Clinical trial NCT02406833: Phase I Dose Escalation Study to Investigate the Safety of ISTH0036 in Subjects With Glaucoma Undergoing Trabeculectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Open Angle Glaucoma
Keywords: glaucoma
trabeculectomy
Lead sponsor: Isarna Therapeutics GmbH
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE)
timeFrame: 1 year
Secondary outcomes:
measure: Intraocular pressure
timeFrame: 1 year
measure: Number of interventions post trabeculectomy
timeFrame: 1 year
measure: Visual field
timeFrame: 1 year
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: University Hospital Magdeburg, Ophthalmology
city: Mainz
country: Germany
facility: Department of Ophthalmology, Johannes-Gutenberg University Mainz
city: Tuebingen
country: Germany
facility: University of Tuebingen, Center of Ophthalmology
Study officials:
affiliation: Isarna Therapeutics
name: Petra Fettes, PhD
role: STUDY_DIRECTOR
References: