Macular EdemaLAMEDNCT02650050
Micropulsed Laser in Association With Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).
A study testing Micropulsed laser photocoagulation in people with Macular Edema and Mellitus Diabetes, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Diabetes is a major cause of blindness in adults in the developed countries. The retinal damages associated with diabetes lead to gradual loss of vision, which is accentuated when the macula is affected. This results in macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Mellitus Diabetes
- What is being tested?
- Micropulsed laser photocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2016to 4 Jun 2019
- 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
- 18 years or more
- macular edema associated with a 1 or type 2 diabetes with a hemoglobin A1C level over 5.5% and under <13%
- indication for a treatment with intra-vitreal injections of ranibizumab
Who cannot join
- treatment with anti-VEGF during the previous 2 months
- treatment by intra-vitreous implant of dexamethasone during the previous six months
- previous history of vitrectomy or glaucoma
- photocoagulation during the previous 3 months
- patient's opposition to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Micropulsed Laser in Association With Intravitreal Injections of Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).
Diabetes is a major cause of blindness in adults in the developed countries. The retinal damages associated with diabetes lead to gradual loss of vision, which is accentuated when the macula is affected. This results in macular edema.
Currently, intravitreal injections of anti-VEGF have demonstrated their effectiveness and are the first line treatment of macular edema.
Read more
Subthreshold micropulsed laser photocoagulation is an alternative to conventional grid photocoagulation. By delivering pulsed impacts under the thermal lesion threshold of the pigment epithelium, it would not cause the side effects of conventional photocoagulation. Micropulsed photocoagulation combined to anti-VEGF injections, could be the most effective treatment with a minimum injection number and without epithelial lesions.
The main objective of this study is to show that the subthreshold micropulsed laser photocoagulation, in association with intravitreal injections of anti-VEGF, allows to reduce the number of anti-VEGF injections during the first year of treatment.
In this randomized, double blind study, eligible patients will be randomized between a micropulsed laser photocoagulation arm and a sham micropulsed laser photocoagulation arm.
- Conditions
- Macular Edema, Mellitus Diabetes
- Being tested
- Micropulsed laser photocoagulation
- Medical subject headings
- Macular Edema, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropulsed laser photocoagulationRadiation
Micropulsed laser photocoagulation after 3 anti-VEGF injections
| Study group | Role | What they receive |
|---|---|---|
| Micropulsed laser photocoagulation | Experimental | Not described Receives: Radiation: Micropulsed laser photocoagulation |
| Sham micropulsed laser photocoagulation | Sham comparator | Not described Receives: Radiation: Micropulsed laser photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intra-vitreal anti-VEGF injections
Measured: One year
Secondary outcomes (1)
Time to reduction of the macular thickness
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study start19 Jan 2016
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
Why it stopped: Number of eligible patients too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Georges CAPUTO, Principal investigator, Fondation ophtalmologique de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650050
- Sponsor's protocol ID
- GCO_2015_28
- Acronym
- LAMED
- Status last verified
- Jun 2019
- First submitted
- 7 Jan 2016
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micropulsed Laser in Association With Intravitreal Injections of Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).
- ClinicalTrials.gov ID
- NCT02650050
- Acronym / sponsor ID
- LAMED / GCO_2015_28
- Conditions
- Macular Edema, Mellitus Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Number of eligible patients too low
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 8 Jan 2016 (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.
Diabetes is a major cause of blindness in adults in the developed countries. The retinal damages associated with diabetes lead to gradual loss of vision, which is accentuated when the macula is affected. This results in macular edema.
Currently, intravitreal injections of anti-VEGF have demonstrated their effectiveness and are the first line treatment of macular edema.
Subthreshold micropulsed laser photocoagulation is an alternative to conventional grid photocoagulation. By delivering pulsed impacts under the thermal lesion threshold of the pigment epithelium, it would not cause the side effects of conventional photocoagulation. Micropulsed photocoagulation combined to anti-VEGF injections, could be the most effective treatment with a minimum injection number and without epithelial lesions.
The main objective of this study is to show that the subthreshold micropulsed laser photocoagulation, in association with intravitreal injections of anti-VEGF, allows to reduce the number of anti-VEGF injections during the first year of treatment.
In this randomized, double blind study, eligible patients will be randomized between a micropulsed laser photocoagulation arm and a sham micropulsed laser photocoagulation arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micropulsed laser photocoagulation | Experimental | Radiation: Micropulsed laser photocoagulation |
| Sham micropulsed laser photocoagulation | Sham comparator | Radiation: Micropulsed laser photocoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or more
- macular edema associated with a 1 or type 2 diabetes with a hemoglobin A1C level over 5.5% and under <13%
- indication for a treatment with intra-vitreal injections of ranibizumab
Key exclusion criteria (5 listed)
- treatment with anti-VEGF during the previous 2 months
- treatment by intra-vitreous implant of dexamethasone during the previous six months
- previous history of vitrectomy or glaucoma
- photocoagulation during the previous 3 months
- patient's opposition to participate to the study
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 |
|---|---|---|
| Micropulsed laser photocoagulationMicropulsed laser photocoagulation after 3 anti-VEGF injections | Radiation | Micropulsed laser photocoagulation, Sham micropulsed laser photocoagulation |
Primary outcome
Number of intra-vitreal anti-VEGF injections
Time frame: One year
1 secondary outcome
Time to reduction of the macular thickness
Time frame: One year
Results and safety
The study was stopped early (reason given: Number of eligible patients too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
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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.
Georges CAPUTO principal investigator
Fondation ophtalmologique de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micropulsed laser photocoagulation in people with Macular Edema and Mellitus Diabetes, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 17 Jun 2019. 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 France. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Number of eligible patients too low). Results are not available in the source record.
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?
Number of intra-vitreal anti-VEGF injections (time frame: One 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 17 Jun 2019.