Diabetic Macular EdemaTopcon EMNCT01732614
Topcon Endpoint Management
A study testing Topcon Endpoint Management laser in people with Diabetic Macular Edema, run by Retinal Consultants of Arizona at 1 site in United States.
Trial summary
This trial seeks to prove that sub-lethal laser power levels are as effective and less damaging than traditional laser. Diabetic macular edema (DME) affects approximately 29% of diabetic patients with a disease duration of 20 or more years and is one of the most frequent causes of vision loss in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Topcon Endpoint Management laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2013
- Phase
- Interventional
- 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
- The patient must have macular edema involving the center of the macula with a corresponding leakage on fluorescein angiography.
- Thickening of the fovea of at least 300 microns (thickness of the central point in OCT) with a standard deviation of the center point <10% and signal strength of ≥ 5 OCT ILM and borders (internal limiting membrane) and RPE (retinal pigment epithelium) properly identified. Also, the initial OCT must be confirmed by repeated measurements on the same day, with the thickness of the central point being within 10% between measurements. In cases where the OCT imaging program can not properly define the limits of ILM and RPE, if the investigator can obtain an estimate of the thickness of the manual by OCT central point of at least 300 microns, the patient will be considered eligible.
- The distance visual acuity in the better eye corrected the study must have an index between 70 and 35 letters inclusive (Snellen equivalent of 20/40 to 20/200).
- Clear media and eye pupil dilation adequate to allow fundus photography with good quality.
- Intraocular pressure not exceeding 21 mmHg.
- The ophthalmologist should feel comfortable with the delay of the focal laser treatment (direct and grid, as needed) by at least 12 weeks in the study eye.
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- Patients with diabetes Type I or Type II as defined by WHO criteria of any gender and age ≥ 18 years.
- Ability to provide a written consent.
- Ability to return for all study visits.
Who cannot join
- Eyes with scatter photocoagulation (PRP) one month prior the enrollment, or eyes where scatter photocoagulation is required now, or it likely to be needed over the next 6months (for example, eyes with high risk PDR DRS not properly treated with photocoagulation).
- Presence of any abnormality that is likely to confound the assessment of the improvement in visual acuity in eyes with macular edema to resolve or improve as an area of hard exudates involving the foveal avascular zone (FAZ - involving 2 or more quadrants centered around the foveal avascular zone), epiretinal membrane associated with signs of contraction and / or significant opacification (ie, striations within the diameter of a disc from the center of the fovea), or the presence of chorioretinal atrophy involving the center of the macula.
- Vitreomacular traction determined clinically and / or OCT, which in the opinion of the investigator, contributes to macular edema (associated or cause a detachment of the fovea) and prevents the improvement with treatment.
- Any cause of macular edema other than DME.
- Atrophy / scar / fibrosis involving the center of the macula, including evidence of atrophy treated with laser within 200 microns of the FAZ.
- Patients who received panphotocoagulation, YAG laser, or peripheral retinal cryoablation (for retinal tears) or focal or grid photocoagulation within the last 12 weeks or more of treatment with focal or grid laser.
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- Significant opacities of the optical medium, including cataracts, which may interfere with visual acuity, assessment of toxicity or photography background. Patients will not be included if they have high probability of requiring cataract surgery within the next year.
- Any intraocular surgery within 6 months prior to study entry.
- Prior peeling of epiretinal membrane or inner limiting membrane.
- Any major surgical procedure within one month of study entry
- Prior irradiation of the head region of the eye under study.
- Any previous pharmacological treatment for DME (including corticosteroid intravitreal, subconjunctival or subtenon) or at any time during the last 90 days for any other condition.
- Important known allergies to sodium fluorescein dye used in angiography.
- Acute ocular or periocular infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Retinal Consultants of Arizona
Phoenix, Arizona, 85014
About this study
Official title: Safety Assessment and Therapeutic Effect of Non-damaging Patterned Scanning Laser Phototherapy in Patients With Diffuse Diabetic Macular Edema
This trial seeks to prove that sub-lethal laser power levels are as effective and less damaging than traditional laser. Diabetic macular edema (DME) affects approximately 29% of diabetic patients with a disease duration of 20 or more years and is one of the most frequent causes of vision loss in this population. The Early Treatment Diabetic Retinopathy Study (ETDRS) demonstrated a significant benefit of laser photocoagulation for the treatment of clinically significant macular edema, reducing the incidence of vision loss by approximately 50% at 3 years' follow-up.
Read the detailed description
Sub-visible, non-damaging visible laser (532 nm) exposures of 100 ms in duration resulted in enhanced expression of heat shock proteins in the retina. To test clinical efficacy of sub-visible retinal therapy using ms-range exposures of visible lasers one needs first to establish proper titration methods necessary to assure on one hand the lack of tissue damage, and on the other hand sufficient hyperthermia to elicit cellular response.
- Conditions
- Diabetic Macular Edema
- Being tested
- Topcon Endpoint Management laser
- Keywords
- Diabetic Macular Edema, DME, Laser, Topcon, EndPoint Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topcon Endpoint Management laserProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Topcon Endpoint Management Laser | Experimental | Not described Receives: Procedure: Topcon Endpoint Management laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Visual acuity
Improvement in visual acuity > 10 letters or two lines in the ETDRS chart
Measured: 12 months
Reduction of the central macular thickness by SD-OCT
Reduction of the central macular thickness by SD-OCT
Measured: 12 months
Secondary outcomes (1)
Cessation of leakage areas on FA
Use of fluorescein angiography to assess leakage and identify laser burn
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2013
- Study completionDec 2013
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retinal Consultants of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Topcon Corporation
- Responsible party
- Sponsor
- Investigators
- Pravin U Dugel, MD, Principal investigator, Retinal Consultants of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732614
- Sponsor's protocol ID
- Topcon Endpoint Management
- Acronym
- Topcon EM
- Status last verified
- Mar 2014
- First submitted
- 14 Nov 2012
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment and Therapeutic Effect of Non-damaging Patterned Scanning Laser Phototherapy in Patients With Diffuse Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01732614
- Acronym / sponsor ID
- Topcon EM / Topcon Endpoint Management
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, DME, Laser, Topcon, EndPoint Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Retinal Consultants of ArizonaUniversity, hospital or other
- Collaborators
- Topcon Corporation
- Study start
- Aug 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Nov 2012 (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.
This trial seeks to prove that sub-lethal laser power levels are as effective and less damaging than traditional laser. Diabetic macular edema (DME) affects approximately 29% of diabetic patients with a disease duration of 20 or more years and is one of the most frequent causes of vision loss in this population. The Early Treatment Diabetic Retinopathy Study (ETDRS) demonstrated a significant benefit of laser photocoagulation for the treatment of clinically significant macular edema, reducing the incidence of vision loss by approximately 50% at 3 years' follow-up.
Detailed description
Sub-visible, non-damaging visible laser (532 nm) exposures of 100 ms in duration resulted in enhanced expression of heat shock proteins in the retina. To test clinical efficacy of sub-visible retinal therapy using ms-range exposures of visible lasers one needs first to establish proper titration methods necessary to assure on one hand the lack of tissue damage, and on the other hand sufficient hyperthermia to elicit cellular response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topcon Endpoint Management Laser | Experimental | Procedure: Topcon Endpoint Management laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient must have macular edema involving the center of the macula with a corresponding leakage on fluorescein angiography.
- Thickening of the fovea of at least 300 microns (thickness of the central point in OCT) with a standard deviation of the center point <10% and signal strength of ≥ 5 OCT ILM and borders (internal limiting membrane) and RPE (retinal pigment epithelium) properly identified. Also, the initial OCT must be confirmed by repeated measurements on the same day, with the thickness of the central point being within 10% between measurements. In cases where the OCT imaging program can not properly define the limits of ILM and RPE, if the investigator can obtain an estimate of the thickness of the manual by OCT central point of at least 300 microns, the patient will be considered eligible.
- The distance visual acuity in the better eye corrected the study must have an index between 70 and 35 letters inclusive (Snellen equivalent of 20/40 to 20/200).
- Clear media and eye pupil dilation adequate to allow fundus photography with good quality.
- Intraocular pressure not exceeding 21 mmHg.
Key exclusion criteria (14 listed)
- Eyes with scatter photocoagulation (PRP) one month prior the enrollment, or eyes where scatter photocoagulation is required now, or it likely to be needed over the next 6months (for example, eyes with high risk PDR DRS not properly treated with photocoagulation).
- Presence of any abnormality that is likely to confound the assessment of the improvement in visual acuity in eyes with macular edema to resolve or improve as an area of hard exudates involving the foveal avascular zone (FAZ - involving 2 or more quadrants centered around the foveal avascular zone), epiretinal membrane associated with signs of contraction and / or significant opacification (ie, striations within the diameter of a disc from the center of the fovea), or the presence of chorioretinal atrophy involving the center of the macula.
- Vitreomacular traction determined clinically and / or OCT, which in the opinion of the investigator, contributes to macular edema (associated or cause a detachment of the fovea) and prevents the improvement with treatment.
- Any cause of macular edema other than DME.
- Atrophy / scar / fibrosis involving the center of the macula, including evidence of atrophy treated with laser within 200 microns of the FAZ.
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 |
|---|---|---|
| Topcon Endpoint Management laser | Procedure or surgery | Topcon Endpoint Management Laser |
Primary outcome
Changes in Visual acuity
Time frame: 12 months
Improvement in visual acuity > 10 letters or two lines in the ETDRS chart
Reduction of the central macular thickness by SD-OCT
Time frame: 12 months
Reduction of the central macular thickness by SD-OCT
1 secondary outcome
Cessation of leakage areas on FA
Time frame: 12 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 20 Mar 2014.
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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.
Pravin U Dugel, MD principal investigator
Retinal Consultants of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topcon Endpoint Management laser in people with Diabetic Macular Edema, run by Retinal Consultants of Arizona 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 9 inclusion and 14 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 20 Mar 2014. 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.
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?
Changes in Visual acuity (time frame: 12 months). 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 20 Mar 2014.