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

Primary Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406833
• Other study ID #: ISTH-01-111
• Secondary ID: 2014-004985-74
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2015
• Last updated: February 27, 2018
• Start date: April 2015
• Est. completion date: August 2017

Study information

• Verified date: February 2018
• Source: Isarna Therapeutics GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Drug:
• TGF-ß2 antisense oligonucleotide
intravitreal injection

Procedure:
• Trabeculectomy
Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control

Locations

Country	Name	City	State
Germany	University Hospital Magdeburg, Ophthalmology	Magdeburg
Germany	Department of Ophthalmology, Johannes-Gutenberg University Mainz	Mainz
Germany	University of Tuebingen, Center of Ophthalmology	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
Isarna Therapeutics GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE)		1 year
Secondary	Intraocular pressure		1 year
Secondary	Number of interventions post trabeculectomy		1 year
Secondary	Visual field		1 year