An observational study in Uveitis, Uveitis, Posterior and Uveitis, Anterior, sponsored by Clearside Biomedical, Inc.. Completed at 16 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-02.
Sponsored by Clearside Biomedical, Inc. · Observational
This study is a non-interventional, observational extension of the Parent study, CLS1001-301 (NCT02595398). The purpose of this study is to characterize the continued clinical benefit(s) regarding safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide injectable suspension, for the treatment of macular edema associated with non-infectious uveitis.
This is a non-interventional, observation extension study of up to 6 months for subjects completing the Parent study, CLS1001-301 (NCT02595398). The Parent study is a Phase 3, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.
The design of the Extension study includes 4 clinic visits over a maximum of 24 weeks. Subject eligibility will be established at Visit 1 during the crossover day from the Parent study to the extension study (Day 0). Follow-up visits will be conducted every 6 weeks up to 24 weeks (Visit 4). At Visit 4, subjects will have a final evaluation conducted 24 weeks following study entry (48 weeks from Parent study randomization).
This study was initiated prior to the completion of the parent study, therefore treatment assignment was masked prior to study entry.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 33 is below the median of 107 across 104 observational studies indexed under Uveitis.
Browse Uveitis studies →Clearside Biomedical, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will include approximately 30 adult subjects that successfully complete the Parent study without requiring additional therapy to treat symptoms for uveitis as defined by the protocol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation without receiving additional therapy. No study drug was administered during this study.
Drug: 4 mg CLS-TA Suprachoriodal Injection
Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation without receiving additional therapy. No study drug was administered during this study.
Drug: Sham procedure
This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
Also known as: Triamcinolone Acetonide
This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
Also known as: suprachoroidal sham
Time to Additional Therapy for Uveitis
This time to event outcome was calculated as the number of days between the date of initiation of additional therapy for uveitis and the date of first treatment in the Parent study CLS1001-301 (NCT02595398).
Time frame: 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Number of participants with treatment emergent adverse events and serious adverse events reported during the extension study.
Time frame: 6 months following exit from Parent study
Mean Change From Baseline 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.
Time frame: 6 months following exit from Parent study
Mean Change From Baseline in Best Corrected Visual Acuity
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.
Time frame: 6 months following exit from Parent study
Subjects enrolled into the Parent study CLS1001-301 (NCT02595398), and who completed the Parent study without receiving additional therapy for uveitis were eligible for enrollment into this non-interventional observation extension study. The Parent study was still masked when subjects started enrolling into this extension study, therefore, treatment assignment was unknown at study entry and during the study.
| Milestone | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| Started | 28 | 5 |
| Completed | 14 | 2 |
| Not completed | 14 | 3 |
| Withdrew: Adverse event | 3 | 0 |
| Withdrew: Prohibited therapy | 10 | 3 |
| Withdrew: Due to posterior capsular opacity | 1 | 0 |
This time to event outcome was calculated as the number of days between the date of initiation of additional therapy for uveitis and the date of first treatment in the Parent study CLS1001-301 (NCT02595398).
| days | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| Time to Additional Therapy for Uveitis | 344.0 (282.0 to NA) | 332.0 (280.0 to NA) |
Number of participants with treatment emergent adverse events and serious adverse events reported during the extension study.
| Participants | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| Treatment-emergent adverse events | 16 | 3 |
| Serious adverse events | 1 | 0 |
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.
| microns | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| Mean Change From Baseline in Central Subfield Thickness | -174.5 ± 145.70 | 19.5 ± 0.71 |
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.
| letters | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity | 12.1 ± 13.00 | 14.0 ± 15.56 |
Collected over 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 4 mg CLS-TA Suprachoriodal Injection | 0/28 (0%) | 1/28 (3.6%) | 16/28 (57.1%) |
| Sham Procedure | 0/5 (0%) | 0/5 (0%) | 3/5 (60%) |
| Event | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| Oesophageal achalasiaGastrointestinal disorders | 1/28 | 0/5 |
| PneumoniaInfections and infestations | 1/28 | 0/5 |
| Septic shockInfections and infestations | 1/28 | 0/5 |
| Acute kidney injuryRenal and urinary disorders | 1/28 | 0/5 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/28 | 0/5 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 1/28 | 0/5 |
| Event | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure |
|---|---|---|
| Infection parasiticInfections and infestations | 0/28 | 1/5 |
| Eosinophil count increasedInvestigations | 0/28 | 1/5 |
| Cataract corticalEye disorders | 0/28 | 1/5 |
| Macular fibrosisEye disorders | 0/28 | 1/5 |
| Macular oedemaEye disorders | 1/28 | 1/5 |
| UveitisEye disorders | 3/28 | 1/5 |
| Cataract corticalEye disorders | 0/28 | 1/5 |
| Cataract subcapsularEye disorders | 5/28 | 0/5 |
| Intraocular pressure increasedInvestigations | 3/28 | 0/5 |
| CataractEye disorders | 2/28 | 0/5 |
The Safety population included all enrolled subjects who successfully completed the enrollment visit of the extension study.
| Age, Categorical(Participants) | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 4 | 28 |
| >=65 years | 4 | 1 | 5 |
| Age, Continuous(years) | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| Mean | 48.57 ± 15.039 | 51.20 ± 15.818 | 48.97 ± 14.934 |
| Sex: Female, Male(Participants) | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| Female | 14 | 1 | 15 |
| Male | 14 | 4 | 18 |
| Ethnicity (NIH/OMB)(Participants) | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 28 | 5 | 33 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 20 | 2 | 22 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 7 | 2 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| United States | 8 | 3 | 11 |
| India | 20 | 2 | 22 |
| Type of Uveitis(Participants) | 4 mg CLS-TA Suprachoriodal Injection | Sham Procedure | Total |
|---|---|---|---|
| Anterior uveitis | 10 | 1 | 11 |
| Intermediate uveitis | 9 | 0 | 9 |
| Posterior uveitis | 11 | 1 | 12 |
| Panuveitis | 4 | 3 | 7 |
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Clearside Biomedical, Inc.