VitrectomyPhase 1NCT02644694
PK Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Undergoing Vitrectomy
A Phase 1 study testing Dexamethasone Phosphate Ophthalmic Solution in people with Vitrectomy, run by Eyegate Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vitrectomy
- What is being tested?
- Dexamethasone Phosphate Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Nov 2016
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years
- Receive, understand, and sign a copy of the written informed consent form
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
About this study
Official title: A Prospective, Multi-Center, Single-Dose, Phase 1 Clinical Trial Designed to Evaluate the Pharmacokinetics of Dexamethasone Phosphate Ophthalmic Solution Delivered Via the EyeGate® II Drug Delivery System in Patients Undergoing Vitrectomy for Macular Hole Repair or Epiretinal Membrane Peeling
The purpose of this study is to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling
Read the detailed description
This is an open-label, multi-center, single-dose, Phase 1 clinical trial designed to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in the vitreous humor taken from patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling
- Conditions
- Vitrectomy
- Being tested
- Dexamethasone Phosphate Ophthalmic Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Phosphate Ophthalmic SolutionDrug
Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Phosphate Ophthalmic Solution | Experimental | Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System Receives: Drug: Dexamethasone Phosphate Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of dexamethasone
Vitreous humor samples will be analyzed for dexamethasone concentrations
Measured: Day 1
Concentration of dexamethasone phosphate
Vitreous humor samples will be analyzed for dexamethasone phosphate concentrations
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitrectomyStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Heier, M.D., Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644694
- Sponsor's protocol ID
- EGP-437-010
- Status last verified
- Jun 2016
- First submitted
- 22 Dec 2015
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Single-Dose, Phase 1 Clinical Trial Designed to Evaluate the Pharmacokinetics of Dexamethasone Phosphate Ophthalmic Solution Delivered Via the EyeGate® II Drug Delivery System in Patients Undergoing Vitrectomy for Macular Hole Repair or Epiretinal Membrane Peeling
- ClinicalTrials.gov ID
- NCT02644694
- Acronym / sponsor ID
- EGP-437-010
- Conditions
- Vitrectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Jan 2016 (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 evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling
Detailed description
This is an open-label, multi-center, single-dose, Phase 1 clinical trial designed to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in the vitreous humor taken from patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Phosphate Ophthalmic Solution | Experimental | Drug: Dexamethasone Phosphate Ophthalmic SolutionExperimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 to 85 years
- Receive, understand, and sign a copy of the written informed consent form
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Dexamethasone Phosphate Ophthalmic SolutionExperimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System | Drug | Dexamethasone Phosphate Ophthalmic Solution |
Primary outcome
Concentration of dexamethasone
Time frame: Day 1
Vitreous humor samples will be analyzed for dexamethasone concentrations
Concentration of dexamethasone phosphate
Time frame: Day 1
Vitreous humor samples will be analyzed for dexamethasone phosphate concentrations
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 7 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.
Jeffrey Heier, M.D. principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone Phosphate Ophthalmic Solution in people with Vitrectomy, run by Eyegate Pharmaceuticals, Inc. 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 2 inclusion and 1 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 7 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 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?
Concentration of dexamethasone (time frame: Day 1). The study lists 2 primary outcomes in all. 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 7 Feb 2017.