Phase I Dose Escalation Study to Investigate the Safety of ISTH0036 in Subjects With Glaucoma Undergoing Trabeculectomy
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
2 other identifiers
interventional
13
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2015
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFebruary 28, 2018
February 1, 2018
1.3 years
March 25, 2015
February 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE)
1 year
Secondary Outcomes (3)
Intraocular pressure
1 year
Number of interventions post trabeculectomy
1 year
Visual field
1 year
Study Arms (1)
TGF-β2 antisense oligonucleotide
EXPERIMENTALCore Study: Administered intravitreally at the time of trabeculectomy at escalating doses Post-Study Follow-up: until 1 year after administration
Interventions
intravitreal injection
Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control
Eligibility Criteria
You may qualify if:
- Subject scheduled for trabeculectomy with Mitomycin C
- Subject no longer tolerating or benefitting from pharmacologic treatment of glaucoma
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University Hospital Magdeburg, Ophthalmology
Magdeburg, 39120, Germany
Department of Ophthalmology, Johannes-Gutenberg University Mainz
Mainz, 55131, Germany
University of Tuebingen, Center of Ophthalmology
Tübingen, 72076, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Petra Fettes, PhD
Isarna Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2015
First Posted
April 2, 2015
Study Start
April 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2017
Last Updated
February 28, 2018
Record last verified: 2018-02