Micropulse for Suppression of Diabetic Macular Edema

NCT03519581 | Completed Results DMC FDA Device

• 1 other identifier: 1141752
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

DME; micropulse laser

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Vision Loss to 20/40 or Worse

  BCVA measured using ETDRS testing. The study endpoint was reached if the study patient experienced vision loss of ≥10 letters (≥2 lines) at any visit or 5-9 letters (1-2 lines) at 2 consecutive visits ≤28 days apart, based on the criteria for initiating anti-VEGF therapy as defined in the DRCR Protocol V study.

  6 months

Secondary Outcomes (5)

• Visual Acuity at 6 Month

  6 months

• Low Luminance Visual Acuity at 6 Months

  6 months

• Contrast Sensitivity at 6 Months

  6 months

• Central Subfield Thickness (CST) at 6 Months

  6 months

• Microperimetry Average Threshold at 6 Month

  6 months

Study Arms (2)

Micropulse Laser Treatment

ACTIVE COMPARATOR

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

Sham Treatment

PLACEBO COMPARATOR

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

Interventions

Micropulse Laser Treatment DEVICE

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.

Micropulse Laser Treatment

Sham Treatment DEVICE

Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.

Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Heidelberg Spectralis: 290μ in women, and 305μ in men
• Best corrected visual acuity of 20/32 or better on ETDRS testing

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead
• IRIDEX Corporation: collaborator

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Related Links

• Learn more or sign up for the study here!

Results Point of Contact

• Title: Clinical Research Supervisor
• Organization: University of California, Davis Eye Center

dcmacias@ucdavis.edu

916 734-6303

Study Officials

• Glenn Yiu, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 9, 2018
• Study Start: April 20, 2018
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: December 17, 2024
• Results First Posted: December 17, 2024

Record last verified: 2024-12

Locations

US (1)