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Micropulse for Suppression of Diabetic Macular Edema (PULSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03519581
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
IRIDEX Corporation
Information provided by (Responsible Party):
University of California, Davis

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
Diabetic Macular Edema Device: Micropulse Laser Treatment Device: Sham Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Micropulse Laser Treatment

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.
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:

  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
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Average change in Visual Acuity [ Time Frame: 3 months ]
    Visual acuity measured using ETDRS

  2. Average change in Visual Acuity [ Time Frame: 6 months ]
    Visual acuity measured using ETDRS

  3. Average change in Visual Acuity [ Time Frame: 9 months ]
    Visual acuity measured using ETDRS

  4. Average change in Visual Acuity [ Time Frame: 12 months ]
    Visual acuity measured using ETDRS

  5. Average change in Visual Acuity [ Time Frame: 15 months ]
    Visual acuity measured using ETDRS

  6. Average change in Visual Acuity [ Time Frame: 18 months ]
    Visual acuity measured using ETDRS

  7. Average change in Visual Acuity [ Time Frame: 21 months ]
    Visual acuity measured using ETDRS

  8. Average change in Visual Acuity [ Time Frame: 24 months ]
    Visual acuity measured using ETDRS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >=18 years
  2. Type 1 or type 2 diabetes mellitus
  3. 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:

    1. Zeiss Cirrus: 275μ in women, and 290μ in men
    2. Heidelberg Spectralis: 290μ in women, and 305μ in men
  4. Best corrected visual acuity of 20/32 or better on ETDRS testing

Exclusion Criteria:

  1. Macular edema from causes other than DME
  2. 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)
  3. An ocular condition is present other than DME which may contribute to macular edema (i.e/vein occlusion, ERM, uveitis, RP, etc…).
  4. Cataract that in the opinion of the investigator may alter visual acuity throughout the course of the study
  5. History of prior laser or other surgical, intravitreal, or peribulbar treatment for DME in the study eye within the prior 6 months.
  6. More than 4 prior intraocular injections for treatment of DME at any time
  7. More than 1 prior focal/grid macular photocoagulation session for treatment of DME at any time
  8. History of topical steroid or NSAID treatment within 30 days prior to randomization
  9. History of PRP within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization.
  10. Any history of vitrectomy.
  11. 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
  12. History of YAG capsulotomy performed within 2 months prior to randomization.
  13. Aphakia
  14. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis

Information from the National Library of Medicine

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


Contacts
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Contact: Cynthia Wallace 916 734 6393 clwallace@ucdavis.edu
Contact: Denise Macias, BA 916 734 6303 dcmacias@ucdavis.eud

Locations
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United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Cynthia Wallace    916-734-6393    clwallace@ucdavis.edu   
Contact: Denise Macias, BA    916 734 6303    dcmacias@ucdavis.edu   
Principal Investigator: Glenn Yiu, MD, PhD         
Sponsors and Collaborators
University of California, Davis
IRIDEX Corporation
Investigators
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Principal Investigator: Glenn Yiu, MD, PhD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03519581    
Other Study ID Numbers: 1141752
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, Davis:
DME
micropulse laser
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases