UveitisPhase 3PEACHTREENCT02595398
Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis
A Phase 3 study testing 4mg CLS-TA Suprachoriodal Injection in people with Uveitis and Uveitis, Posterior, run by Clearside Biomedical, Inc. at 64 sites in 3 countries.
Trial summary
The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis. 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?
- 4mg 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
- 160 participants
- Where
- 64 sitesin 3 countries
- Study dates
- 17 Nov 2015to 18 Jan 2018
- Phase
- Phase 3
- 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
Who may be able to join
- Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)
- Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness ≥ 300 microns)
- Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 letters read (20/40 Snellen equivalent), in the study eye
Who cannot join
- Any active ocular disease or infection in the study eye other than uveitis
- Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; subjects are not excluded if IOP ≤ 22 mmHg with no more than 2 IOP lowering medications.
- Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
- Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.
Trial locations and contacts
64 sites in 3 countries.
64 sites in 3 countries
United States40 sites
Emory Eye Center Emory University
Atlanta, Georgia, 30322
University of Colorado
Aurora, Colorado, 80045
Austin Retina Associates
Austin, Texas, 78705
Valley Eye Physicians and Surgeons, PC
Ayer, Massachusetts, 01432
California Retina Consultants
Bakersfield, California, 93309
Elman Retina Group, PA
Baltimore, Maryland, 21237
Vitreoretinal Associates of Washington
Bellevue, Washington, 98004
Charlotte Eye Ear Nose and Throat Associates, PA
Belmont, North Carolina, 28012
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
The Retina Group of Washington
Chevy Chase, Maryland, 20815
Northwestern University
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60612
Texas Retina Associates
Dallas, Texas, 75231
Bergstrom Eye Research
Fargo, North Dakota, 58103
Retina Group of Florida
Fort Lauderdale, Florida, 33308
Colorado Retina Associates
Golden, Colorado, 80401
Innovative Clinical Research
Greenville, South Carolina, 29605
Retina Consultants of Houston
Houston, Texas, 77030
Discover Vision Centers
Independence, Missouri, 64055
Midwest Eye Retina Practicing at Midwest Eye Institute
Indianapolis, Indiana, 46290
Center for Retina and Macular Disease
Lakeland, Florida, 33805
USC Eye Institute
Los Angeles, California, 90033
Marietta Eye Clinic
Marietta, Georgia, 30060
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, 94040
Weill Cornell Medical College
New York, New York, 10021
Virginia Eye Consultants
Norfolk, Virginia, 23502
Illinois Retina Associates, S.C.
Oak Park, Illinois, 60304
Metropolitan Eye Research & Surgery Institute
Palisades Park, New Jersey, 07650
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
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
Foresight Studies, LLC
San Antonio, Texas, 78233
Orange County Retina Medical Group
Santa Ana, California, 92705
Retina Consultants PLLC
Slingerlands, New York, 12159
Retina Consultants of Houston
The Woodlands, Texas, 77384
Retina Centers, PC
Tucson, Arizona, 85704
Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution
Waltham, Massachusetts, 01741
Wake Forest Baptist Health Eye Center
Winston-Salem, North Carolina, 27103
India16 sites
M&J Western Regional Institute of Ophthalmology
Ahmedabad, Gujarat
Sankara Nethralaya
Chennai, Tamil Nadu
Sankara Eye Hospital
Coimbatore, Tamil Nadu
Sri Sankaradeva Nethralaya
Guwahati, Assam
L V Prasad Eye Hospital
Hyderabad, Andhra Pradesh
Calcutta Medical Research Institute
Kolkata, 700027
Disha Eye Hospital
Kolkata
King George's Medical University
Lucknow, Uttar Pradesh
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh
TN Medical College and BYL Nair Hospital
Mumbai, Maharashtra
JSS Hospital
Mysore, Karnataka
Dr Rajendra Prasad Centre for Ophthalmic Sciences
New Delhi, 110029
Dr. Shroff's Charity Eye Hospital
New Delhi
Icare Eye Hospital & PG Institute
Noida, Uttar Pradesh
PBMA's H V Desai Eye Hospital
Pune, Maharashtra
Regional Institute of Ophthalmology
Thiruvananthapuram, Kerala
Israel8 sites
Soroka Medical Center
Beersheba, 85025
Bnai Zion Medical Center
Haifa, 3104802
Rambam Health Corp
Haifa, 3109601
Hadassah-Hebrew University Medical Center
Jerusalem, 91120
Rabin Medical Center
Petah Tikva, 4941492
Sheba Medical Center
Ramat Gan, 52621
Kaplan Medical Center
Rehovot, 76100
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
About this study
Official title: A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects With Macular Edema Associated With Non-infectious Uveitis
The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.
Read the detailed description
This is a Phase 3, randomized, masked, sham-controlled, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham injection procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.
Qualified subjects will be randomized to receive two suprachoroidal injections of CLS-TA administered to the study eye or two sham injection procedures administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).
- Being tested
- 4mg 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.
4mg CLS-TA Suprachoriodal InjectionDrug
Also called Triamcinolone Acetonide
CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
Sham ProcedureDrug
Also called suprachoroidal sham
Sham procedure administered at 2 timepoints
| Study group | Role | What they receive |
|---|---|---|
| 4mg CLS-TA Suprachoriodal Injection | Experimental | Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA Receives: Drug: 4mg CLS-TA Suprachoriodal Injection |
| Sham Procedure | Sham comparator | Matching suprachoroidal syringe with sham procedure Receives: Drug: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
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.
Measured: Baseline, 24 weeks
Secondary outcomes (2)
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. Only images that were gradable by the central reading center were included in the analysis.
Measured: Baseline, 24 weeks
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of subjects with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported between the first dose of study drug and study exit.
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start17 Nov 2015
- Primary completion18 Jan 2018
- Study completion18 Jan 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 (5)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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clearside Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Cuilla, MD, MBA, Study director, Clearside Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595398
- Sponsor's protocol ID
- CLS1001-301
- Acronym
- PEACHTREE
- Status last verified
- May 2021
- First submitted
- 28 Oct 2015
- Last updated
- 28 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 36787524Yeh S, Henry CR, Kapik B, Ciulla TA. Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies. Ophthalmol Ther. 2023 Feb;12(1):577-591. doi: 10.1007/s40123-022-00603-x. Epub 2022 Nov 18.
PubMed 36399237Bhattacharyya S, Hariprasad SM, Albini TA, Dutta SK, John D, Padula WV, Harrison D, Joseph G. Suprachoroidal Injection of Triamcinolone Acetonide Injectable Suspension for the Treatment of Macular Edema Associated With Uveitis in the United States: A Cost-Effectiveness Analysis. Value Health. 2022 Oct;25(10):1705-1716. doi: 10.1016/j.jval.2022.07.008. Epub 2022 Aug 31.
PubMed 36055922Singer MA, Merrill P, Yeh S, Hall C, Kapik B, Ciulla TA. Suprachoroidal triamcinolone acetonide versus rescue therapies for the treatment of uveitic macular oedema: A post hoc analysis of PEACHTREE. Clin Exp Ophthalmol. 2022 Jan;50(1):23-30. doi: 10.1111/ceo.14024. Epub 2021 Dec 27.
PubMed 34741564Price KW, Albini TA, Yeh S. Suprachoroidal Injection of Triamcinolone- Review of a Novel Treatment for Macular Edema Caused by Noninfectious Uveitis. US Ophthalmic Rev. 2020 Fall;13(2):76-79. doi: 10.17925/usor.2020.13.2.76. Epub 2020 Dec 23.
PubMed 34322164
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects With Macular Edema Associated With Non-infectious Uveitis
- ClinicalTrials.gov ID
- NCT02595398
- Acronym / sponsor ID
- PEACHTREE / CLS1001-301
- Keywords
- Uveitis, UME, Posterior Uveitis, Anterior Uveitis, Intermediate Uveitis, Panuveitis, Non-infectious Uveitis, Triamcinolone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Clearside Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Posted 28 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.
Detailed description
This is a Phase 3, randomized, masked, sham-controlled, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham injection procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.
Qualified subjects will be randomized to receive two suprachoroidal injections of CLS-TA administered to the study eye or two sham injection procedures administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4mg CLS-TA Suprachoriodal Injection | Experimental | Drug: 4mg CLS-TA Suprachoriodal InjectionSuprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA |
| Sham Procedure | Sham comparator | Drug: Sham ProcedureMatching suprachoroidal syringe with sham procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)
- Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness ≥ 300 microns)
- Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 letters read (20/40 Snellen equivalent), in the study eye
Key exclusion criteria (4 listed)
- Any active ocular disease or infection in the study eye other than uveitis
- Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; subjects are not excluded if IOP ≤ 22 mmHg with no more than 2 IOP lowering medications.
- Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
- Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.
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 |
|---|---|---|
| 4mg CLS-TA Suprachoriodal InjectionAlso: Triamcinolone AcetonideCLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints | Drug | 4mg CLS-TA Suprachoriodal Injection |
| Sham ProcedureAlso: suprachoroidal shamSham procedure administered at 2 timepoints | Drug | Sham Procedure |
Primary outcome
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
Time frame: Baseline, 24 weeks
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.
2 secondary outcomes
Mean Change From Baseline in Central Subfield Thickness
Time frame: Baseline, 24 weeks
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 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.
- Derived from this study: PubMed 36399237Yeh S, Henry CR, Kapik B, Ciulla TA. Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies. Ophthalmol Ther. 2023 Feb;12(1):577-591. doi: 10.1007/s40123-022-00603-x. Epub 2022 Nov 18.
- Derived from this study: PubMed 36055922Bhattacharyya S, Hariprasad SM, Albini TA, Dutta SK, John D, Padula WV, Harrison D, Joseph G. Suprachoroidal Injection of Triamcinolone Acetonide Injectable Suspension for the Treatment of Macular Edema Associated With Uveitis in the United States: A Cost-Effectiveness Analysis. Value Health. 2022 Oct;25(10):1705-1716. doi: 10.1016/j.jval.2022.07.008. Epub 2022 Aug 31.
- Derived from this study: PubMed 34741564Singer MA, Merrill P, Yeh S, Hall C, Kapik B, Ciulla TA. Suprachoroidal triamcinolone acetonide versus rescue therapies for the treatment of uveitic macular oedema: A post hoc analysis of PEACHTREE. Clin Exp Ophthalmol. 2022 Jan;50(1):23-30. doi: 10.1111/ceo.14024. Epub 2021 Dec 27.
- Derived from this study: PubMed 34322164Price KW, Albini TA, Yeh S. Suprachoroidal Injection of Triamcinolone- Review of a Novel Treatment for Macular Edema Caused by Noninfectious Uveitis. US Ophthalmic Rev. 2020 Fall;13(2):76-79. doi: 10.17925/usor.2020.13.2.76. Epub 2020 Dec 23.
- Individual participant dataSharing planned: No
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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 Cuilla, MD, MBA study director
Clearside Biomedical, Inc.
64 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 4mg CLS-TA Suprachoriodal Injection in people with Uveitis and Uveitis, Posterior, run by Clearside Biomedical, Inc. at 64 sites in 3 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 3 inclusion and 4 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 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, India, Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 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?
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks (time frame: Baseline, 24 weeks). 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 NCT02595398, which also lists 5 linked publications.
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 28 May 2021.