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

Primary Purpose

Primary Open Angle Glaucoma

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
TGF-β2 antisense oligonucleotide
Trabeculectomy
Sponsored by
Isarna Therapeutics GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring glaucoma, trabeculectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Magdeburg, Ophthalmology
  • Department of Ophthalmology, Johannes-Gutenberg University Mainz
  • University of Tuebingen, Center of Ophthalmology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TGF-β2 antisense oligonucleotide

Arm Description

Core Study: Administered intravitreally at the time of trabeculectomy at escalating doses Post-Study Follow-up: until 1 year after administration

Outcomes

Primary Outcome Measures

Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE)

Secondary Outcome Measures

Intraocular pressure
Number of interventions post trabeculectomy
Visual field

Full Information

First Posted
March 25, 2015
Last Updated
February 27, 2018
Sponsor
Isarna Therapeutics GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02406833
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Isarna Therapeutics GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
glaucoma, trabeculectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TGF-β2 antisense oligonucleotide
Arm Type
Experimental
Arm Description
Core Study: Administered intravitreally at the time of trabeculectomy at escalating doses Post-Study Follow-up: until 1 year after administration
Intervention Type
Drug
Intervention Name(s)
TGF-β2 antisense oligonucleotide
Other Intervention Name(s)
ISTH0036
Intervention Description
intravitreal injection
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy
Intervention Description
Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Intraocular pressure
Time Frame
1 year
Title
Number of interventions post trabeculectomy
Time Frame
1 year
Title
Visual field
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Fettes, PhD
Organizational Affiliation
Isarna Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Magdeburg, Ophthalmology
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Department of Ophthalmology, Johannes-Gutenberg University Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
University of Tuebingen, Center of Ophthalmology
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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