Phase I Dose Escalation Study to Investigate the Safety of ISTH0036 in Subjects With Glaucoma Undergoing Trabeculectomy

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the addition of ISTH0036, an antisense oligonucleotide against TGF-β2, to glaucoma filtration surgery (trabeculectomy). The treatment aims at improving the surgery outcome by prevention of excessive scarring and trabecular meshwork transformation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isarna Therapeutics GmbH

Criteria

Inclusion Criteria:

• Subject scheduled for trabeculectomy with Mitomycin C

• Subject no longer tolerating or benefitting from pharmacologic treatment of glaucoma

Exclusion Criteria:

• History of relevant ocular trauma < 6 months or ocular infection/inflammation < 3 months

• severe central visual field loss within 6 months unrelated to glaucoma

• pregnant or nursing women or subjects not using adequate contraception

• history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluations, procedures or interpretation