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SUPRACHOROIDAL INJECTION OF TRIAMCINOLONE ACETONIDE, CLS-TA, FOR MACULAR EDEMA DUE TO NONINFECTIOUS UVEITIS: A Randomized, Phase 2 Study (DOGWOOD)

Yeh, Steven, MD*; Kurup, Shree K., MD; Wang, Robert C., MD; Foster, C. Stephen, MD§,¶,**; Noronha, Glenn, PhD††; Nguyen, Quan Dong, MD, MSc‡‡; Do, Diana V., MD‡‡ for the DOGWOOD Study Team

doi: 10.1097/IAE.0000000000002279
Original Study: PDF Only

Purpose: Evaluate a single suprachoroidal injection of a proprietary triamcinolone acetonide suspension, CLS-TA, in subjects with macular edema due to noninfectious uveitis.

Methods: Randomized, controlled, masked Phase 2 study. Safety and efficacy of a single suprachoroidal injection of CLS-TA (4.0 and 0.8 mg in a 4:1 ratio) were assessed at 1 and 2 months after injection. The primary efficacy endpoint was change in central subfield thickness from baseline to Month 2, assessed by spectral domain optical coherence tomography.

Results: Twenty-two adults were enrolled. The primary endpoint was met in subjects who received suprachoroidal injection of CLS-TA 4.0 mg, mean central subfield thickness significantly decreased from baseline by 135 µm and 164 µm at Month 1 (P = 0.0056) and Month 2 (P = 0.0017), respectively. At Month 2, 69% of subjects who received 4.0 mg experienced ≥20% reduction in central subfield thickness, and 65% had improvement of best-corrected visual acuity of ≥5 Early Treatment Diabetic Retinopathy Study letters, with a mean improvement of 9.2 letters (P = 0.0004). Safety analyses supported acceptable safety/tolerability, with no corticosteroid-related increases in intraocular pressure.

Conclusion: A single suprachoroidal injection of CLS-TA (4.0 mg; 0.1 mL) in subjects with macular edema due to noninfectious uveitis was well-tolerated, significantly reduced central subfield thickness from baseline at 2 months, and significantly improved visual acuity.

Data from a Phase 2 study of a single suprachoroidal injection of CLS-TA support continued development of this triamcinolone acetonide suspension as a local approach to the potential treatment of patients with macular edema because of noninfectious uveitis.

*Emory Global Health Institute, Emory University School of Medicine, Atlanta, Georgia;

Retina Center, Tucson, Arizona;

Texas Retina Associates, Dallas, Texas;

§Massachusetts Eye Research and Surgery Institution, Waltham, Massachusetts;

Ocular Immunology and Uveitis Foundation, Waltham, Massachusetts;

**Harvard Medical School, Boston, Massachusetts;

††Clearside Biomedical, Inc, Alpharetta, Georgia; and

‡‡Byers Eye Institute, Stanford University, Palo Alto, California.

Reprint requests: Diana V. Do, MD, Byers Eye Institute, Stanford University School of Medicine, 2370 Watson Court, Suite 228, Palo Alto, CA 94303; e-mail: dianado@stanford.edu

The clinical trial and its publication were supported by Clearside Biomedical, Inc.

Data from this study were presented in part at the American Society of Retina Specialists Annual Meeting, San Francisco, CA, August 9−14, 2016, at a Subspecialty Day held in conjunction with the American Academy of Ophthalmology Annual Meeting, Chicago, IL, October 15−18, 2016, and at the International Ocular Inflammation Society Congress, Lausanne, Switzerland, October 18−21, 2017.

S. Yeh reports consulting fees from Clearside Biomedical Inc and Santen. S. K. Kurup reports consulting fees from Clearside Biomedical Inc. R. C. Wang reports consulting fees from Mallinckrodt and speaking fees from AbbVie. C. S. Foster reports consulting fees from Novartis; grants from EyeGate Pharma; having served as an investigator for Mallinckrodt and Novartis; investigator grants from Aciont, Aldeyra Therapeutics, Allergan, Bausch & Lomb Surgical, Clearside Biomedical, Inc, Dompe, pSivida, and Santen; speaker grants from Mallinckrodt; and stock holdings in EyeGate Pharma. G. Noronha is an employee of Clearside Biomedical Inc. and reports a patent pending. Q. D. Nguyen reports advisory board fees from Clearside Biomedical Inc. D. V. Do reports consulting fees from Clearside Biomedical Inc, Genentech, and Santen; and research funding from Genentech, Regeneron, and Santen.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.retinajournal.com).

The sponsor participated in the design of the study, conducting the study, data collection, data management, data analysis, interpretation of the data, and the preparation, review, and approval of the manuscript.

© 2018 by Ophthalmic Communications Society, Inc.