Primary Open Angle GlaucomaPhase 1/2POAGNCT03065036
Safety and Efficacy Study of the Hydrus Aqueous Implant in Subjects With POAG
A Phase 1/2 study testing prestudy topical glaucoma medications in people with Primary Open Angle Glaucoma, run by Ivantis, Inc. at 5 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- prestudy topical glaucoma medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Mar 2010to Feb 2014
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated intraocular pressure (IOP)
- Diagnosis of mild to advanced open-angle glaucoma
- Shaffer Grade III
- Mental capacity to cooperate when undergoing operative and postoperative examination
- 18 years of age or older
- Provide written informed consent
- Willing and able to return to scheduled follow-up examinations for 24-months
Who cannot join
- Closed-angle and narrow-angle forms of glaucoma
- Secondary glaucomas
- Congenital or developmental glaucoma
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany3 sites
Study site
Berlin, 10559
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik
Mainz, 55131
Aurelios Augenzentrum
Recklinghausen, Erlbruch
About this study
Official title: A Prospective, Multi-Center Evaluation of the Hydrus Aqueous Implant (Standard and Low-Profile) for Lowering Intraocular Pressure (IOP) in Subjects With Mild to Advanced Primary Open Angle Glaucoma (POAG) With or Without a Cataract
The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.
Read the detailed description
This is a prospective, multi-center study that will examine subjects with documented mild to advanced primary open angle glaucoma (POAG), who may or may not have a cataract requiring removal and placement of an intraocular lens.
Study subjects will be grouped by the severity of their disease (either mild/moderate or advanced). If all inclusion and exclusion criteria are met subjects in all four groups will be implanted with the Hydrus Aqueous Implant. Subjects in whom a cataract is present will undergo standard cataract removal and IOL implantation concurrent with implantation of the Hydrus.
Postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- prestudy topical glaucoma medications
- Keywords
- Primary Open Angle Glaucoma, POAG
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prestudy topical glaucoma medicationsDrug
Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.
| Study group | Role | What they receive |
|---|---|---|
| Hydrus Aqueous Implant | Experimental | Hydrus implanted into Schlemm's Canal. Receives: Drug: prestudy topical glaucoma medications |
| IOL placement and Hydrus implant | Other | Cataract Extraction with IOL placement and Hydrus implant into Schlemm's canal Receives: Drug: prestudy topical glaucoma medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IOP of study eye between each randomized group
Effectiveness will be determined by comparing the IOP at the baseline (pre-operative) visit to the the IOP at the 12 month post-operative visit.
Measured: Baseline & One year
Secondary outcomes (1)
Change in glaucoma medications
Calculate the change in the number of glaucoma medications from baseline (pre-operative) visit to the 12-month post-operative visit.
Measured: Baseline & One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study startMar 2010
- Primary completionNov 2013
- Study completionFeb 2014
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivantis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Manfred Tetz, MD, Principal investigator, Augentagesklinik Spreebogen Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065036
- Sponsor's protocol ID
- CP-09-001
- Other IDs
- HYDRUS I
- Acronym
- POAG
- Status last verified
- Jan 2019
- First submitted
- 29 Feb 2012
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Evaluation of the Hydrus Aqueous Implant (Standard and Low-Profile) for Lowering Intraocular Pressure (IOP) in Subjects With Mild to Advanced Primary Open Angle Glaucoma (POAG) With or Without a Cataract
- ClinicalTrials.gov ID
- NCT03065036
- Acronym / sponsor ID
- POAG / CP-09-001
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Primary Open Angle Glaucoma, POAG
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ivantis, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Feb 2017 (actual)
- 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.
The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.
Detailed description
This is a prospective, multi-center study that will examine subjects with documented mild to advanced primary open angle glaucoma (POAG), who may or may not have a cataract requiring removal and placement of an intraocular lens.
Study subjects will be grouped by the severity of their disease (either mild/moderate or advanced). If all inclusion and exclusion criteria are met subjects in all four groups will be implanted with the Hydrus Aqueous Implant. Subjects in whom a cataract is present will undergo standard cataract removal and IOL implantation concurrent with implantation of the Hydrus.
Postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrus Aqueous Implant | Experimental | Drug: prestudy topical glaucoma medicationsHydrus implanted into Schlemm's Canal. |
| IOL placement and Hydrus implant | Other | Drug: prestudy topical glaucoma medicationsCataract Extraction with IOL placement and Hydrus implant into Schlemm's canal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Elevated intraocular pressure (IOP)
- Diagnosis of mild to advanced open-angle glaucoma
- Shaffer Grade III
- Mental capacity to cooperate when undergoing operative and postoperative examination
- 18 years of age or older
Key exclusion criteria (3 listed)
- Closed-angle and narrow-angle forms of glaucoma
- Secondary glaucomas
- Congenital or developmental glaucoma
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 |
|---|---|---|
| prestudy topical glaucoma medicationsReintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary. | Drug | Hydrus Aqueous Implant, IOL placement and Hydrus implant |
Primary outcome
Change in IOP of study eye between each randomized group
Time frame: Baseline & One year
Effectiveness will be determined by comparing the IOP at the baseline (pre-operative) visit to the the IOP at the 12 month post-operative visit.
1 secondary outcome
Change in glaucoma medications
Time frame: Baseline & One 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 4 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Prof. Dr. Manfred Tetz, MD principal investigator
Augentagesklinik Spreebogen Berlin
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing prestudy topical glaucoma medications in people with Primary Open Angle Glaucoma, run by Ivantis, Inc. at 5 sites in 3 countries.
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 7 inclusion and 3 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Austria, Mexico. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in IOP of study eye between each randomized group (time frame: Baseline & One 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 4 Feb 2019.