PULSE: Micropulse for Suppression of Diabetic Macular Edema
Study Details
Study Description
Brief 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 improve or stabilize vision loss due to the complications of diabetic macular edema.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Micropulse Laser Treatment Subjects assigned to the micropulse laser arm of the trial will undergo the following procedures: Confirmation of the subject's identity and eye to be treated Subject's eye will be dilated Subject will be positioned at the slit lamp for treatment Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea. |
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: Confirmation of the subject's identity and eye to be treated Subject's eye will be dilated Subject will be positioned at the slit lamp for treatment No Actual laser treatment will occur |
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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of subjects with vision loss to 20/40 or worse [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 [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.
Secondary Outcome Measures
- Average change in Visual Acuity [3 months]
Visual acuity measured using ETDRS
- Average change in Visual Acuity [6 months]
Visual acuity measured using ETDRS
- Average change in Visual Acuity [9 months]
Visual acuity measured using ETDRS
- Average change in Visual Acuity [12 months]
Visual acuity measured using ETDRS
- Average change in Visual Acuity [15 months]
Visual acuity measured using ETDRS
- Average change in Visual Acuity [18 months]
Visual acuity measured using ETDRS
- Average change in Visual Acuity [21 months]
Visual acuity measured using ETDRS
- Average change in Visual Acuity [24 months]
Visual acuity measured using ETDRS
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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Heidelberg Spectralis: 290μ in women, and 305μ in men
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Best corrected visual acuity of 20/32 or better on ETDRS testing
Exclusion Criteria:
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Macular edema from causes other than DME
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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)
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An ocular condition is present other than DME which may contribute to macular edema (i.e/vein occlusion, ERM, uveitis, RP, etc…).
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Cataract that in the opinion of the investigator may alter visual acuity throughout the course of the study
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History of prior laser or other surgical, intravitreal, or peribulbar treatment for DME in the study eye within the prior 6 months.
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More than 4 prior intraocular injections for treatment of DME at any time
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More than 1 prior focal/grid macular photocoagulation session for treatment of DME at any time
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History of topical steroid or NSAID treatment within 30 days prior to randomization
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History of PRP within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization.
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Any history of vitrectomy.
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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
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History of YAG capsulotomy performed within 2 months prior to randomization.
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Aphakia
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Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, Davis | Sacramento | California | United States | 95817 |
Sponsors and Collaborators
- University of California, Davis
- IRIDEX Corporation
Investigators
- Principal Investigator: Glenn Yiu, MD, PhD, University of California, Davis
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1141752