Diabetic Macular EdemaPhase 2NCT00552435
Micropulse 810 Nanomolar (nm), Diode Laser for Diffuse Diabetic Macular Edema
A Phase 2 study testing Laser photocoagulation in people with Diabetic Macular Edema, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Objective: To compare micropulse 810nm diode laser photocoagulation versus argon laser photocoagulation for treatment of diabetic macular edema. Micropulse laser technique will be determined by an initial clinical trial comparing single versus double density laser photocoagulation techniques for treatment of diabetic… 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?
- Laser photocoagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2007to Nov 2008
- 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 and 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
- Uncontrolled systemic disease
- Start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit.
- HbA1c levels greater than 10%
- Presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema.
- Presence of epiretinal membrane
- Presence of vitreomacular traction in the study eye.
Show all 13Show fewer
- Neovascularization of disc or elsewhere in the study eye.
- History or presence of choroidal neovascularization in the study eye.
- Presence of rubeosis irides in the study eye.
- Eye opacity that interfere with clinical documentation and photography.
- Intra-ocular surgery 90 days before initial visit.
- Scheduled surgery for study eye.
- Patients with known allergies to fluorescein.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Vision Institute, Federal University of Sao Paulo
São Paulo, São Paulo
Daniel Lavinsky, MD, 55-11-7658-8669
Jose A Cardillo
About this study
Official title: Phase 2 Study of Micropulse 810nm Diode Laser Photocoagulation for Treatment of Diffuse Diabetic Macular Edema
Objective: To compare micropulse 810nm diode laser photocoagulation versus argon laser photocoagulation for treatment of diabetic macular edema. Micropulse laser technique will be determined by an initial clinical trial comparing single versus double density laser photocoagulation techniques for treatment of diabetic macular edema.The single density is based on the Early Treatment Diabetic Retinopathy Study (ETDRS) grid photocoagulation technique and the double density increases the number of spots.
Methods: Patients with diabetic macular edema will be assigned to receive either micropulse 810nm diode laser photocoagulation or argon laser photocoagulation therapy. First, in a smaller clinical trial, patients will be assigned to single or double density micropulse 810nm diode laser to determine best strategy for this therapy. Visual acuity, fundus photographs and fluorescein angiography, and optical coherence tomography measurements , autofluorescence and mfERG were obtained at baseline and at 1, 3 and 6 months and 12 months.
- Conditions
- Diabetic Macular Edema
- Being tested
- Laser photocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser photocoagulationDevice
Laser therapy is applied using a slit lamp and specific laser contact lens.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Micropulse 810nm diode laser Receives: Device: Laser photocoagulation |
| 2 | Active comparator | Argon laser photocoagulation Receives: Device: Laser photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular thickness measured by optical coherence tomography (OCT)
Measured: 12 months
Secondary outcomes (2)
Safety profile
Measured: 12 months
Selectivity of laser therapy (autofluorescence and mfERG)
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 posted2 Nov 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Jose A Cardillo, Principal investigator, Federal University of Sao Paulo- Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552435
- Sponsor's protocol ID
- MP-001
- Status last verified
- May 2008
- First submitted
- 31 Oct 2007
- Last updated
- 7 May 2008
- Results posted
- No
Publications
Lavinsky D, Cardillo JA, Melo LA Jr, Dare A, Farah ME, Belfort R Jr. Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Jun 17;52(7):4314-23. doi: 10.1167/iovs.10-6828.
PubMed 21345996
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Micropulse 810nm Diode Laser Photocoagulation for Treatment of Diffuse Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00552435
- Acronym / sponsor ID
- MP-001
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 2 Nov 2007 (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.
Objective: To compare micropulse 810nm diode laser photocoagulation versus argon laser photocoagulation for treatment of diabetic macular edema. Micropulse laser technique will be determined by an initial clinical trial comparing single versus double density laser photocoagulation techniques for treatment of diabetic macular edema.The single density is based on the Early Treatment Diabetic Retinopathy Study (ETDRS) grid photocoagulation technique and the double density increases the number of spots.
Methods: Patients with diabetic macular edema will be assigned to receive either micropulse 810nm diode laser photocoagulation or argon laser photocoagulation therapy. First, in a smaller clinical trial, patients will be assigned to single or double density micropulse 810nm diode laser to determine best strategy for this therapy. Visual acuity, fundus photographs and fluorescein angiography, and optical coherence tomography measurements , autofluorescence and mfERG were obtained at baseline and at 1, 3 and 6 months and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Laser photocoagulationMicropulse 810nm diode laser |
| 2 | Active comparator | Device: Laser photocoagulationArgon laser photocoagulation |
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 and 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 (13 listed)
- Uncontrolled systemic disease
- Start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit.
- HbA1c levels greater than 10%
- Presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema.
- Presence of epiretinal membrane
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 |
|---|---|---|
| Laser photocoagulationLaser therapy is applied using a slit lamp and specific laser contact lens. | Device | 1, 2 |
Primary outcome
Macular thickness measured by optical coherence tomography (OCT)
Time frame: 12 months
2 secondary outcomes
Safety profile
Time frame: 12 months
Selectivity of laser therapy (autofluorescence and mfERG)
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 7 May 2008.
- Derived from this study: PubMed 21345996Lavinsky D, Cardillo JA, Melo LA Jr, Dare A, Farah ME, Belfort R Jr. Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Jun 17;52(7):4314-23. doi: 10.1167/iovs.10-6828.
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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.
Jose A Cardillo principal investigator
Federal University of Sao Paulo- Department of Ophthalmology
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 Laser photocoagulation in people with Diabetic Macular Edema, run by Federal University of São Paulo at 1 site in Brazil.
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 13 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 7 May 2008. 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 Brazil. 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 Daniel Lavinsky (55-11-7658-8669, lavinsky@via-rs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular thickness measured by optical coherence tomography (OCT) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552435, which also lists 1 linked publication.
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 7 May 2008.