Naïve Arm
0
Previous TX Arm
2
3 additional injections
Group
Value
95% CI
TX Naïve Arm
2
Previous TX Arm
0
4 additional injections
Group
Value
95% CI
TX Naïve Arm
2
Previous TX Arm
4
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is designed to demonstrate the safety and tolerability of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema associated with diabetes mellitus.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Other Clearside Biomedical, Inc. trials
Trials by the same sponsor.
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· Phase 2
· completed
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· completed
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· Phase 1, PHASE2
· completed
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· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Clearside Biomedical, Inc.
Last refreshed: 13 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02949024.