GlaucomaPhase 1/2NCT02051946
Novel Drug Delivery Technique Via Retroject Device
A Phase 1/2 study testing Retroject Device, ethacrynic acid injection and balanced salt solution in people with Glaucoma, run by Molly Walsh at 1 site in United States.
Trial summary
The purpose of this study is to identify whether or not injection of a study drug (ethacrynic acid) using the investigational Retroject device is able to lower eye pressures in patients with advanced glaucoma. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Retroject Device, ethacrynic acid injection and balanced salt solution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Oct 2015
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 55 years or older of both sexes
- IOP >20 mmHg on maximal treatment
- <20/200 visual acuity
- willing to sign informed consent forms
Who cannot join
- monocular patients with bleeding disorders
- patients on anticoagulant or antiplatelet medications
- patients who had prior laser surgeries (SLT or ALT)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Eye Center
Durham, North Carolina, 27710
About this study
Official title: Novel Drug Delivery Technique for Glaucoma Patients
The purpose of this study is to identify whether or not injection of a study drug (ethacrynic acid) using the investigational Retroject device is able to lower eye pressures in patients with advanced glaucoma. 20 patients with advanced glaucoma with visual acuity less than 20/200 and intraocular pressures (IOP) >20mmHg on maximum medical therapy will be asked to participate in the study. The first five patients will have the Retroject device placed over their eye for 30 seconds and then removed. Assuming no issues, then it will be placed on the eye for one minute. The second group of patients (3 total) will have the Retroject device placed on the eye and then an injection of ethacrynic acid into the episcleral vein. The third group of patients (12 total) will have the Retroject device placed on the eye and then will be randomized in a 2:1 ratio to receive either an ethacrynic acid injection or a balanced salt solution injection. All 20 patients will then return for intraocular pressure measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. In addition, the patients will undergo pre and post intervention corneal endothelial assessments (endothelial cell count, shape analysis, and pachymetry). Potential safety issues are unlikely and include bleeding, infection, pain, ototoxicity, or temporary or permanent loss of vision.
- Conditions
- Glaucoma
- Being tested
- Retroject Device, ethacrynic acid injection, balanced salt solution
- Keywords
- novel drug delivery technique for glaucoma patients
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroject DeviceDevice
ethacrynic acid injectionDrug
balanced salt solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Retroject device only | Active comparator | The first 5 patients enrolled will serve as controls and will have the device alone placed on the eye (without an injection of ethacrynic acid). Receives: Device: Retroject Device |
| Retroject injection with ethacrynic acid injection | Experimental | The next 3 patients, after the first 5 controls, will have the device placed on the eye with a subsequent injection of ethacrynic acid into the episcleral vein. Receives: Device: Retroject Device; Drug: ethacrynic acid injection |
| randomization to ethacrynic acid or balanced salt solution | Experimental | The last 12 patients will all have the device placed on their eye. They will then be randomized in a 2:1 ratio to receive either an injection of ethacrynic acid or balanced salt solution. Receives: Device: Retroject Device; Drug: ethacrynic acid injection; Drug: balanced salt solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular pressures (IOP) lowering effect
The patients will then return for intraocular pressure measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. Differences in baseline IOP versus post-injection IOP will be calculated for each patient.
Measured: Days 1, 2, 3, and 7, and 6 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molly Walsh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Molly Walsh, Duke University
- Investigators
- Rand Allingham, MD, Principal investigator, Duke University Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051946
- Sponsor's protocol ID
- Pro00039988
- Status last verified
- Feb 2017
- First submitted
- 29 Jan 2014
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Drug Delivery Technique for Glaucoma Patients
- ClinicalTrials.gov ID
- NCT02051946
- Acronym / sponsor ID
- Pro00039988
- Conditions
- Glaucoma
- Keywords
- novel drug delivery technique for glaucoma patients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Molly WalshUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 31 Jan 2014 (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.
The purpose of this study is to identify whether or not injection of a study drug (ethacrynic acid) using the investigational Retroject device is able to lower eye pressures in patients with advanced glaucoma. 20 patients with advanced glaucoma with visual acuity less than 20/200 and intraocular pressures (IOP) >20mmHg on maximum medical therapy will be asked to participate in the study. The first five patients will have the Retroject device placed over their eye for 30 seconds and then removed. Assuming no issues, then it will be placed on the eye for one minute. The second group of patients (3 total) will have the Retroject device placed on the eye and then an injection of ethacrynic acid into the episcleral vein. The third group of patients (12 total) will have the Retroject device placed on the eye and then will be randomized in a 2:1 ratio to receive either an ethacrynic acid injection or a balanced salt solution injection. All 20 patients will then return for intraocular pressure measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. In addition, the patients will undergo pre and post intervention corneal endothelial assessments (endothelial cell count, shape analysis, and pachymetry). Potential safety issues are unlikely and include bleeding, infection, pain, ototoxicity, or temporary or permanent loss of vision.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retroject device only | Active comparator | Device: Retroject DeviceThe first 5 patients enrolled will serve as controls and will have the device alone placed on the eye (without an injection of ethacrynic acid). |
| Retroject injection with ethacrynic acid injection | Experimental | Device: Retroject Device, Drug: ethacrynic acid injectionThe next 3 patients, after the first 5 controls, will have the device placed on the eye with a subsequent injection of ethacrynic acid into the episcleral vein. |
| randomization to ethacrynic acid or balanced salt solution | Experimental | Device: Retroject Device, Drug: ethacrynic acid injection, Drug: balanced salt solutionThe last 12 patients will all have the device placed on their eye. They will then be randomized in a 2:1 ratio to receive either an injection of ethacrynic acid or balanced salt solution. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 55 years or older of both sexes
- IOP >20 mmHg on maximal treatment
- <20/200 visual acuity
- willing to sign informed consent forms
Key exclusion criteria (3 listed)
- monocular patients with bleeding disorders
- patients on anticoagulant or antiplatelet medications
- patients who had prior laser surgeries (SLT or ALT)
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 |
|---|---|---|
| Retroject Device | Device | Retroject device only, Retroject injection with ethacrynic acid injection, randomization to ethacrynic acid or balanced salt solution |
| ethacrynic acid injection | Drug | Retroject injection with ethacrynic acid injection, randomization to ethacrynic acid or balanced salt solution |
| balanced salt solution | Drug | randomization to ethacrynic acid or balanced salt solution |
Primary outcome
Change in Intraocular pressures (IOP) lowering effect
Time frame: Days 1, 2, 3, and 7, and 6 weeks after injection
The patients will then return for intraocular pressure measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. Differences in baseline IOP versus post-injection IOP will be calculated for each patient.
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 17 Feb 2017.
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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.
Rand Allingham, MD principal investigator
Duke University Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Retroject Device, ethacrynic acid injection and balanced salt solution in people with Glaucoma, run by Molly Walsh at 1 site in United States.
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 4 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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Intraocular pressures (IOP) lowering effect (time frame: Days 1, 2, 3, and 7, and 6 weeks after injection). 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 17 Feb 2017.