Diabetic Macular EdemaPhase 2DMEONCT01951066
Diabetic Macular Edema Treated With Ozurdex (DMEO)
A Phase 2 study testing Dexamethasone Implant and Anti-VEGF injection in people with Diabetic Macular Edema, run by Johns Hopkins University at 1 site in United States.
Trial summary
To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Dexamethasone Implant and Anti-VEGF injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Signed informed consent and authorization of use and disclosure of protected health information
- Age more than or equal to 18 years
- Diagnosis of diabetic macular edema
- Intraretinal or subretinal fluid in the macula determined by Spectralis OCT
- Best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters)
- In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes of decreased vision
- Persistent or recurrent edema despite prolonged treatment with an anti-VEFG agent
Who cannot join
- • Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
- Intraocular surgery in the study eye within 3 months of study entry
- Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry
- Previous use of an anti-VEGF drug within 1 month of study entry
- Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry
- Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
Show all 12Show fewer
- Inability to comply with study or follow up procedures
- History of glaucoma. (Patients who have undergone filtration surgery may be included)
- Patients with active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
- Aphakic eyes with rupture of the posterior lens capsule.
- Eyes with ACIOL and rupture of the posterior lens capsule.
- Patients with hypersensitivity to dexamethasone or to any other components of the product
Trial locations and contacts
1 site in 1 country.
About this study
To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema
Read the detailed description
Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules targeting vascular endothelial factor (VEGF). One potential advantage of a dexamethasone implant over specific VEGF antagonists is that steroids suppress production of multiple pro-permeability factors.
Our primary objective is to measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 1, 2, 3, and 4 months after intraocular injection of a dexamethasone implant.
- Conditions
- Diabetic Macular Edema
- Being tested
- Dexamethasone Implant, Anti-VEGF injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone ImplantDrug
Patients will receive a single injection of a dexmethasone implant
Anti-VEGF injectionDrug
Patients will receive PRN injections of an anti-VEGF agent
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (dexamethasone implant/anti-VEGF) | Experimental | Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16. Receives: Drug: Dexamethasone Implant; Drug: Anti-VEGF injection |
| Group 2 (anti-VEGF/dexamethasone implant) | Experimental | Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16. Receives: Drug: Dexamethasone Implant; Drug: Anti-VEGF injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).
Measured: 1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter A Campochiaro, MD, Johns Hopkins University
- Investigators
- Peter A Campochiaro, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951066
- Sponsor's protocol ID
- DMEO-001
- Acronym
- DMEO
- Status last verified
- Aug 2016
- First submitted
- 20 Sep 2013
- Last updated
- 29 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Macular Edema Treated With Ozurdex (DMEO)
- ClinicalTrials.gov ID
- NCT01951066
- Acronym / sponsor ID
- DMEO / DMEO-001
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Sep 2013 (estimated)
- Results
- Posted 1 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema
Detailed description
Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules targeting vascular endothelial factor (VEGF). One potential advantage of a dexamethasone implant over specific VEGF antagonists is that steroids suppress production of multiple pro-permeability factors.
Our primary objective is to measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 1, 2, 3, and 4 months after intraocular injection of a dexamethasone implant.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (dexamethasone implant/anti-VEGF) | Experimental | Drug: Dexamethasone Implant, Drug: Anti-VEGF injectionPatients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16. |
| Group 2 (anti-VEGF/dexamethasone implant) | Experimental | Drug: Dexamethasone Implant, Drug: Anti-VEGF injectionPatients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Signed informed consent and authorization of use and disclosure of protected health information
Key exclusion criteria (12 listed)
- • Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
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 ImplantPatients will receive a single injection of a dexmethasone implant | Drug | Group 1 (dexamethasone implant/anti-VEGF), Group 2 (anti-VEGF/dexamethasone implant) |
| Anti-VEGF injectionPatients will receive PRN injections of an anti-VEGF agent | Drug | Group 1 (dexamethasone implant/anti-VEGF), Group 2 (anti-VEGF/dexamethasone implant) |
Primary outcome
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
Time frame: 1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent
Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter A Campochiaro, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone Implant and Anti-VEGF injection in people with Diabetic Macular Edema, run by Johns Hopkins University 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 7 inclusion and 12 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 29 Sep 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 1 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent (time frame: 1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent). 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 29 Sep 2016.