Uveitis Clinical Trial
— PEACHTREEOfficial 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
Verified date | May 2021 |
Source | Clearside Biomedical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | January 18, 2018 |
Est. primary completion date | January 18, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
India | M&J Western Regional Institute of Ophthalmology | Ahmedabad | Gujarat |
India | Sankara Nethralaya | Chennai | Tamil Nadu |
India | Sankara Eye Hospital | Coimbatore | Tamil Nadu |
India | Sri Sankaradeva Nethralaya | Guwahati | Assam |
India | L V Prasad Eye Hospital | Hyderabad | Andhra Pradesh |
India | Calcutta Medical Research Institute | Kolkata | |
India | Disha Eye Hospital | Kolkata | |
India | King George's Medical University | Lucknow | Uttar Pradesh |
India | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Lucknow | Uttar Pradesh |
India | TN Medical College and BYL Nair Hospital | Mumbai | Maharashtra |
India | JSS Hospital | Mysore | Karnataka |
India | Dr Rajendra Prasad Centre for Ophthalmic Sciences | New Delhi | |
India | Dr. Shroff's Charity Eye Hospital | New Delhi | |
India | Icare Eye Hospital & PG Institute | Noida | Uttar Pradesh |
India | PBMA's H V Desai Eye Hospital | Pune | Maharashtra |
India | Regional Institute of Ophthalmology | Thiruvananthapuram | Kerala |
Israel | Soroka Medical Center | Beer Sheva | |
Israel | Bnai Zion Medical Center | Haifa | |
Israel | Rambam Health Corp | Haifa | |
Israel | Hadassah-Hebrew University Medical Center | Jerusalem | |
Israel | Rabin Medical Center | Petah Tikva | |
Israel | Sheba Medical Center | Ramat Gan | |
Israel | Kaplan Medical Center | Rehovot | |
Israel | Tel-Aviv Sourasky Medical Center | Tel Aviv | |
United States | Emory Eye Center Emory University | Atlanta | Georgia |
United States | University of Colorado | Aurora | Colorado |
United States | Austin Retina Associates | Austin | Texas |
United States | Valley Eye Physicians and Surgeons, PC | Ayer | Massachusetts |
United States | California Retina Consultants | Bakersfield | California |
United States | Elman Retina Group, PA | Baltimore | Maryland |
United States | Vitreoretinal Associates of Washington | Bellevue | Washington |
United States | Charlotte Eye Ear Nose and Throat Associates, PA | Belmont | North Carolina |
United States | Retina-Vitreous Associates Medical Group | Beverly Hills | California |
United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
United States | The Retina Group of Washington | Chevy Chase | Maryland |
United States | Northwestern University | Chicago | Illinois |
United States | University of Illinois at Chicago | Chicago | Illinois |
United States | Texas Retina Associates | Dallas | Texas |
United States | Bergstrom Eye Research | Fargo | North Dakota |
United States | Retina Group of Florida | Fort Lauderdale | Florida |
United States | Colorado Retina Associates | Golden | Colorado |
United States | Innovative Clinical Research | Greenville | South Carolina |
United States | Retina Consultants of Houston | Houston | Texas |
United States | Discover Vision Centers | Independence | Missouri |
United States | Midwest Eye Retina Practicing at Midwest Eye Institute | Indianapolis | Indiana |
United States | Center for Retina and Macular Disease | Lakeland | Florida |
United States | USC Eye Institute | Los Angeles | California |
United States | Marietta Eye Clinic | Marietta | Georgia |
United States | Northern California Retina Vitreous Associates Medical Group, Inc. | Mountain View | California |
United States | Weill Cornell Medical College | New York | New York |
United States | Virginia Eye Consultants | Norfolk | Virginia |
United States | Illinois Retina Associates, S.C. | Oak Park | Illinois |
United States | Metropolitan Eye Research & Surgery Institute | Palisades Park | New Jersey |
United States | Mid Atlantic Retina | Philadelphia | Pennsylvania |
United States | Retinal Consultants of Arizona | Phoenix | Arizona |
United States | University of Pittsburgh Medical Center Eye Center | Pittsburgh | Pennsylvania |
United States | Oregon Health & Science University Casey Eye Institute | Portland | Oregon |
United States | Foresight Studies, LLC | San Antonio | Texas |
United States | Orange County Retina Medical Group | Santa Ana | California |
United States | Retina Consultants PLLC | Slingerlands | New York |
United States | Retina Consultants of Houston | The Woodlands | Texas |
United States | Retina Centers, PC | Tucson | Arizona |
United States | Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution | Waltham | Massachusetts |
United States | Wake Forest Baptist Health Eye Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Clearside Biomedical, Inc. |
United States, India, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 24 weeks | |
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. Only images that were gradable by the central reading center were included in the analysis. | Baseline, 24 weeks | |
Secondary | 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. | Baseline to 24 weeks |
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