Primary Open Angle GlaucomaPhase 1NCT02406833
Phase I Dose Escalation Study to Investigate the Safety of ISTH0036 in Subjects With Glaucoma Undergoing Trabeculectomy
A Phase 1 study testing TGF-β2 antisense oligonucleotide and Trabeculectomy in people with Primary Open Angle Glaucoma, run by Isarna Therapeutics GmbH at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- TGF-β2 antisense oligonucleotide and Trabeculectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesGermany
- Study dates
- Apr 2015to Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject scheduled for trabeculectomy with Mitomycin C
- Subject no longer tolerating or benefitting from pharmacologic treatment of glaucoma
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Hospital Magdeburg, Ophthalmology
Magdeburg, 39120
Department of Ophthalmology, Johannes-Gutenberg University Mainz
Mainz, 55131
University of Tuebingen, Center of Ophthalmology
Tübingen, 72076
About this study
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
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.
Read the 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.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- TGF-β2 antisense oligonucleotide, Trabeculectomy
- Keywords
- glaucoma, trabeculectomy
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGF-β2 antisense oligonucleotideDrug
Also called ISTH0036
intravitreal injection
TrabeculectomyProcedure or surgery
Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control
| Study group | Role | What they receive |
|---|---|---|
| TGF-β2 antisense oligonucleotide | Experimental | Core Study: Administered intravitreally at the time of trabeculectomy at escalating doses
Post-Study Follow-up: until 1 year after administration Receives: Drug: TGF-β2 antisense oligonucleotide; Procedure: Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE)
Measured: 1 year
Secondary outcomes (3)
Intraocular pressure
Measured: 1 year
Number of interventions post trabeculectomy
Measured: 1 year
Visual field
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isarna Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petra Fettes, PhD, Study director, Isarna Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406833
- Sponsor's protocol ID
- ISTH-01-111
- Other IDs
- 2014-004985-74, 2014
- Status last verified
- Feb 2018
- First submitted
- 25 Mar 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02406833
- Acronym / sponsor ID
- ISTH-01-111
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- glaucoma, trabeculectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Isarna Therapeutics GmbHIndustry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TGF-β2 antisense oligonucleotide | Experimental | Drug: TGF-β2 antisense oligonucleotide, Procedure: TrabeculectomyCore Study: Administered intravitreally at the time of trabeculectomy at escalating doses Post-Study Follow-up: until 1 year after administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject scheduled for trabeculectomy with Mitomycin C
- Subject no longer tolerating or benefitting from pharmacologic treatment of glaucoma
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGF-β2 antisense oligonucleotideAlso: ISTH0036intravitreal injection | Drug | TGF-β2 antisense oligonucleotide |
| TrabeculectomyStandard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control | Procedure or surgery | TGF-β2 antisense oligonucleotide |
Primary outcome
Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE)
Time frame: 1 year
3 secondary outcomes
Intraocular pressure
Time frame: 1 year
Number of interventions post trabeculectomy
Time frame: 1 year
Visual field
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Fettes, PhD study director
Isarna Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TGF-β2 antisense oligonucleotide and Trabeculectomy in people with Primary Open Angle Glaucoma, run by Isarna Therapeutics GmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.