Macular EdemaPhase 1/2NCT02485249
Open-label, Multli-center, Phase 1b/2a Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients With Macular Edema
A Phase 1/2 study testing Dexamethasone Phosphate Ophthalmic in people with Macular Edema, run by Eyegate Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, EGP-437, using the EyeGate® II Drug Delivery System (EGDS) in patients with macular edema (ME) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Macular Edema
- What is being tested?
- Dexamethasone Phosphate Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age 18 to 90 years 2. Have diagnosis of ME secondary to one of the following diagnosed conditions:
- Central or branch retinal vein occlusion (CRVO or BRVO) with a mean CST ≥ 300µm on SD-OCT images taken at the baseline visit (Day 0)
- Diabetic macular edema (DME) with a mean CST ≥ 300µm on SD-OCT images taken at the baseline visit (Day 0)
- Cystoid macular edema (CME) secondary to having undergone a previous PPV and having a mean CST ≥ 300µm on SD-OCT images taken at the baseline visit (Day 0) having a history of previous positive response to steroid treatment 3. Receive, understand, and sign a copy of the ICF 4. Be able to return for all study visits and willing to comply with all study related instructions
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
About this study
To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, EGP-437, using the EyeGate® II Drug Delivery System (EGDS) in patients with macular edema (ME)
Read the detailed description
This will be a Phase 1b/2a, exploratory, open-label study, in which up to 20 eligible ME patients will be enrolled at up to 5 clinical sites in the U.S. Twenty eyes of 20 patients will be enrolled which means that only one eye will be treated with study treatment in patients who present at Visit 1 with bilateral ME. In situations where both eyes of a patient are eligible for the study, the eye with the shorter duration of ME will be the study eye.9 The investigator will designate the study eye when both eligible eyes have been diagnosed with ME at the same time. Potential patients who are interested in participating in the study will be provided an informed consent form (ICF) prior to screening. Patient eligibility will be assessed at Visit 1 (Day 0), the baseline visit, by spectral SD-OCT and measurement of IOP, in addition to review of the patient's medical and ophthalmic history and recent concomitant medications history. Study Treatment will be administered on Day 0, Day 4, and Day 9 (Visits 1, 2, and 3). Subjects will be scheduled to return to the clinic for post-treatment assessments during Visits 4 and 5 (Day 14 and Day 21 or Day 28).
- Conditions
- Macular Edema
- Being tested
- Dexamethasone Phosphate Ophthalmic
- Keywords
- Iontophoresis, Macular Edema, Ophthalmology
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Phosphate OphthalmicDrug
Also called 40 mg/mL Dexamethasone Phosphate Ophthalmic
Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Phosphate | Experimental | Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 14.0 mA-min at 3.5 mA on Day 0, Day 4, and Day 14 Receives: Drug: Dexamethasone Phosphate Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic improvement measured as reduction in mean central subfield thickness as evaluated by spectral-domain-optical coherence tomography
Measured: Day 4, Day 9, Day 14, and Day 21
Secondary outcomes (3)
Changes in macular volume as evaluated by spectral-domain-optical coherence tomography
Measured: Day 4, Day 9, Day 14, and Day 21
Qualitative review of spectral-domain-optical coherence tomography scans
Measured: Day 4, Day 9, Day 14, and Day 21
Dilated fundus exam
Measured: Day 4, Day 9, Day 14, and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Brandano, Study director, EyeGate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485249
- Sponsor's protocol ID
- EGP-437-007
- Status last verified
- Aug 2016
- First submitted
- 26 Jun 2015
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multli-center, Phase 1b/2a Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients With Macular Edema
- ClinicalTrials.gov ID
- NCT02485249
- Acronym / sponsor ID
- EGP-437-007
- Conditions
- Macular Edema
- Keywords
- Iontophoresis, Macular Edema, Ophthalmology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jun 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.
To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, EGP-437, using the EyeGate® II Drug Delivery System (EGDS) in patients with macular edema (ME)
Detailed description
This will be a Phase 1b/2a, exploratory, open-label study, in which up to 20 eligible ME patients will be enrolled at up to 5 clinical sites in the U.S. Twenty eyes of 20 patients will be enrolled which means that only one eye will be treated with study treatment in patients who present at Visit 1 with bilateral ME. In situations where both eyes of a patient are eligible for the study, the eye with the shorter duration of ME will be the study eye.9 The investigator will designate the study eye when both eligible eyes have been diagnosed with ME at the same time. Potential patients who are interested in participating in the study will be provided an informed consent form (ICF) prior to screening. Patient eligibility will be assessed at Visit 1 (Day 0), the baseline visit, by spectral SD-OCT and measurement of IOP, in addition to review of the patient's medical and ophthalmic history and recent concomitant medications history. Study Treatment will be administered on Day 0, Day 4, and Day 9 (Visits 1, 2, and 3). Subjects will be scheduled to return to the clinic for post-treatment assessments during Visits 4 and 5 (Day 14 and Day 21 or Day 28).
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 | Experimental | Drug: Dexamethasone Phosphate OphthalmicDexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 14.0 mA-min at 3.5 mA on Day 0, Day 4, and Day 14 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Age 18 to 90 years 2. Have diagnosis of ME secondary to one of the following diagnosed conditions:
Key exclusion criteria (0 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 OphthalmicAlso: 40 mg/mL Dexamethasone Phosphate OphthalmicTransscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) | Drug | Dexamethasone Phosphate |
Primary outcome
Anatomic improvement measured as reduction in mean central subfield thickness as evaluated by spectral-domain-optical coherence tomography
Time frame: Day 4, Day 9, Day 14, and Day 21
3 secondary outcomes
Changes in macular volume as evaluated by spectral-domain-optical coherence tomography
Time frame: Day 4, Day 9, Day 14, and Day 21
Qualitative review of spectral-domain-optical coherence tomography scans
Time frame: Day 4, Day 9, Day 14, and Day 21
Dilated fundus exam
Time frame: Day 4, Day 9, Day 14, and Day 21
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Macular Edema
Active, not recruitingPhase 2/3
A Study of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME
Diabetic Macular Edema (DME)
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2/3
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
Diabetic Retinopathy
RecruitingPhase 2
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
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.
Lisa Brandano study director
EyeGate
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 Dexamethasone Phosphate Ophthalmic in people with Macular Edema, 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 4 inclusion and 0 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: stopped early, as of the sponsor's last update on 3 Aug 2016. 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 was stopped early (reason given: Slow enrollment). Results are not available in the source record.
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?
Anatomic improvement measured as reduction in mean central subfield thickness as evaluated by spectral-domain-optical coherence tomography (time frame: Day 4, Day 9, Day 14, and Day 21). 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 3 Aug 2016.