Diabetes With Diabetic Retinopathy With Macular EdemaICV-DMENCT02639507
International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients
An observational study of Diabetes With Diabetic Retinopathy With Macular Edema, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this research is to evaluate the effectiveness of vitrectomy for the treatment of diabetic macular edema. Diabetes is known to cause retinal blood vessels to leak, leading to swelling of the central retina (macula), and decreased vision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes With Diabetic Retinopathy With Macular Edema
- What is being tested?
- Vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to Mar 2020
- Phase
- Observational
- 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
Study population: Eligible patients will have the following characteristics: * Background diabetic retinopathy. * Center involving macular edema with CST > 325 µm as measured by SD-OCT. * Predominantly intact (80%) ELM and IS/OS lines within 500 µm of the fovea on both horizontal and vertical SD-OCT scans. * Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive
Who may be able to join
- Men and women, > 18 years of age with type 1 or 2 diabetes mellitus diagnosed and treated by an endocrinologist, internist or family medicine physician
- Background diabetic retinopathy
- DME with central subfield thickness (CST) > 325 µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
- HbA1c level of < 10.0 mg/dl
- Previous cataract surgery with implantation of a stable posterior chamber intraocular lens or a phakic eye with 1+ (out of 4+ scale) or less lens opacification
- Predominantly intact (80%) external limiting membrane (ELM) and photoreceptor inner/outer segment (IS/OS) lines within 500 µm of the fovea on horizontal and vertical SD-OCT scans
- Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive.
Who cannot join
- Intraocular anti-vascular endothelial growth factor (VEGF) injection within the previous 3 months
- Systemic anti-VEGF or receptor tyrosine kinase inhibitor therapy within the previous 3 months
- Intraocular corticosteroid injection within the previous 6 months
- Peri-ocular corticosteroid injection within the previous 3 months
- Vitreomacular traction on SD-OCT scan (epiretinal membrane is allowed)
- Previous anterior or pars plana vitrectomy
Show all 12Show fewer
- Glaucoma (IOP of > 21 mmHg or regular use of more than 2 IOP lowering drugs)
- Previous trabeculectomy
- Likelihood of needing intraocular surgery within 6 months
- Hard exudates involving the fovea
- Proliferative diabetic retinopathy with any evidence of retinal traction
- Cataract of grade 2+ or greater.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic in Florida
Jacksonville, Florida, 32224
About this study
Official title: International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients - the ICV-DME Study
The purpose of this research is to evaluate the effectiveness of vitrectomy for the treatment of diabetic macular edema. Diabetes is known to cause retinal blood vessels to leak, leading to swelling of the central retina (macula), and decreased vision. Removing the vitreous gel with vitrectomy surgery is known to decrease the swelling caused by diabetes. Diabetic retinopathy is often treated with laser or injections of medicine in to the eye.
- Being tested
- Vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity
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 posted24 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes With Diabetic Retinopathy With Macular EdemaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael W. Stewart, M.D., Mayo Clinic
- Investigators
- Michael W Stewart, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639507
- Sponsor's protocol ID
- 14-008884
- Acronym
- ICV-DME
- Status last verified
- Mar 2020
- First submitted
- 22 Dec 2015
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients - the ICV-DME Study
- ClinicalTrials.gov ID
- NCT02639507
- Acronym / sponsor ID
- ICV-DME / 14-008884
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 24 Dec 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.
The purpose of this research is to evaluate the effectiveness of vitrectomy for the treatment of diabetic macular edema. Diabetes is known to cause retinal blood vessels to leak, leading to swelling of the central retina (macula), and decreased vision. Removing the vitreous gel with vitrectomy surgery is known to decrease the swelling caused by diabetes. Diabetic retinopathy is often treated with laser or injections of medicine in to the eye.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will have the following characteristics: * Background diabetic retinopathy. * Center involving macular edema with CST > 325 µm as measured by SD-OCT. * Predominantly intact (80%) ELM and IS/OS lines within 500 µm of the fovea on both horizontal and vertical SD-OCT scans. * Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive
Key inclusion criteria (7 listed)
- Men and women, > 18 years of age with type 1 or 2 diabetes mellitus diagnosed and treated by an endocrinologist, internist or family medicine physician
- Background diabetic retinopathy
- DME with central subfield thickness (CST) > 325 µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
- HbA1c level of < 10.0 mg/dl
- Previous cataract surgery with implantation of a stable posterior chamber intraocular lens or a phakic eye with 1+ (out of 4+ scale) or less lens opacification
Key exclusion criteria (12 listed)
- Intraocular anti-vascular endothelial growth factor (VEGF) injection within the previous 3 months
- Systemic anti-VEGF or receptor tyrosine kinase inhibitor therapy within the previous 3 months
- Intraocular corticosteroid injection within the previous 6 months
- Peri-ocular corticosteroid injection within the previous 3 months
- Vitreomacular traction on SD-OCT scan (epiretinal membrane is allowed)
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 |
|---|---|---|
| Vitrectomy | Procedure or surgery | – |
Primary outcome
average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity
Time frame: 6 months
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 26 Mar 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Michael W Stewart, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes With Diabetic Retinopathy With Macular Edema, run by Mayo Clinic 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 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 26 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.
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?
average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity (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 26 Mar 2020.