UveitisNCT02952001
MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301
An observational study of Uveitis and Uveitis, Posterior, run by Clearside Biomedical, Inc. at 16 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Uveitis, Posterior, Uveitis, Anterior
- What is being tested?
- 4 mg CLS-TA Suprachoriodal Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 13 Dec 2017to 22 May 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Enrolled in the Parent study, CLS1001-301, through Visit 8/Month 6
- Willing and able to provide written informed consent prior to any study procedures; willing to comply with the instructions and attend all scheduled study visits
Who cannot join
- Received additional therapy for the treatment of uveitis or prohibited medication
- Require additional therapy for the treatment of uveitis or prohibited medication at the time of the Crossover visit
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States10 sites
Valley Eye Physicians and Surgeons, PC
Ayer, Massachusetts, 01432
Texas Retina Associates
Dallas, Texas, 75231
Bergstrom Eye Research
Fargo, North Dakota, 58103
Retina Group of Florida
Fort Lauderdale, Florida, 33308
Marietta Eye Clinic
Marietta, Georgia, 30060
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, 94040
Retinal Consultants of Arizona
Phoenix, Arizona, 85014
University of Pittsburgh Medical Center Eye Center
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University Casey Eye Institute
Portland, Oregon, 97239
Retina Consultants of Houston
The Woodlands, Texas, 77384
India6 sites
Sankara Eye Hospital
Coimbatore, Tamil Nadu, 641035
Sri Sankaradeva Nethralaya
Guwahati, Assam, 781028
Disha Eye Hospitals Pvt. Ltd.
Kolkata, 700120
King George's Medical University
Lucknow, Uttar Pradesh, 226003
JSS Hospital
Mysore, Karnataka, 570 004
Dr Rajendra Prasad Centre for Ophthalmic Sciences
New Delhi, 110029
About this study
Official title: MAGNOLIA: Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of CLS-TA for the Treatment of Macular Edema Associated With Non-Infectious Uveitis
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.
Read the detailed description
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.
- Being tested
- 4 mg CLS-TA Suprachoriodal Injection, Sham procedure
- Keywords
- Uveitis, UME, Posterior Uveitis, Anterior Uveitis, Intermediate Uveitis, Panuveitis, Non-infectious Uveitis, Triamcinolone, Choroid, Choroidal Injection, Suprachoroidal, Microneedle, Microinjection, Triamcinolone acetonide
- Medical subject headings
- Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 mg CLS-TA Suprachoriodal InjectionDrug
Also called Triamcinolone Acetonide
This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
Sham procedureDrug
Also called suprachoroidal sham
This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 4 mg CLS-TA Suprachoriodal Injection | |
| 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. Receives: Drug: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months following exit from Parent study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start13 Dec 2017
- Primary completion22 May 2018
- Study completion22 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clearside Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Ciulla, MD, Study director, Clearside Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952001
- Sponsor's protocol ID
- CLS1001-303
- Status last verified
- May 2021
- First submitted
- 31 Oct 2016
- Last updated
- 2 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 36787524
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAGNOLIA: Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of CLS-TA for the Treatment of Macular Edema Associated With Non-Infectious Uveitis
- ClinicalTrials.gov ID
- NCT02952001
- Acronym / sponsor ID
- CLS1001-303
- Keywords
- Uveitis, UME, Posterior Uveitis, Anterior Uveitis, Intermediate Uveitis, Panuveitis, Non-infectious Uveitis, Triamcinolone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Clearside Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Posted 7 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 mg CLS-TA Suprachoriodal Injection | – | Drug: 4 mg CLS-TA Suprachoriodal InjectionThose 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 | – | Drug: Sham procedureThose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Enrolled in the Parent study, CLS1001-301, through Visit 8/Month 6
- Willing and able to provide written informed consent prior to any study procedures; willing to comply with the instructions and attend all scheduled study visits
Key exclusion criteria (2 listed)
- Received additional therapy for the treatment of uveitis or prohibited medication
- Require additional therapy for the treatment of uveitis or prohibited medication at the time of the Crossover visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 mg CLS-TA Suprachoriodal InjectionAlso: Triamcinolone AcetonideThis drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study. | Drug | 4 mg CLS-TA Suprachoriodal Injection |
| Sham procedureAlso: suprachoroidal shamThis drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study. | Drug | Sham procedure |
Primary outcome
Time to Additional Therapy for Uveitis
Time frame: 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year
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).
3 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Time frame: 6 months following exit from Parent study
Mean Change From Baseline in Central Subfield Thickness
Time frame: 6 months following exit from Parent study
Mean Change From Baseline in Best Corrected Visual Acuity
Time frame: 6 months following exit from Parent study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36787524Yeh 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Ciulla, MD study director
Clearside Biomedical, Inc.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis and Uveitis, Posterior, run by Clearside Biomedical, Inc. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Additional Therapy for Uveitis (time frame: 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02952001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.