Diabetic Macular EdemaPULSENCT03519581
Micropulse for Suppression of Diabetic Macular Edema
A study testing Micropulse Laser Treatment in people with Diabetic Macular Edema, run by University of California, Davis at 1 site in United States.
Trial summary
Diabetic retinopathy is one of the most common complications of diabetes and diabetic macular edema (DME) is one of the most common causes of vision loss in diabetes. The purpose of this study is to determine if early intervention with micropulse laser treatment in eyes with good visual acuity (20/32 or better) will… 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2018to 31 Jan 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years
- Type 1 or type 2 diabetes mellitus
- Clinical evidence of center-involved DME confirmed on OCT, and defined by OCT
- Central Subfield (CSF) thickness at the time of randomization by the following:
- Zeiss Cirrus: 275μ in women, and 290μ in men
- Heidelberg Spectralis: 290μ in women, and 305μ in men
- Best corrected visual acuity of 20/32 or better on ETDRS testing
Who cannot join
- Macular edema from causes other than DME
- An ocular condition is present such that in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (i.e/foveal atrophy, pigment abnormalities, dense hard exudates)
- An ocular condition is present other than DME which may contribute to macular edema (i.e/vein occlusion, ERM, uveitis, RP, etc…).
- Cataract that in the opinion of the investigator may alter visual acuity throughout the course of the study
- History of prior laser or other surgical, intravitreal, or peribulbar treatment for DME in the study eye within the prior 6 months.
- More than 4 prior intraocular injections for treatment of DME at any time
Show all 14Show fewer
- More than 1 prior focal/grid macular photocoagulation session for treatment of DME at any time
- History of topical steroid or NSAID treatment within 30 days prior to randomization
- History of PRP within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization.
- Any history of vitrectomy.
- History of major ocular surgery (cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization
- History of YAG capsulotomy performed within 2 months prior to randomization.
- Aphakia
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
Diabetic retinopathy is one of the most common complications of diabetes and diabetic macular edema (DME) is one of the most common causes of vision loss in diabetes.
The purpose of this study is to determine if early intervention with micropulse laser treatment in eyes with good visual acuity (20/32 or better) will improve or stabilize vision loss due to the complications of diabetic macular edema.
Read the detailed description
This is a randomized, controlled clinical trial comparing subthreshold micropulse laser versus sham laser treatment for eyes with diabetic macular edema with good visual acuity of 20/32 or better.
Subjects will be randomized to receive either subthreshold micropulse laser treatment or no treatment (sham). Randomization will occur as a ratio of 2:1 and will take place during the clinic visit.
Subjects selected for the study will undergo a complete ophthalmic examination, including measurements of best corrected visual acuity, low luminance visual acuity, contrast sensitivity (using ETDRS testing with a masked coordinator), intraocular pressure, slit lamp exam including documentation of lens status, and dilated funduscopic exam with standard dilating agents used at the UC Davis Eye Center. Subjects will then undergo baseline imaging including Spectral Domain Ocular Coherence Tomography (SD-OCT), fundus autofluorescence (FAF) and microperimetry testing. Both the use of OCT, FAF, and microperimetry testing are within the standard of care for the management of DME.
The duration of an individual subject's participation in the study will be two years which will include at least 10 total visits at various time points including on the day of enrollment, followed by 1, 3, 6, 9, and 12, 15, 18, 21, 24 months after the day of enrollment.
The subjects in the treatment arm will be treated on the day of randomization by SML photocoagulation using the Iridex IQ577 laser unit with TxCell scanning laser delivery system.
Subjects in the sham treatment arm will undergo the same set up procedures as those receiving the laser treatment, however, no actual laser treatment will occur.
Subjects will then return to the clinic for repeat ophthalmic exam, OCT imaging, and microperimetry at 1 month, 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month and 24 month time points, which is similar in frequency as standard of care.
Patients in the treatment arm are eligible for repeat SML laser at any subsequent visit if there is any decline in vision (1 or more ETDRS lines) or worsening in edema (>10% increase), at the discretion of the treating physician. If vision declines to 20/40 or worse at any study visit, patients in the treatment arm will undergo repeat treatment with SML laser, while those in the sham arm will undergo repeat sham laser.
- Conditions
- Diabetic Macular Edema
- Being tested
- Micropulse Laser Treatment, Sham Treatment
- Keywords
- DME, micropulse laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropulse Laser TreatmentDevice
Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea.
Sham TreatmentDevice
Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
| Study group | Role | What they receive |
|---|---|---|
| Micropulse Laser Treatment | Active comparator | Subjects assigned to the micropulse laser arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea. Receives: Device: Micropulse Laser Treatment |
| Sham Treatment | Placebo comparator | Subjects assigned to the sham arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. No Actual laser treatment will occur Receives: Device: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Vision Loss to 20/40 or Worse
BCVA measured using ETDRS testing. The study endpoint was reached if the study patient experienced vision loss of ≥10 letters (≥2 lines) at any visit or 5-9 letters (1-2 lines) at 2 consecutive visits ≤28 days apart, based on the criteria for initiating anti-VEGF therapy as defined in the DRCR Protocol V study.
Measured: 6 months
Secondary outcomes (5)
Visual Acuity at 6 Month
Visual acuity measured using ETDRS
Measured: 6 months
Low Luminance Visual Acuity at 6 Months
Low Luminance Visual acuity measured with a 2.0-log unit neutral density filter
Measured: 6 months
Contrast Sensitivity at 6 Months
Contrast sensitivity is measured using a single, large letter size (20/60 optotype) with contrast varying across groups of letters. The contrast sensitivity chart (CS) uses letters whose contrast varies from high to low. The scale is 0.0 (minimum) to 2.0 (maximum). A higher score equates to a better outcome. The score is based on the contrast of the last group in which 2 or 3 letters were correctly read. A score of 2.0 indicates normal CS of 100%. Scores < than 2.0 signify poorer CS; scores < than 1.5 is consistent with visual impairment; a score < than 1.0 represents visual disability.
Measured: 6 months
Central Subfield Thickness (CST) at 6 Months
Using Heidelberg Spectralis device to measure central subfield thickness (CST)
Measured: 6 months
Microperimetry Average Threshold at 6 Month
Performed using the Macular Integrity Assessment (MAIA) Instrument
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start20 Apr 2018
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
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.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- IRIDEX Corporation
- Responsible party
- Sponsor
- Investigators
- Glenn Yiu, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519581
- Sponsor's protocol ID
- 1141752
- Acronym
- PULSE
- Status last verified
- Dec 2024
- First submitted
- 26 Apr 2018
- Last updated
- 17 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micropulse for Suppression of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT03519581
- Acronym / sponsor ID
- PULSE / 1141752
- Conditions
- Diabetic Macular Edema
- Keywords
- DME, micropulse laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- IRIDEX Corporation
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Posted 17 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic retinopathy is one of the most common complications of diabetes and diabetic macular edema (DME) is one of the most common causes of vision loss in diabetes.
The purpose of this study is to determine if early intervention with micropulse laser treatment in eyes with good visual acuity (20/32 or better) will improve or stabilize vision loss due to the complications of diabetic macular edema.
Detailed description
This is a randomized, controlled clinical trial comparing subthreshold micropulse laser versus sham laser treatment for eyes with diabetic macular edema with good visual acuity of 20/32 or better.
Subjects will be randomized to receive either subthreshold micropulse laser treatment or no treatment (sham). Randomization will occur as a ratio of 2:1 and will take place during the clinic visit.
Subjects selected for the study will undergo a complete ophthalmic examination, including measurements of best corrected visual acuity, low luminance visual acuity, contrast sensitivity (using ETDRS testing with a masked coordinator), intraocular pressure, slit lamp exam including documentation of lens status, and dilated funduscopic exam with standard dilating agents used at the UC Davis Eye Center. Subjects will then undergo baseline imaging including Spectral Domain Ocular Coherence Tomography (SD-OCT), fundus autofluorescence (FAF) and microperimetry testing. Both the use of OCT, FAF, and microperimetry testing are within the standard of care for the management of DME.
The duration of an individual subject's participation in the study will be two years which will include at least 10 total visits at various time points including on the day of enrollment, followed by 1, 3, 6, 9, and 12, 15, 18, 21, 24 months after the day of enrollment.
The subjects in the treatment arm will be treated on the day of randomization by SML photocoagulation using the Iridex IQ577 laser unit with TxCell scanning laser delivery system.
Subjects in the sham treatment arm will undergo the same set up procedures as those receiving the laser treatment, however, no actual laser treatment will occur.
Subjects will then return to the clinic for repeat ophthalmic exam, OCT imaging, and microperimetry at 1 month, 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month and 24 month time points, which is similar in frequency as standard of care.
Patients in the treatment arm are eligible for repeat SML laser at any subsequent visit if there is any decline in vision (1 or more ETDRS lines) or worsening in edema (>10% increase), at the discretion of the treating physician. If vision declines to 20/40 or worse at any study visit, patients in the treatment arm will undergo repeat treatment with SML laser, while those in the sham arm will undergo repeat sham laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micropulse Laser Treatment | Active comparator | Device: Micropulse Laser TreatmentSubjects assigned to the micropulse laser arm of the trial will undergo the following procedures: 1. Confirmation of the subject's identity and eye to be treated 2. Subject's eye will be dilated 3. Subject will be positioned at the slit lamp for treatment 4. Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea. |
| Sham Treatment | Placebo comparator | Device: Sham TreatmentSubjects assigned to the sham arm of the trial will undergo the following procedures: 1. Confirmation of the subject's identity and eye to be treated 2. Subject's eye will be dilated 3. Subject will be positioned at the slit lamp for treatment 4. No Actual laser treatment will occur |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >=18 years
- Type 1 or type 2 diabetes mellitus
- Clinical evidence of center-involved DME confirmed on OCT, and defined by OCT
- Best corrected visual acuity of 20/32 or better on ETDRS testing
Key exclusion criteria (14 listed)
- Macular edema from causes other than DME
- An ocular condition is present such that in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (i.e/foveal atrophy, pigment abnormalities, dense hard exudates)
- An ocular condition is present other than DME which may contribute to macular edema (i.e/vein occlusion, ERM, uveitis, RP, etc…).
- Cataract that in the opinion of the investigator may alter visual acuity throughout the course of the study
- History of prior laser or other surgical, intravitreal, or peribulbar treatment for DME in the study eye within the prior 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 |
|---|---|---|
| Micropulse Laser TreatmentParticipant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea. | Device | Micropulse Laser Treatment |
| Sham TreatmentParticipant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur. | Device | Sham Treatment |
Primary outcome
Percentage of Subjects With Vision Loss to 20/40 or Worse
Time frame: 6 months
BCVA measured using ETDRS testing. The study endpoint was reached if the study patient experienced vision loss of ≥10 letters (≥2 lines) at any visit or 5-9 letters (1-2 lines) at 2 consecutive visits ≤28 days apart, based on the criteria for initiating anti-VEGF therapy as defined in the DRCR Protocol V study.
5 secondary outcomes
Visual Acuity at 6 Month
Time frame: 6 months
Low Luminance Visual Acuity at 6 Months
Time frame: 6 months
Contrast Sensitivity at 6 Months
Time frame: 6 months
Central Subfield Thickness (CST) at 6 Months
Time frame: 6 months
Microperimetry Average Threshold at 6 Month
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Learn more or sign up for the study here!Link provided by the sponsor.
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
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.
Glenn Yiu, MD, PhD principal investigator
University of California, Davis
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 in people with Diabetic Macular Edema, run by University of California, Davis at 1 site in United States.
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 7 inclusion and 14 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 17 Dec 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2024). 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?
Percentage of Subjects With Vision Loss to 20/40 or Worse (time frame: 6 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 17 Dec 2024.