Suprachoroidal Injection of Triamcinolone Acetonide, Cls-Ta, for Macular Edema due to Noninfectious Uveitis: A Randomized, Phase 2 Study (DOGWOOD)

Steven Yeh, Shree K. Kurup, Robert C. Wang, C. Stephen Foster, Glenn Noronha, Quan Dong Nguyen, Diana V. Do

Research output: Contribution to journalArticlepeer-review

54 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1880-1888
Number of pages9
JournalRetina
Volume39
Issue number10
DOIs
StatePublished - Oct 1 2019
Externally publishedYes

Keywords

  • CLS-TA
  • Phase 2
  • clinical trial
  • macular edema
  • suprachoroidal space
  • triamcinolone acetonide
  • uveitis

ASJC Scopus subject areas

  • Ophthalmology

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