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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Open Angle Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TGF-β2 antisense oligonucleotide

Core Study: Administered intravitreally at the time of trabeculectomy at escalating doses

Post-Study Follow-up: until 1 year after administration

Group Type EXPERIMENTAL

TGF-β2 antisense oligonucleotide

Intervention Type DRUG

intravitreal injection

Trabeculectomy

Intervention Type PROCEDURE

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

Interventions

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TGF-β2 antisense oligonucleotide

intravitreal injection

Intervention Type DRUG

Trabeculectomy

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

Intervention Type PROCEDURE

Other Intervention Names

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ISTH0036

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No