Micropulse for Suppression of Diabetic Macular Edema (PULSE)
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|ClinicalTrials.gov Identifier: NCT03519581|
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 19, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Device: Micropulse Laser Treatment Device: Sham Treatment||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Subjects will be masked to their treatment assignment. The research coordinator that performs the measurement of best corrected visual acuity will be masked to the treatment assignment. The reading center analyst responsible for reviewing and analyzing OCT and microperimetry reports will be masked to treatment assignment.|
|Official Title:||Micropulse for Suppression of Diabetic Macular Edema|
|Actual Study Start Date :||April 20, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Active Comparator: Micropulse Laser Treatment
Subjects assigned to the micropulse laser arm of the trial will undergo the following procedures:
Device: Micropulse Laser Treatment
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.
Placebo Comparator: Sham Treatment
Subjects assigned to the sham arm of the trial will undergo the following procedures:
Device: Sham Treatment
Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
- Percentage of subjects with vision loss to 20/40 or worse [ Time Frame: 12 month ]Visual acuity (VA) measured using ETDRS testing. If visual acuity is 20/40 or worse, subject will be asked to return for retesting within 28 days to confirm findings.
- Percentage of subjects with vision loss to 20/40 or worse [ Time Frame: 24 month ]Visual acuity (VA) measured using ETDRS testing. If visual acuity is 20/40 or worse, subject will be asked to return for retesting within 28 days to confirm findings.
- Average change in Visual Acuity [ Time Frame: 3 months ]Visual acuity measured using ETDRS
- Average change in Visual Acuity [ Time Frame: 6 months ]Visual acuity measured using ETDRS
- Average change in Visual Acuity [ Time Frame: 9 months ]Visual acuity measured using ETDRS
- Average change in Visual Acuity [ Time Frame: 12 months ]Visual acuity measured using ETDRS
- Average change in Visual Acuity [ Time Frame: 15 months ]Visual acuity measured using ETDRS
- Average change in Visual Acuity [ Time Frame: 18 months ]Visual acuity measured using ETDRS
- Average change in Visual Acuity [ Time Frame: 21 months ]Visual acuity measured using ETDRS
- Average change in Visual Acuity [ Time Frame: 24 months ]Visual acuity measured using ETDRS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519581
|Contact: Cynthia Wallace||916 734 firstname.lastname@example.org|
|Contact: Denise Macias, BA||916 734 email@example.com|
|United States, California|
|University of California, Davis||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Cynthia Wallace 916-734-6393 firstname.lastname@example.org|
|Contact: Denise Macias, BA 916 734 6303 email@example.com|
|Principal Investigator: Glenn Yiu, MD, PhD|
|Principal Investigator:||Glenn Yiu, MD, PhD||University of California, Davis|