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Experimental group for Diabetic Retinopathy

N/A
Waitlist Available
Research Sponsored by Bristlecone Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or Female (age 18-80)
Previously diagnosed with MetS and/or T2DM as measured by possessing at least 2 of the following physiological measures: type II diabetes, BMI >30, HgA1c > 5.7, waist/height ratio >.6, fasting glucose > 125
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights

Study Summary

The study will explore the impact of photobiomodulation (PBM), pulsating at frequencies of red (660nm) and near-infrared (810nm)(NIR), concurrent with a ketogenic dietary protocol (serum ketones @ .5 - 2.0 mmol/L) to mediate vascular features of diabetic retinopathy (DR), diabetic macular edema (DME), age-related macular degeneration (AMD), mid-peripheral drusens, visual acuity and retinal disorders. Red and near-infrared light via light-emitting diode (LED) treatment promotes retinal healing and improves visual acuity by augmenting cellular energy metabolism, enhancing mitochondrial function, increasing cytochrome C oxidase activity, stimulating antioxidant protective pathways and promoting cell survival. LED therapy directly benefits neurons in the retina, the lateral geniculate nucleus and the visual cortex; likewise, a ketogenic dietary protocol shows metabolic and neuro-modulatory benefits within the CNS, most notably as treatment for refractory epilepsy. Photobiomodulation has been approved as a non-significant risk (NSR) modality for the treatment of eye disorders.

Eligible Conditions
  • Diabetic Retinopathy
  • Age-Related Macular Degeneration
  • Mid-Peripheral Drusen Formation
  • Diabetic Macular Edema

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diabetic Macular Edema (DME) pathology
Diabetic Retinopathy
Dry Age-related Macular Degeneration (AMD) pathology
+1 more
Secondary outcome measures
Fasting Glucose
Fasting Insulin
HOMA-IR
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental groupExperimental Treatment2 Interventions
Subjects in the experimental group will receive clinically prescribed meal plans designed to facilitate prolonged benign dietary ketosis (BDK) purposed at glucose regulation, improved insulin sensitivity and restored metabolic flexibility. Photobiomodulation therapy, via Joovv red light/infrared LED device, will be administered three times per week, 20 minutes per session.
Group II: Control groupActive Control1 Intervention
Subjects in the control group will follow current dietary protocol (Standard American Diet- SAD). Photobiomodulation therapy,via Joovv red light/infrared LED device, will be administered three times per week, 20 minutes per session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Photobiomodulation
2016
Completed Phase 3
~590
Ketogenic diet
2020
N/A
~680

Find a Location

Who is running the clinical trial?

University of MinnesotaOTHER
1,367 Previous Clinical Trials
1,587,489 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
34 Patients Enrolled for Diabetic Retinopathy
Bristlecone Health, Inc.Lead Sponsor
1 Previous Clinical Trials
98 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Mar 2025