Diabetic Macular EdemaNCT01928654
Comparison Between Treatment With Yellow Micropulse Laser and Green Conventional Laser in Diabetic Macular Edema
A study testing Micropulse laser treatment and Laser modified ETDRS in people with Diabetic Macular Edema, run by Luigi Sacco University Hospital at 1 site in Italy.
Trial summary
Macular edema is the most important cause of visual impairment in diabetic patients. Intravitreal injections of antiVEGF (vascular endothelial growth factor) agents and laser treatment are two effective therapies for stabilising visual acuity. 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?
- Micropulse laser treatment and Laser modified ETDRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2013to Nov 2014
- 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
- written informed consent prior to study entry
- male or female patients >= 18 years of age
- patients with diagnosis of diabetes type 1 or 2 and clinically significant macular edema
- visual impairment due to clinically significant diabetic macular edema
- best-corrected visual acuity included between 21 and 74 ETDRS letters
- central retinal thickness greater than 320 micron (Spectralis SD-OCT, Heidelberg Engineering, Germany)
- leakage and/or micro aneurysm in fluorescein angiography images within the area of retinal thickening
- HbA1C ≤10% with well-controlled blood pressure and renal function
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Eye Clinic - Luigi Sacco University Hospital
Milan, 20157
Andrea Giani, MD, +39023904 ext. 2901, andrea.giani@unimi.it
Antonio Caimi, MD, +39023904 ext. 2441, antonio.caimi@gmail.com
About this study
Macular edema is the most important cause of visual impairment in diabetic patients. Intravitreal injections of antiVEGF (vascular endothelial growth factor) agents and laser treatment are two effective therapies for stabilising visual acuity. However, antiVEGF therapy is very expensive and potentially needs to to be repeated for all patients life. Laser treatment, according to modified ETDRS (early treatment diabetic retinopathy study), produces retinal burns with possible negative consequences such as alterations in the visual fields.
With micropulse treatment modality laser energy is delivered in short pulses ("micropulses") rather than as a continuous wave. In this way the amount of energy delivered to the retina and retinal pigment epithelium (RPE) is significantly reduced. This finer control of the photothermal effects should avoid any retinal and RPE damage. At the same time, according to several published reports, the efficacy of treatment appears to be equivalent to conventional laser therapy.
Previous studies investigated the effects of 810nm micropulse laser therapy. Recently, this treatment modality has been made available also with 577nm wavelength, which corresponds to the maximum absorption level for blood. Aim of this study is to assess the safety and efficacy of 577nm micropulse laser treatment compared to conventional modified ETDRS laser therapy.
- Conditions
- Diabetic Macular Edema
- Being tested
- Micropulse laser treatment, Laser modified ETDRS
- Keywords
- Edema, Diabetic, Laser, Treatment
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropulse laser treatmentDevice
Device for subthreshold treatment of the retina, by decomposing a continuos wave of laser in micropulses, with 5% duty cycle, 200 milliseconds, 100 microns, and power adjusted according to patient's diopter transparency and pigmentation.
Laser modified ETDRSDevice
Device for visible treatment of the retina, with direct treatment of microaneurysms or grid pattern covering the area of retinal edema.
| Study group | Role | What they receive |
|---|---|---|
| Micropulse laser treatment | Experimental | Sub-threshold laser treatment covering the area of retinal thickening with a dense pattern Receives: Device: Micropulse laser treatment |
| Laser modified ETDRS | Active comparator | Macular treatment using the modified ETDRS protocol, with barely visible laser burns to close microaneurysms, or with a grid pattern in the area of retinal thickening. Receives: Device: Laser modified ETDRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in visual acuity (ETDRS letters)
Measured: 12 months
Secondary outcomes (3)
Mean change in central retinal thickness
Central retinal thickness corresponds to the mean retinal thickness within the 1-mm central subfield centred on the fovea. This measurement is obtained with Spectralis spectral-domain optical coherence tomography (SD-OCT) (Heidelberg Engineering, Germany).
Measured: 12 months
Percentage of patients gaining ETDRS lines
Percentage of patients that gain 1, 2, or 3 ETDRS lines of visual acuity
Measured: 12 months
Percentage of patients losing ETDRS lines
PErcentage of patients that loose 1, 2, or 3 ETDRS lines of visual acuity
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 posted27 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2014 (estimated)
- Study completionNov 2014 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luigi Sacco University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Staurenghi, Luigi Sacco University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928654
- Sponsor's protocol ID
- Lasercomparison
- Status last verified
- Mar 2014
- First submitted
- 21 Aug 2013
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Treatment With Yellow Micropulse Laser and Green Conventional Laser in Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01928654
- Acronym / sponsor ID
- Lasercomparison
- Conditions
- Diabetic Macular Edema
- Keywords
- Edema, Diabetic, Laser, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Luigi Sacco University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 27 Aug 2013 (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.
Macular edema is the most important cause of visual impairment in diabetic patients. Intravitreal injections of antiVEGF (vascular endothelial growth factor) agents and laser treatment are two effective therapies for stabilising visual acuity. However, antiVEGF therapy is very expensive and potentially needs to to be repeated for all patients life. Laser treatment, according to modified ETDRS (early treatment diabetic retinopathy study), produces retinal burns with possible negative consequences such as alterations in the visual fields.
With micropulse treatment modality laser energy is delivered in short pulses ("micropulses") rather than as a continuous wave. In this way the amount of energy delivered to the retina and retinal pigment epithelium (RPE) is significantly reduced. This finer control of the photothermal effects should avoid any retinal and RPE damage. At the same time, according to several published reports, the efficacy of treatment appears to be equivalent to conventional laser therapy.
Previous studies investigated the effects of 810nm micropulse laser therapy. Recently, this treatment modality has been made available also with 577nm wavelength, which corresponds to the maximum absorption level for blood. Aim of this study is to assess the safety and efficacy of 577nm micropulse laser treatment compared to conventional modified ETDRS laser therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micropulse laser treatment | Experimental | Device: Micropulse laser treatmentSub-threshold laser treatment covering the area of retinal thickening with a dense pattern |
| Laser modified ETDRS | Active comparator | Device: Laser modified ETDRSMacular treatment using the modified ETDRS protocol, with barely visible laser burns to close microaneurysms, or with a grid pattern in the area of retinal thickening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- written informed consent prior to study entry
- male or female patients >= 18 years of age
- patients with diagnosis of diabetes type 1 or 2 and clinically significant macular edema
- visual impairment due to clinically significant diabetic macular edema
- best-corrected visual acuity included between 21 and 74 ETDRS letters
Key exclusion criteria (1 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 |
|---|---|---|
| Micropulse laser treatmentDevice for subthreshold treatment of the retina, by decomposing a continuos wave of laser in micropulses, with 5% duty cycle, 200 milliseconds, 100 microns, and power adjusted according to patient's diopter transparency and pigmentation. | Device | Micropulse laser treatment |
| Laser modified ETDRSDevice for visible treatment of the retina, with direct treatment of microaneurysms or grid pattern covering the area of retinal edema. | Device | Laser modified ETDRS |
Primary outcome
Mean change in visual acuity (ETDRS letters)
Time frame: 12 months
3 secondary outcomes
Mean change in central retinal thickness
Time frame: 12 months
Percentage of patients gaining ETDRS lines
Time frame: 12 months
Percentage of patients losing ETDRS lines
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micropulse laser treatment and Laser modified ETDRS in people with Diabetic Macular Edema, run by Luigi Sacco University Hospital at 1 site in Italy.
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 1 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 19 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Giani, MD (+39023904 ext. 2901, andrea.giani@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in visual acuity (ETDRS letters) (time frame: 12 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 19 Mar 2014.