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ST-605 phase 2 study

ST-605 phase 2 study - uncontrolled open-label study in patients with cytomegalovirus corneal endotheliitis -

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223131
Enrollment
5
Registered
2016-03-07
Start date
2016-03-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CMV corneal endotheliitis

Interventions

Sponsors

M's Science Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who diagnose as CMV endotheliitis based on the clinical manifestations of (1) or (2). (1) Patients who show coin-shaped lesionsl or inear keratic precipitates (KPs). (2) Patients who show other KPs combined with more than 2 of following signs; anterior uveitis, ocular hypertension and corneal endothelial cell loss. 2) Patients who are CMV DNA positive by examination of qualitative PCR of aqueous humor. 3) Patients who consent for collecting aqueous humor by anterior chamber tap.

Exclusion criteria

Exclusion criteria: 1) Patients who are HSV or VZV positive by examination of qualitative PCR of aqueous humor. 2) Patients who diagnose as CMV endotheliitis with other causes than CMV. 3) Patients who receive anti-CMV drugs such as ganciclovir, valganciclovir or foscarnet within 4 weeks of enrollment. 4) Patients who are allergic to ganciclovir. 5) Patients who diagnose CMV retinopathy.

Design outcomes

Primary

MeasureTime frame
Clinical manifestations, BCVA, IOP, corneal endothelial cell density, central corneal thickness and corneal volume Slit-lamp examination, specular microscope, pentacam or anterior segment OCT

Secondary

MeasureTime frame
CMV DNA copy numbers in aqueous humor Real-time PCR

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026