Diabetic Macular EdemaPhase 2UMDMONCT01045239
Micropulse 577 nm Laser Photocoagulation Versus Conventional 532 nm Laser Photocoagulation for Diabetic Macular Oedema
A Phase 2 study testing Micropulse 577 nm yellow diode laser and 532 nm green diode laser in people with Diabetic Macular Edema, run by University of Malaya at 1 site in Malaysia.
Trial summary
The purpose of this study is to determine whether the new micropulse 577 nm yellow laser is a better treatment option compared to the conventional 532 nm green laser for diabetic macular edema. 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 577 nm yellow diode laser and 532 nm green diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2009to Jan 2012
- Phase
- Phase 2
- 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
- Diabetes mellitus (type 1 or 2)
- Diabetic macular edema in study eye associated to diabetic retinopathy
- Diffuse macular edema defined as macular thickening determined by biomicroscopy, OCT and/or fluorescein angiography.
- Best corrected visual acuity between 34 (20/200) and 68 letters (20/50).
- Macular thickness greater than 300 mcm on OCT.
Who cannot join
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
- Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 6 months.
- The following exclusions apply to the study eye only (i.e., they may be present for the nonstudy eye):
- Macular edema is considered to be due to a cause other than diabetic macular edema.
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- Presence of vitreomacular traction.
- Concurrent proliferative diabetic retinopathy.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, significant macular ischemia, nonretinal condition).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis epiretinal membrane, or other ocular inflammatory disease, neovascular glaucoma, etc.).
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
- History of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
- History of panretinal (scatter) photocoagulation (PRP) prior to enrollment or anticipated to be performed within next 6 months.
- History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 12 months or anticipated within the next 6 months.
- History of YAG capsulotomy performed within 2 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Eye Research Centre
Kuala Lumpur, 59100
Ng Joanne, BSc, +603-79494422 ext. 2060, joanne.npj@gmail.com
About this study
Official title: A Randomized, Controlled Trial Comparing Micropulse 577 nm Laser Photocoagulation And Conventional 532 nm Laser Photocoagulation for Diabetic Macular Oedema
The purpose of this study is to determine whether the new micropulse 577 nm yellow laser is a better treatment option compared to the conventional 532 nm green laser for diabetic macular edema.
Read the detailed description
Diabetes mellitus (DM) is a serious debilitating and deadly disease causing significant mortality and morbidity globally. Diabetic macular oedema is the most common cause of visual loss in the working population.
In 1985, the Early Treatment Diabetic Retinopathy Study (ETDRS) demonstrated that focal (direct/grid) laser photocoagulation reduces moderate vision loss from diabetic macular oedema (DMO) by 50% or more. However, further studies have shown that photocoagulation can eventually result in complications leading to loss of central vision and decreased colour vision. Thus, many newer laser machines that claim to reduce the rate of complications have been developed over the years.
In this project, we plan to evaluate the usage of the micropulse 577 nm laser, which is a yellow light laser, and compare it to the conventional 532 nm green laser that is widely used. The 577 nm laser has a high affinity for oxyhemoglobin, a slightly lower affinity for melanin and almost no affinity for macular xanthophylls, as shown in the graph below.22,23,24,25 The yellow 577 nm light also scatters very little and does not cause photochemical reactions in the tissues.
The theoretical advantage of using the micropulse 577 nm yellow laser would be the reduced energy requirement to obtain the same results as with green 532 nm. This leads to less retinal toxicity and damage due to reduced absorption by the xanthophylls. Our aim in this project is to observe whether the theoretical advantage translates to a more effective treatment in reality.
- Conditions
- Diabetic Macular Edema
- Being tested
- Micropulse 577 nm yellow diode laser, 532 nm green diode laser
- Keywords
- Diabetic macular edema, Diabetic macular oedema, micropulse laser, laser treatment, macular thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropulse 577 nm yellow diode laserDevice
Also called Quantel Supra 577nm laser
Laser administered at beginning of study and may be repeated at 16 weeks if needed
532 nm green diode laserDevice
Laser administered at beginning of study and may be repeated at 16 weeks if needed
| Study group | Role | What they receive |
|---|---|---|
| Micropulse 577 nm yellow diode laser | Experimental | Not described Receives: Device: Micropulse 577 nm yellow diode laser |
| 532 nm green diode laser | Active comparator | Not described Receives: Device: 532 nm green diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity by logarithm of the minimum angle of resolution (LogMAR)
Measured: 1 year
Secondary outcomes (2)
Macular thickness measured by optical coherence tomography (OCT)
Measured: 12 months
Photocoagulation scars on fundus photograph
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 posted8 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2011 (estimated)
- Study completionJan 2012 (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.
- More trials run by University of MalayaThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth C Fong, FRCOphth, Principal investigator, University of Malaya Eye Research CentreTajunisah Iqbal, FRCS, Principal investigator, University of Malaya Eye Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045239
- Sponsor's protocol ID
- UMERC001
- Acronym
- UMDMO
- Status last verified
- Jan 2010
- First submitted
- 7 Jan 2010
- Last updated
- 8 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Comparing Micropulse 577 nm Laser Photocoagulation And Conventional 532 nm Laser Photocoagulation for Diabetic Macular Oedema
- ClinicalTrials.gov ID
- NCT01045239
- Acronym / sponsor ID
- UMDMO / UMERC001
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic macular edema, Diabetic macular oedema, micropulse laser, laser treatment, macular thickness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 8 Jan 2010 (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 study is to determine whether the new micropulse 577 nm yellow laser is a better treatment option compared to the conventional 532 nm green laser for diabetic macular edema.
Detailed description
Diabetes mellitus (DM) is a serious debilitating and deadly disease causing significant mortality and morbidity globally. Diabetic macular oedema is the most common cause of visual loss in the working population.
In 1985, the Early Treatment Diabetic Retinopathy Study (ETDRS) demonstrated that focal (direct/grid) laser photocoagulation reduces moderate vision loss from diabetic macular oedema (DMO) by 50% or more. However, further studies have shown that photocoagulation can eventually result in complications leading to loss of central vision and decreased colour vision. Thus, many newer laser machines that claim to reduce the rate of complications have been developed over the years.
In this project, we plan to evaluate the usage of the micropulse 577 nm laser, which is a yellow light laser, and compare it to the conventional 532 nm green laser that is widely used. The 577 nm laser has a high affinity for oxyhemoglobin, a slightly lower affinity for melanin and almost no affinity for macular xanthophylls, as shown in the graph below.22,23,24,25 The yellow 577 nm light also scatters very little and does not cause photochemical reactions in the tissues.
The theoretical advantage of using the micropulse 577 nm yellow laser would be the reduced energy requirement to obtain the same results as with green 532 nm. This leads to less retinal toxicity and damage due to reduced absorption by the xanthophylls. Our aim in this project is to observe whether the theoretical advantage translates to a more effective treatment in reality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micropulse 577 nm yellow diode laser | Experimental | Device: Micropulse 577 nm yellow diode laser |
| 532 nm green diode laser | Active comparator | Device: 532 nm green diode laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes mellitus (type 1 or 2)
- Diabetic macular edema in study eye associated to diabetic retinopathy
- Diffuse macular edema defined as macular thickening determined by biomicroscopy, OCT and/or fluorescein angiography.
- Best corrected visual acuity between 34 (20/200) and 68 letters (20/50).
- Macular thickness greater than 300 mcm on OCT.
Key exclusion criteria (15 listed)
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
- Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 6 months.
- The following exclusions apply to the study eye only (i.e., they may be present for the nonstudy 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 |
|---|---|---|
| Micropulse 577 nm yellow diode laserAlso: Quantel Supra 577nm laserLaser administered at beginning of study and may be repeated at 16 weeks if needed | Device | Micropulse 577 nm yellow diode laser |
| 532 nm green diode laserLaser administered at beginning of study and may be repeated at 16 weeks if needed | Device | 532 nm green diode laser |
Primary outcome
Best corrected visual acuity by logarithm of the minimum angle of resolution (LogMAR)
Time frame: 1 year
2 secondary outcomes
Macular thickness measured by optical coherence tomography (OCT)
Time frame: 12 months
Photocoagulation scars on fundus photograph
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 8 Jan 2010.
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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.
Kenneth C Fong, FRCOphth principal investigator
University of Malaya Eye Research Centre
Tajunisah Iqbal, FRCS principal investigator
University of Malaya Eye Research Centre
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 Micropulse 577 nm yellow diode laser and 532 nm green diode laser in people with Diabetic Macular Edema, run by University of Malaya at 1 site in Malaysia.
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 5 inclusion and 15 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 8 Jan 2010. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Ong, MBBS (+603-79494422 ext. 2060, lindaong@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity by logarithm of the minimum angle of resolution (LogMAR) (time frame: 1 year). 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 8 Jan 2010.