CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 135 enrolled
Drug / intervention
Retilux +1 moredevice
Likely dose
Retilux 670nm wavelength light device (specific dose/treatment parameters not specified)AI-extracted
Key inclusion· 5
  • ✓Age ≥18 years
  • ✓Diagnosis of diabetes mellitus (type 1 or 2)
  • ✓Best corrected visual acuity ≥20/25 (≥79 E-ETDRS letters)
  • ✓Central-involved diabetic macular edema confirmed by OCT: CST ≥290µm (women) or ≥305µm (men) on Zeiss Cirrus, or ≥305µm (women) or ≥320µm (men) on Heidelberg Spectralis
Key exclusion· 12
  • ✕History of chronic renal failure requiring dialysis or kidney transplant
  • ✕Systolic BP >180 or diastolic BP >110 mmHg (unless controlled by antihypertensive therapy)
  • ✕Initiation of intensive insulin therapy (pump or multiple daily injections) within 4 months prior to or planned within 4 months after randomization
  • ✕Anti-VEGF or pro-VEGF treatment within 4 months prior to randomization; these agents prohibited during study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03866473
NCT03866473N/ACompleted
CompareCT.gov

A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema

Jaeb Center for Health Research·interventional·Posted Mar 7, 2019·Updated Sep 19, 2022

In Brief

A clinical study evaluating Retilux and Sham Light Device for Diabetic Macular Edema. Completed, enrolled 135 participants across 20 sites.

Detailed Summary

Randomized clinical trial evaluating the effect of photobiomodulation compared with sham on central subfield thickness (CST) in eyes with central-involved DME and good vision.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Eye Institute (NEI), Juvenile Diabetes Research Foundation, PhotoOptx LLC

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 7, 2019
Enrollment StartApr 10, 2019
Primary CompletionSep 4, 2020
Study CompletionNov 13, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.3 years ago

Interventions

Retiluxdevice

670nm wavelength light

Sham Light Devicedevice

Broad spectrum light device