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J. Austin Clayton, C. Perry, M. Robinson; A Phase I Clinical Trial to Study the Safety of a Sustained-Release Subconjunctival Cyclosporine (CsA) Implant for Ocular Graft-vs.-Host Disease (GVHD). Invest. Ophthalmol. Vis. Sci. 2009;50(13):4680.
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© ARVO (1962-2015); The Authors (2016-present)
To investigate the safety and potential efficacy of a novel, subconjunctival CsA implant in active systemic GVHD with aqueous tear deficiency due to lacrimal gland involvement.
Participants (pts) were randomized to 0.5 or 0.75 inch, 30% drug load, CsA impant. Standardized ocular surface disease (OSD) evaluation included tear production and stability, dye staining, meibomian gland function (MGD), Ocular Surface Disease Index and signal grading of "the main complaint" per eye. Safety and preliminary efficacy were assessed with pre-specified clinical success criteria for change from baseline or achievement of mild-moderate OSD.
2 year follow-up (f/u) data are available for 4 pts: 2 White males, 1 Asian female, and 1 White Hispanic female. At baseline, 3/4 pts showed severe OSD OU (study eye, SE, and fellow eye, FE): corneal (K) staining ≥ 3, total conjunctival (conj) and K staining ≥ 12, maximum MGD score of 3, Schirmer (Sch) of 1 mm, and did not meet criteria for mild-moderate OSD. At 2 yrs, 4/4 SE’s and 1/4 FE’s met ≥ half of clinical success measures. 4/4 SE’s met success measures: improved K and conj staining (by ≥ 2), K staining ≤ 3, and nasal or temporal conj staining ≤ 3, while 2 FE’s showed improved K staining, K staining ≤ 3 and nasal and temporal conj staining ≤ 3. In 3/4 pts more success criteria were met in the SE than FE (SE, FE): Pt 1 (5, 0), Pt 2 (6, 2), Pt 3 (5, 2), Pt 4 (5, 5). 3/4 pts showed increased TBUT in the SE, vs.2/4 FE’s. 3/4 pts showed improved signal grading ≥ 2 points in the SE vs. 1 FE. 1 pt had improved OSDI score. F/u data for > 2 yrs is available for 2 pts who both showed additional reduction in K and conj staining to ≤ 1 and further increase in Schirmer in the SE, but not the FE, meeting the clinical success criterion in 1. No safety concerns were identified.
There is preliminary evidence from this small pilot study for improvement in severe OSD with subconjunctival CsA implants in subjects with active, systemic GVHD. Further study is need to optimize CsA delivery, duration and dosage.
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