Diabetic Macular EdemaPhase 4ICODNCT04038125
Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME
A Phase 4 study testing Ozurdex Drug Implant Product in people with Diabetic Macular Edema and Diabetic Retinopathy, run by Retina Macula Specialists of Miami, LLC at 2 sites in United States.
Trial summary
The objective of this study is to test the hypothesis that following the use of intravitreal dexamethasone implant for the treatment of DME, there will be an observable increase in the capillary density plexus as denoted by the quantitative assessment of the superficial capillary plexus on OCTA, as well as a decrease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Diabetic Retinopathy, Retinal Ischemia
- What is being tested?
- Ozurdex Drug Implant Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Aug 2019to Aug 2021
- Phase
- Phase 4
- 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
- Age ≥ 18 years and Older.
- Diagnosis of diabetes mellitus (type 1 or type 2).
- At least one eye meets the study eye criteria listed.
- Visual Acuity 20/30 - 20/200 Snellen equivalent
- Have received no previous treatment for diabetic macular edema,(treatment naïve)
- Mild to Severe Non-proliferative Diabetic Retinopathy
- Diabetic macular edema present on optical coherence tomography (OCT) central subfield: ≥ 300µm.
- Able and willing to provide informed consent.
Who cannot join
- Have had any prior ocular treatment.
- Have had prior retinal surgical ( i.e. Pars plana vitrectomy). 3 .Have any clinical evidence of proliferative diabetic retinopathy.
- 4. Have a HBA1c of greater of 10%. 5. Evidence of Glaucoma or who are labeled glaucoma suspect at screening (defined as C/D >/= 0.5 with correlated NFLA thinning or IOP>25mmHg). 6. Have a contraindication to Ozurdex.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Retina Macula Specialists of Miami, LLC
North Miami Beach, Florida, 33162
Joyce Gonzalez, 305-655-0411, jgonzalez@retinamiami.com
Pamela Garcia, 306-643-8871, pjimenez@retinamiami.com
- Recruiting
Retina Macula Specialists of Miami, LLC
South Miami, Florida, 33143
Joyce Gonzalez, 305-666-8850, jgonzalez@retinamiami.com
Pamela Garcia, 305-643-8871, Pjimenez@retinamiami.com
About this study
Official title: Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME (RMSM ICOD STUDY)
The objective of this study is to test the hypothesis that following the use of intravitreal dexamethasone implant for the treatment of DME, there will be an observable increase in the capillary density plexus as denoted by the quantitative assessment of the superficial capillary plexus on OCTA, as well as a decrease in size of the foveal avascular zone (FAZ).
- Being tested
- Ozurdex Drug Implant Product
- Keywords
- Diabetic Macula Edema, Diabetic Retinopathy, Retina Ischemia
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozurdex Drug Implant ProductDrug
Also called Dexamethasone
Intravitreal Ozurdex injection
| Study group | Role | What they receive |
|---|---|---|
| Ozurdex Implant | Other | Intravitreal injection of Ozurdex implant Receives: Drug: Ozurdex Drug Implant Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate re perfusion following Ozurdex use.
Determined by OCT-A
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start22 Aug 2019
- Primary completionAug 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retina Macula Specialists of Miami, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Diana Shechtman, OD FAAO, Retina Macula Specialists of Miami, LLC
- Investigators
- Diana Shechtman, OD FAAO, Principal investigator, Retina Macula Specialists of Miami, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038125
- Sponsor's protocol ID
- LCH-0-012-019
- Acronym
- ICOD
- Status last verified
- Mar 2020
- First submitted
- 26 Jul 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME (RMSM ICOD STUDY)
- ClinicalTrials.gov ID
- NCT04038125
- Acronym / sponsor ID
- ICOD / LCH-0-012-019
- Keywords
- Diabetic Macula Edema, Diabetic Retinopathy, Retina Ischemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Retina Macula Specialists of Miami, LLCUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 30 Jul 2019 (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 objective of this study is to test the hypothesis that following the use of intravitreal dexamethasone implant for the treatment of DME, there will be an observable increase in the capillary density plexus as denoted by the quantitative assessment of the superficial capillary plexus on OCTA, as well as a decrease in size of the foveal avascular zone (FAZ).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ozurdex Implant | Other | Drug: Ozurdex Drug Implant ProductIntravitreal injection of Ozurdex implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years and Older.
- Diagnosis of diabetes mellitus (type 1 or type 2).
- At least one eye meets the study eye criteria listed.
- Visual Acuity 20/30 - 20/200 Snellen equivalent
- Have received no previous treatment for diabetic macular edema,(treatment naïve)
Key exclusion criteria (3 listed)
- Have had any prior ocular treatment.
- Have had prior retinal surgical ( i.e. Pars plana vitrectomy). 3 .Have any clinical evidence of proliferative diabetic retinopathy.
- 4. Have a HBA1c of greater of 10%. 5. Evidence of Glaucoma or who are labeled glaucoma suspect at screening (defined as C/D >/= 0.5 with correlated NFLA thinning or IOP>25mmHg). 6. Have a contraindication to Ozurdex.
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 |
|---|---|---|
| Ozurdex Drug Implant ProductAlso: DexamethasoneIntravitreal Ozurdex injection | Drug | Ozurdex Implant |
Primary outcome
Evaluate re perfusion following Ozurdex use.
Time frame: 6 Months
Determined by OCT-A
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
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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.
Diana Shechtman, OD FAAO principal investigator
Retina Macula Specialists of Miami, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ozurdex Drug Implant Product in people with Diabetic Macular Edema and Diabetic Retinopathy, run by Retina Macula Specialists of Miami, LLC at 2 sites 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 8 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: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Shechtman, OD FAAO (954-816-1038, dshehctman@retinamiami.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate re perfusion following Ozurdex use. (time frame: 6 Months). 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 18 Mar 2020.