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Completed

NCT Number: NCT02406833

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

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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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Magdeburg, Ophthalmology, Magdeburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TGF-β2 antisense oligonucleotide

Drug

intravitreal injection

Other names: ISTH0036

trabeculectomy

Procedure

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

Primary outcomes

  1. 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

  1. Intraocular pressure

    Time frame: 1 year

  2. Number of interventions post trabeculectomy

    Time frame: 1 year

  3. Visual field

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Isarna Therapeutics GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 2, 2015
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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