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

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ClinicalTrials.gov Identifier: NCT02406833
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Isarna Therapeutics GmbH

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.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Drug: TGF-β2 antisense oligonucleotide Procedure: Trabeculectomy Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2017


Arm Intervention/treatment
Experimental: 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

Drug: TGF-β2 antisense oligonucleotide
intravitreal injection
Other Name: ISTH0036

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Intraocular pressure [ Time Frame: 1 year ]
  2. Number of interventions post trabeculectomy [ Time Frame: 1 year ]
  3. Visual field [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406833


Locations
Germany
University Hospital Magdeburg, Ophthalmology
Magdeburg, Germany, 39120
Department of Ophthalmology, Johannes-Gutenberg University Mainz
Mainz, Germany, 55131
University of Tuebingen, Center of Ophthalmology
Tuebingen, Germany, 72076
Sponsors and Collaborators
Isarna Therapeutics GmbH
Investigators
Study Director: Petra Fettes, PhD Isarna Therapeutics

Responsible Party: Isarna Therapeutics GmbH
ClinicalTrials.gov Identifier: NCT02406833     History of Changes
Other Study ID Numbers: ISTH-01-111
2014-004985-74 ( EudraCT Number )
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by Isarna Therapeutics GmbH:
glaucoma
trabeculectomy

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases