Micropulse for Suppression of Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

— PULSE  

Official title:

Micropulse for Suppression of Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519581
• Other study ID #: 1141752
• Status: Completed
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: January 31, 2023

Study information

• Verified date: May 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 improve or stabilize vision loss due to the complications of diabetic macular edema.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	IRIDEX Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with vision loss to 20/40 or worse	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.	12 month
Primary	Percentage of subjects with vision loss to 20/40 or worse	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.	24 month
Secondary	Average change in Visual Acuity	Visual acuity measured using ETDRS	3 months
Secondary	Average change in Visual Acuity	Visual acuity measured using ETDRS	6 months
Secondary	Average change in Visual Acuity	Visual acuity measured using ETDRS	9 months
Secondary	Average change in Visual Acuity	Visual acuity measured using ETDRS	12 months
Secondary	Average change in Visual Acuity	Visual acuity measured using ETDRS	15 months
Secondary	Average change in Visual Acuity	Visual acuity measured using ETDRS	18 months
Secondary	Average change in Visual Acuity	Visual acuity measured using ETDRS	21 months
Secondary	Average change in Visual Acuity	Visual acuity measured using ETDRS	24 months

External Links

•   Learn more or sign up for the study here!