N/A
Completed N=27
Micropulse for Suppression of Diabetic Macular Edema
Source: ClinicalTrials.gov NCT03519581 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Percentage of Subjects With Vision Loss to 20/40 or Worse — 5; 3 Eyes — p=.76
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Vision Loss to 20/40 or Worse |
5; 3 | .76 |
| SECONDARY Visual Acuity at 6 Month |
79.4; 83.9 | .16 |
| SECONDARY Low Luminance Visual Acuity at 6 Months |
30.7; 40.1 | .12 |
| SECONDARY Contrast Sensitivity at 6 Months |
1.54; 1.61 | .68 |
| SECONDARY Central Subfield Thickness (CST) at 6 Months |
357.8; 356.9 | .96 |
| SECONDARY Microperimetry Average Threshold at 6 Month |
22.5; 24.4 | .50 |
Eligibility 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
- Heidelberg Spectralis: 290μ in women, and 305μ in men
- Best corrected visual acuity of 20/32 or better on ETDRS testing
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03519581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.