Diabetic RetinopathyPhase 4NCT04359771
Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema
A Phase 4 study testing Yellow micro-pulse laser and Diode micro-pulse laser in people with Diabetic Retinopathy and Macula Edema, run by Cairo University at 1 site in Egypt.
Trial summary
Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need of repeated injections, which carries both economic and compliance problems to the patients.there is a growing evidence that… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetic Retinopathy, Macula Edema
- What is being tested?
- Yellow micro-pulse laser and Diode micro-pulse laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2018to 25 Sep 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral diabetic macular edema
- center involving confirmed by Optical coherence tomogram (OCT)
Who cannot join
- any non-diabetic macular edema
- significant media opacities
- previous laser treatment, any intraocular surgery within the past 6 months
- previous intravitreal injections of any drug within the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yellow Micropulse Laser 577-nm vs Infrared Diode Micropulse Laser 810-nm for the Treatment of Diabetic Macular Edema
Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need of repeated injections, which carries both economic and compliance problems to the patients.there is a growing evidence that recognises the effectiveness of the use of micropulse laser (MPL) in treatment of DME. with MPL, it is possible to deliver a subthreshold laser that is above the threshold of biochemical effect but below the threshold of a visible, destructive lesion thereby preventing collateral damage.The MPL technique is available at near - infrared 810 nm diode laser (diode MPL) and at 577 nm (yellow MPL). The current study was conducted in order to compare the efficacy of both MPL techniques in the treatment of center involving DME.
Read the detailed description
This was a prospective randomized comparative study that included 30 eyes of 15 patients with bilateral DME. The patients were recruited from the Retina Clinic at Kasr Al Ainy Hospital, Cairo University. The study's protocol was reviewed and approved by board of the ophthalmology department, Cairo University, and was in concordance with the tents of Declaration of Helsinki. Eligible patients were informed about the study's objectives, methodology, risks and benefits. A written informed consent was obtained from every patient included in this study.Preliminary examination was in the form of slit-lamp examination, fundus examination, intra ocular pressure measurement, and best corrected visual acuity (BCVA) measurement. A spectral domain optical coherence tomogram (OCT) scan was performed to all patients before treatment to measure the central retinal thickness (CRT). The eyes were randomized into two groups; one eye (right eye) of each patient was treated with 577-nm yellow MPL and the other eye (left eye) of the same patient with Infrared 810-nm diode MPL. Changes in the BCVA and CRT were measured after treatment at 1 and 3 months of follow up.
- Conditions
- Diabetic Retinopathy, Macula Edema
- Being tested
- Yellow micro-pulse laser, Diode micro-pulse laser
- Keywords
- micro-pulse laser, trans-foveal
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yellow micro-pulse laserDevice
applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea
Diode micro-pulse laserDevice
applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
| Study group | Role | What they receive |
|---|---|---|
| Yellow MPL | Active comparator | Not described Receives: Device: Yellow micro-pulse laser |
| Diode MPL | Active comparator | Not described Receives: Device: Diode micro-pulse laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Central Retinal Thickness (CRT)
detecting changes in the thickness of the center of the macula
Measured: baseline, at 1 month and 3 months after the intervention
Change in the Best Corrected Visual Acuity (BCVA)
detecting changes in the the best corrected visual acuity in logMAR. A LogMAR chart comprises rows of letters and is used by ophthalmologists, optometrists and vision scientists to estimate visual acuity. This chart was developed at the National Vision Research Institute of Australia in 1976, and is designed to enable a more accurate estimate of acuity than do other charts (e.g., the Snellen chart). For this reason, the LogMAR chart is recommended, particularly in a research setting. A Snellen score of 6/6 (20/20), indicating that an observer can resolve details as small as 1 minute of visual angle, corresponds to a LogMAR of 0 (since the base-10 logarithm of 1 is 0); a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small as 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is near-approximately 0.3), and so on.Therefore, a higher logMAR scores mean a worse outcome.
Measured: baseline, at 1 month and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start22 Jan 2018
- Primary completion25 Sep 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelbaki, Cairo University
- Investigators
- Hany S Hamza, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359771
- Sponsor's protocol ID
- I-030416
- Status last verified
- May 2020
- First submitted
- 21 Apr 2020
- Last updated
- 1 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Vujosevic S, Martini F, Longhin E, Convento E, Cavarzeran F, Midena E. SUBTHRESHOLD MICROPULSE YELLOW LASER VERSUS SUBTHRESHOLD MICROPULSE INFRARED LASER IN CENTER-INVOLVING DIABETIC MACULAR EDEMA: Morphologic and Functional Safety. Retina. 2015 Aug;35(8):1594-603. doi: 10.1097/IAE.0000000000000521.
PubMed 25719988Scholz P, Altay L, Fauser S. A Review of Subthreshold Micropulse Laser for Treatment of Macular Disorders. Adv Ther. 2017 Jul;34(7):1528-1555. doi: 10.1007/s12325-017-0559-y. Epub 2017 May 24.
PubMed 28540655
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yellow Micropulse Laser 577-nm vs Infrared Diode Micropulse Laser 810-nm for the Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT04359771
- Acronym / sponsor ID
- I-030416
- Conditions
- Diabetic Retinopathy, Macula Edema
- Keywords
- micro-pulse laser, trans-foveal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Posted 1 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need of repeated injections, which carries both economic and compliance problems to the patients.there is a growing evidence that recognises the effectiveness of the use of micropulse laser (MPL) in treatment of DME. with MPL, it is possible to deliver a subthreshold laser that is above the threshold of biochemical effect but below the threshold of a visible, destructive lesion thereby preventing collateral damage.The MPL technique is available at near - infrared 810 nm diode laser (diode MPL) and at 577 nm (yellow MPL). The current study was conducted in order to compare the efficacy of both MPL techniques in the treatment of center involving DME.
Detailed description
This was a prospective randomized comparative study that included 30 eyes of 15 patients with bilateral DME. The patients were recruited from the Retina Clinic at Kasr Al Ainy Hospital, Cairo University. The study's protocol was reviewed and approved by board of the ophthalmology department, Cairo University, and was in concordance with the tents of Declaration of Helsinki. Eligible patients were informed about the study's objectives, methodology, risks and benefits. A written informed consent was obtained from every patient included in this study.Preliminary examination was in the form of slit-lamp examination, fundus examination, intra ocular pressure measurement, and best corrected visual acuity (BCVA) measurement. A spectral domain optical coherence tomogram (OCT) scan was performed to all patients before treatment to measure the central retinal thickness (CRT). The eyes were randomized into two groups; one eye (right eye) of each patient was treated with 577-nm yellow MPL and the other eye (left eye) of the same patient with Infrared 810-nm diode MPL. Changes in the BCVA and CRT were measured after treatment at 1 and 3 months of follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yellow MPL | Active comparator | Device: Yellow micro-pulse laser |
| Diode MPL | Active comparator | Device: Diode micro-pulse laser |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- bilateral diabetic macular edema
- center involving confirmed by Optical coherence tomogram (OCT)
Key exclusion criteria (4 listed)
- any non-diabetic macular edema
- significant media opacities
- previous laser treatment, any intraocular surgery within the past 6 months
- previous intravitreal injections of any drug within the past 6 months
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 |
|---|---|---|
| Yellow micro-pulse laserapplying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea | Device | Yellow MPL |
| Diode micro-pulse laserapplying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea | Device | Diode MPL |
Primary outcome
Change in Central Retinal Thickness (CRT)
Time frame: baseline, at 1 month and 3 months after the intervention
detecting changes in the thickness of the center of the macula
Change in the Best Corrected Visual Acuity (BCVA)
Time frame: baseline, at 1 month and 3 months after the intervention
detecting changes in the the best corrected visual acuity in logMAR. A LogMAR chart comprises rows of letters and is used by ophthalmologists, optometrists and vision scientists to estimate visual acuity. This chart was developed at the National Vision Research Institute of Australia in 1976, and is designed to enable a more accurate estimate of acuity than do other charts (e.g., the Snellen chart). For this reason, the LogMAR chart is recommended, particularly in a research setting. A Snellen score of 6/6 (20/20), indicating that an observer can resolve details as small as 1 minute of visual angle, corresponds to a LogMAR of 0 (since the base-10 logarithm of 1 is 0); a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small as 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is near-approximately 0.3), and so on.Therefore, a higher logMAR scores mean a worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25719988Vujosevic S, Martini F, Longhin E, Convento E, Cavarzeran F, Midena E. SUBTHRESHOLD MICROPULSE YELLOW LASER VERSUS SUBTHRESHOLD MICROPULSE INFRARED LASER IN CENTER-INVOLVING DIABETIC MACULAR EDEMA: Morphologic and Functional Safety. Retina. 2015 Aug;35(8):1594-603. doi: 10.1097/IAE.0000000000000521.
- Background: PubMed 28540655Scholz P, Altay L, Fauser S. A Review of Subthreshold Micropulse Laser for Treatment of Macular Disorders. Adv Ther. 2017 Jul;34(7):1528-1555. doi: 10.1007/s12325-017-0559-y. Epub 2017 May 24.
- Individual participant dataSharing planned: Yes
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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.
Hany S Hamza, MD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yellow micro-pulse laser and Diode micro-pulse laser in people with Diabetic Retinopathy and Macula Edema, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 4 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 1 Jun 2020. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Central Retinal Thickness (CRT) (time frame: baseline, at 1 month and 3 months after the intervention). 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?
On the ClinicalTrials.gov record for NCT04359771, which also lists 2 linked publications.
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 1 Jun 2020.