Primary Open Angle Glaucoma
Conditions
Keywords
glaucoma, trabeculectomy
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.
Interventions
PROCEDURETrabeculectomy
Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control
DRUGTGF-β2 antisense oligonucleotide
intravitreal injection
Sponsors
Isarna Therapeutics GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Intraocular pressure | 1 year |
| Number of interventions post trabeculectomy | 1 year |
| Visual field | 1 year |
Countries
Germany
Outcome results
None listed