ROH-101 phase 3 study - uncontrolled open-label study in patients with cytomegalovirus corneal endotheliitis -

JRCT ID: jRCT2051210064

Registered date:13/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: cytomegalovirus corneal endotheliitis
• Date of first enrollment: 02/08/2021
• Target sample size: 12
• Study type: Interventional
• Intervention(s): One drop of ROH-101(0.15%) 5 times a day for 12 weeks

Outcome(s)

• Primary Outcome: The percentage of patients who achieved <1000 copies /ml(detected limit) in aqueous humor Real-time PCR

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who diagnose as CMV endotheliitis based on the clinical manifestations of (1) or (2).
(1) Patients who show coin-shaped lesions or linear 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.

• Exclude criteria: 1) Patients who are HSV or VZV positive by examination of qualitative PCR of aqueous humor.

Related Information

• Primary Sponsor: Kitano Takashi