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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mg CLS-TA Suprachoriodal Injection | 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. |
| |
| Sham procedure | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 mg CLS-TA Suprachoriodal Injection | Drug | This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months following exit from Parent study |
| Mean Change From Baseline in Central Subfield Thickness |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Ciulla, MD | Clearside Biomedical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona | Phoenix | Arizona | 85014 | United States | ||
| Northern California Retina Vitreous Associates Medical Group, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36787524 | Derived | Yeh S, Ciulla T. Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety. Am J Manag Care. 2023 Feb;29(2 Suppl):S19-S28. doi: 10.37765/ajmc.2023.89324. |
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Subjects enrolled into this non-interventional observational extension study successfully completed the Parent study CLS1001-301 (NCT02595398) without requiring additional therapy for uveitis. In the Parent study, subjects were randomized 3:2 to either 4 mg CLS-TA or a sham procedure in a masked fashion. Eligible and consenting subjects from selected sites were enrolled into the non-interventional extension 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 4 mg CLS-TA Suprachoriodal Injection | Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study. 4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2016 |
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|
| Sham procedure | Drug | This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study. |
|
|
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. |
| 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. | 6 months following exit from Parent study |
| Mountain View |
| California |
| 94040 |
| United States |
| Retina Group of Florida | Fort Lauderdale | Florida | 33308 | United States |
| Marietta Eye Clinic | Marietta | Georgia | 30060 | United States |
| Valley Eye Physicians and Surgeons, PC | Ayer | Massachusetts | 01432 | United States |
| Bergstrom Eye Research | Fargo | North Dakota | 58103 | United States |
| Oregon Health & Science University Casey Eye Institute | Portland | Oregon | 97239 | United States |
| University of Pittsburgh Medical Center Eye Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| Sri Sankaradeva Nethralaya | Guwahati | Assam | 781028 | India |
| JSS Hospital | Mysore | Karnataka | 570 004 | India |
| Sankara Eye Hospital | Coimbatore | Tamil Nadu | 641035 | India |
| King George's Medical University | Lucknow | Uttar Pradesh | 226003 | India |
| Disha Eye Hospitals Pvt. Ltd. | Kolkata | 700120 | India |
| Dr Rajendra Prasad Centre for Ophthalmic Sciences | New Delhi | 110029 | India |
| FG001 | Sham Procedure | Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study. Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study. |
| COMPLETED |
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| NOT COMPLETED |
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The Safety population included all enrolled subjects who successfully completed the enrollment visit of the extension study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 mg CLS-TA Suprachoriodal Injection | Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study. 4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study. |
| BG001 | Sham Procedure | Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study. Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age of subjects in years relative to the date of the Screening visit from the Parent study CLS1001-301 (NCT02595398). | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | Age of subjects in years relative to the date of the Screening visit from the Parent study CLS1001-301 (NCT02595398). | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Type of Uveitis | Location of inflammation in the study eye, including anterior (anterior chamber), intermediate (vitreous), posterior (retina or choroid) and panuveitis. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The Safety population included all enrolled subjects who successfully completed the enrollment visit of the extension study. | Posted | Median | 95% Confidence Interval | days | 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety population included all enrolled subjects who successfully completed the enrollment visit of the extension study. | Posted | Count of Participants | Participants | 6 months following exit from Parent study |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety population included all enrolled subjects who successfully completed the enrollment visit of the extension study. Results include those subjects with gradable images at follow-up week 24. Values for missing data were not imputed. | Posted | Mean | Standard Deviation | microns | 6 months following exit from Parent study |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety population included all enrolled subjects who successfully completed the enrollment visit of the extension study. Results include those subjects with non-missing BCVA values at follow-up week 24. Values for missing data were not imputed. | Posted | Mean | Standard Deviation | letters | 6 months following exit from Parent study |
|
6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.
Treatment-emergent adverse events and SAEs initiating or worsening in severity relative to the date of enrollment into the extension study (day 0) were summarized.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4 mg CLS-TA Suprachoriodal Injection | Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study. 4 mg CLS-TA Suprachoriodal Injection: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study. | 0 | 28 | 1 | 28 | 16 | 28 |
| EG001 | Sham Procedure | Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation in the Parent study without receiving additional therapy. No study drug was administered during this study. Sham procedure: This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study. | 0 | 5 | 0 | 5 | 3 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection parasitic | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (18.1) | Non-systematic Assessment | #Study eye |
|
| Cataract cortical | Eye disorders | MedDRA (18.1) | Non-systematic Assessment | #Study eye |
|
| Cataract subcapsular | Eye disorders | MedDRA (18.1) | Non-systematic Assessment | #Study eye |
|
| Macular fibrosis | Eye disorders | MedDRA (18.1) | Non-systematic Assessment | #Study eye |
|
| Macular oedema | Eye disorders | MedDRA (18.1) | Non-systematic Assessment | #Study eye |
|
| Uveitis | Eye disorders | MedDRA (18.1) | Non-systematic Assessment | #Study eye |
|
| Intraocular pressure increased | Investigations | MedDRA (18.1) | Non-systematic Assessment | #Study eye |
|
| Cataract cortical | Eye disorders | MedDRA (18.1) | Non-systematic Assessment | #Fellow eye |
|
| Eye pain | Eye disorders | MedDRA (18.1) | Non-systematic Assessment | #Fellow eye |
|
| Uveitis | Eye disorders | MedDRA (18.1) | Non-systematic Assessment | #Fellow eye |
|
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 enrolled into this extension study, therefore, treatment assignment was unknown at study entry and remained masked until completion of the Parent study which occurred prior to the completion of this study.
The institution and investigators participating in this trial shall have no right to publish or present the results of this study without the prior written consent of Clearside Biomedical.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Ciulla, MD MBA | Clearside Biomedical, Inc. | (678) 392-2318 | thomas.ciulla@clearsidebio.com |
| Mar 16, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| D015866 | Uveitis, Posterior |
| D014606 | Uveitis, Anterior |
| D015867 | Uveitis, Intermediate |
| D015864 | Panuveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| India |
|
| Intermediate uveitis |
|
| Posterior uveitis |
|
| Panuveitis |
|
| Units | Counts |
|---|---|
| Participants |
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