This trial is active, not recruiting.

Condition primary open angle glaucoma
Treatments tgf-β2 antisense oligonucleotide, trabeculectomy
Phase phase 1
Sponsor Isarna Therapeutics GmbH
Start date April 2015
End date August 2016
Trial size 13 participants
Trial identifier NCT02406833, 2014-004985-74, ISTH-01-111


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Core Study: Administered intravitreally at the time of trabeculectomy at escalating doses Post-Study Follow-up: until 1 year after administration
tgf-β2 antisense oligonucleotide ISTH0036
intravitreal injection
Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control

Primary Outcomes

Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE)
time frame: 1 year

Secondary Outcomes

Intraocular pressure
time frame: 1 year
Number of interventions post trabeculectomy
time frame: 1 year
Visual field
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title A Phase I, Open-Label, Dose-Escalation Study to Investigate the Safety of ISTH0036, a 'Next Generation' TGF-β2-Selective Antisense Oligonucleotide, in Subjects With Primary Open-Angle Glaucoma Undergoing Trabeculectomy
Description The transforming growth factor beta (TGF-β) is known to play a key role in glaucoma. Increased levels of TGF-β2 in the eye have been linked to trabecular meshwork transformation, increased intraocular pressure and direct optic nerve damage. Trabeculectomy is the standard surgical intervention to reduce intraocular pressure in subjects no longer sufficiently responding to pressure-lowering medications. Scarring of the surgically opened canal (bleb) often abolishes the effect of trabeculectomy (despite the intraoperative use of Mitomycin C to prevent this). TGF-β2 has been described to play a distinct role in the fibrotic process of bleb closure.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Isarna Therapeutics GmbH.