A Study of Experimental Treatment With Micropulse for Diabetic Macular Edema (build-up of fluid in the eye)

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"This study will test the effect of using the subthreshold micropulse diode laser (SML)."
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: diabetic macular edema
Type: Device study
Target:
30 Participants
Investigator:
Description
Diabetic macular edema (DME) is the term used for swelling in the central part of the retina. The retina is the light-sensitive tissue lining the back of the eye and is responsible for sharp, straight-ahead vision. The retina is nourished by blood vessels. These blood vessels can become weakened by diabetes. This causes the retina to become thickened or swollen. Swelling of the central part of the retina can cause vision loss.

Some common treatment strategies for vision loss due to diabetic macular edema are:
- laser treatment
- intra-ocular injections with medications such as corticosteroids
- anti-vascular endothelial growth factor (anti-VEGF)

The purpose of this study is to test the effect of early treatment using the subthreshold micropulse diode laser (SML). This is a laser treatment that delivers laser energy in a “chopped” fashion allowing the tissue being treated to cool between pulses. Previous studies have shown that early intervention with SML may significantly improve or stabilize vision loss.
This study requires

If you choose to participate, and meet the study eligibility criteria, you will be asked to sign a consent form.

On the day you sign the consent (baseline visit), you will be randomly assigned to receive either subthreshold micropulse laser treatment or a sham treatment. A sham treatment is designed to resemble a real laser treatment. The sham procedure is used so that you will not be able to tell if you are receiving the laser treatment or control/observational treatment. The treatment you get will be chosen by chance, like flipping a coin. You will have a higher chance of being assigned to the laser treatment group than the sham treatment group (2:1 ratio). If both eyes meet the inclusion criteria, one eye (worse eye) will be assigned to the treatment group and the fellow eye to the sham treatment group.

 Treatment Group: Subthreshold Micropulse Laser (SML) If you are randomized into the treatment group, you will undergo the laser procedure in the outpatient clinic. This procedure will involve sitting in front of a slit lamp and looking into a light. A numbing gel will be placed in your eye before the laser procedure. Your eye will be held open using a macula lense. This procedure will take approximately 15 minutes to complete. You should not feel any pain, but may experience some blurry vision for several hours after the procedure.

 Sham Treatment Group: Those in the sham treatment arm will not undergo any laser treatment. You will be asked to sit in front of a slit lamp and look into a light. A numbing gel will be placed in your eye. Your eye will be held open using a macula lense. This procedure will take approximately 15 minutes to complete. You should not feel any pain, but may experience some blurry vision for several hours after the procedure.

Study Procedures The study involves 10 scheduled study visits; baseline (day of enrollment), followed by 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after the day of enrollment.

Each study visits will include the following procedures:  Measurement of your best-corrected visual acuity(the ability to read letters on the vision chart); low luminance visual acuity (the ability to read letters on the vision chart using a dark filter to reduce the lighting); and contrast sensitivity (the ability to read letters on the vision chart in shades of grey).  Intraocular pressure measurement: This is a test to measure the pressure inside your eye and is routinely done as part of most eye exams. Eye drops to numb your eyes will be placed in your eyes. The study doctor or staff will touch an instrument to your eyes to measure the pressure inside your eyes.  Complete eye examination: The structures inside the eye will be examined through a special microscope (slit lamp). The back of the eye will also be examined with an ophthalmoscope (an instrument with a strong light and magnifying lens). Your study doctor may use dilating drops in your eyes to widen your pupils.  SD-OCT (Spectral Domain- Optical Coherence Tomography): A measurement of the thickness of your retina. This is a non-contact, non-invasive imaging technique that uses light to view the retina (back of the eye).  Fundus Autofluorescence (FAF): A non-invasive procedure which uses the fluorescent properties of pigments in the retina to create a black and white image.  Microperimetry: A procedure similar to visual fields (you press a trigger each time you perceive a light stimulus) this examination measures your visual perimetry field with an added camera feature to track eye movement and ensure fixation stability. As you perceive the light stimulus, you will press a trigger which is then recorded similar to other widely used perimetry tests (Humphrey visual field test). Testing will take approximately 3-4 minutes per eye. For OCT and FAF, a lubricating artificial tear drop may be used on subjects with dry eyes to enhance image quality as is routinely done. If vision declines to 20/40 or worse at any study visit, patients in the treatment arm will undergo repeat SML laser while those in the sham arm will undergo repeat sham laser.

For all study patients - If at any point your vision becomes 20/40 or worse, you will be asked to return to the clinic within 28 days in order to confirm your 20/40 vision. If you are still 20/40 or worse after this repeat visit, you will have reached the study endpoint. After the study endpoint is reached, you will continue your follow up with your doctor as needed. You may be treated on a monthly, as needed, or "treat-and-extend" basis based on the individual investigator's preference. You will then be given any combination of intravitreal anti-VEGF injection, laser, or steroid injection, based on the discretion of the study doctor. All information from these visits will be documented for the study until the end of your 24 month enrollment.

Who can participate

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:
  4. Zeiss Cirrus: 275μ in women, and 290μ in men
  5. Heidelberg Spectralis: 290μ in women, and 305μ in men
  6. 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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for two years.
Recruitment period
From March 7, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Macias, Denise
Research Topic
Conditions:
  • Diabetic Macular Edema

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