Amplify-RHYTHM for Diabetic Retinopathy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Melatonin, Antipsychotics, Antidepressants, Sedatives

Disqualifiers: Illicit drug use, Stroke, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Amplify-RHYTHM to determine if it can improve sleep and diabetes management for people with diabetic retinopathy—a condition where diabetes affects the eyes. The program includes special light exposure and weekly coaching sessions. It examines changes in sleep patterns, stress hormones, and blood sugar levels with this treatment. Individuals with type 2 diabetes, moderate eye issues from it, a desire for better sleep, and a smartphone may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative methods for enhancing sleep and diabetes management.

Will I have to stop taking my current medications?

The trial requires that you stop using melatonin, antipsychotics, and more than one antidepressant. If you are on one antidepressant, the dose must be stable for 6 weeks before joining the trial.

What prior data suggests that the Amplify-RHYTHM intervention is safe for patients with diabetic retinopathy?

Research shows that treatments focusing on the body's natural clock, known as the circadian rhythm, can help manage diabetic retinopathy without major safety concerns. Although specific safety data for Amplify-RHYTHM from past studies is unavailable, this approach uses non-invasive methods like scheduled light exposure and coaching sessions. These methods are generally safe because they don't involve drugs or surgeries.

The trial is labeled "Not Applicable" for phase, indicating that safety hasn't been fully tested yet. However, similar non-invasive strategies have been well-tolerated in other situations. Therefore, even without direct safety evidence for Amplify-RHYTHM, the nature of the treatment suggests it is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Amplify-RHYTHM is unique because it combines timed light exposure with weekly remote coaching sessions, offering a non-invasive approach to managing diabetic retinopathy. Unlike standard treatments like laser therapy or anti-VEGF injections, which focus on directly addressing the symptoms or causes of retinal damage, Amplify-RHYTHM aims to harness the body's natural circadian rhythms to potentially improve eye health. Researchers are excited about this treatment as it introduces a novel mechanism by leveraging light exposure, which could provide a more holistic and potentially less burdensome option for patients.

What evidence suggests that Amplify-RHYTHM is effective for diabetic retinopathy?

Research has shown that disruptions in the natural sleep-wake cycle, known as circadian rhythms, can worsen diabetic retinopathy, an eye condition affecting people with diabetes. In this trial, participants will receive the Amplify-RHYTHM treatment, which uses scheduled light exposure and remote coaching to stabilize these rhythms. Early results suggest that stabilizing circadian rhythms may improve sleep and blood sugar control, which is crucial for managing diabetic retinopathy. Although direct data on Amplify-RHYTHM is limited, the method is based on strong evidence that better sleep patterns can positively affect diabetes-related eye issues. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with diabetic retinopathy, a condition affecting the eyes due to diabetes. Participants should be interested in trying a new intervention called Amplify-RHYTHM for 6 weeks to potentially improve their sleep and biological rhythms.

Inclusion Criteria

I want to improve my sleep.

I have type 2 diabetes.

I have had moderate diabetic eye disease in the past.

Exclusion Criteria

I need oxygen for my chronic lung condition.

No health insurance coverage

I have severe liver disease, like cirrhosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week comprehensive circadian optimization intervention called Amplify-RHYTHM, which includes timed light exposure and weekly remote coaching sessions.

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on sleep parameters, salivary melatonin and cortisol levels, and glucose monitoring.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amplify-RHYTHM

Trial Overview The study is testing Amplify-RHYTHM, an intervention designed to optimize circadian rhythms over a period of 6 weeks. It aims to assess changes in sleep quality, stress hormones like cortisol and melatonin, as well as blood sugar levels using continuous monitoring.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Amplify-RHYTHM will consist of two main components: 1) timed light exposure, 2) weekly remote coaching session.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

Subthreshold micropulse diode laser photocoagulation effectively reduced central macular thickness (CMT) in patients with diabetic macular edema after 3 months, indicating its efficacy in managing this condition.

The treatment maintained visual acuity in 94.7% of patients over 12 months with minimal retinal damage, as no obvious laser scars were detected, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthreshold micropulse diode laser photocoagulation for diabetic macular edema in Japanese patients. Ohkoshi, K., Yamaguchi, T.[2022]

Ranibizumab was found to be more effective than panretinal photocoagulation (PRP) in improving visual acuity and preventing vision-impairing diabetic macular edema in patients with proliferative diabetic retinopathy over a 2-year period.

No baseline characteristics favored PRP over ranibizumab, suggesting that ranibizumab is a strong alternative treatment option for all patients with proliferative diabetic retinopathy, particularly those with higher mean arterial pressure or more advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PHOTOCOAGULATION VERSUS RANIBIZUMAB FOR PROLIFERATIVE DIABETIC RETINOPATHY: Should Baseline Characteristics Affect Choice of Treatment? Bressler, SB., Beaulieu, WT., Glassman, AR., et al.[2020]

In a study of 130 eyes from 125 patients over 24 months, dexamethasone implants significantly improved vision in both treatment-naive and anti-VEGF refractory eyes with diabetic macular edema, but treatment-naive eyes experienced greater vision gains (+11.3 letters) compared to refractory eyes (+7.3 letters).

Both groups showed a significant reduction in central subfield thickness (CST) after treatment, although CST remained higher in refractory eyes, indicating that while dexamethasone is effective for both groups, treatment-naive eyes respond better.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DEXAMETHASONE IMPLANT FOR DIABETIC MACULAR EDEMA IN NAIVE COMPARED WITH REFRACTORY EYES: The International Retina Group Real-Life 24-Month Multicenter Study. The IRGREL-DEX Study. Iglicki, M., Busch, C., Zur, D., et al.[2020]

In a study of 546 patients undergoing their first laser treatment for diabetic maculopathy, 65.2% of cases were detected through systematic screening, highlighting the importance of regular eye examinations for early detection.

The majority of patients (83.1%) received treatment within 8 weeks of being listed, indicating a relatively efficient treatment process, although 7% experienced longer waiting times of over 12 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The National Diabetic Retinopathy Laser Treatment Audit. I. Maculopathy. Bailey, CC., Sparrow, JM., Grey, RH., et al.[2016]

In a study of 164 diabetic macular edema patients, aflibercept showed faster and greater improvements in both visual acuity and central macular thickness compared to micropulse laser treatment at the 6-month mark.

However, by the 12 and 24-month follow-ups, the long-term efficacy of both treatments was similar, suggesting that starting with micropulse laser and using aflibercept as a rescue option could still lead to effective outcomes without compromising visual improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two-year treatment outcomes between subthreshold micropulse (577 nm) laser and aflibercept for diabetic macular edema. Lai, FHP., Chan, RPS., Lai, ACH., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06183476

Circadian Amplification in Diabetic Retinopathy This study will test the effects of a 6-week comprehensive circadian optimization intervention Amplify-RHYTHM in patients with diabetic retinopathy. The ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11439719/

Association between rest-activity rhythm and diabetic ... The disruption of circadian rhythm has been reported to aggravate the progression of diabetic retinopathy (DR). Rest-activity rhythm (RAR) ...

3. clinconnect.io clinconnect.io/trials/NCT06183476?queryID=99622d13133c646faf2c&apos=165

Circadian Amplification in Diabetic Retinopathy - ClinConnect This study will test the effects of a 6-week comprehensive circadian optimization intervention Amplify-RHYTHM in patients with diabetic retinopathy.

4. withpower.com withpower.com/clinical-trials/for-diabetic-retinopathy

Top Diabetic Retinopathy Clinical Trials | Power This study will test the effects of a 6-week comprehensive circadian optimization intervention Amplify-RHYTHM in patients with diabetic retinopathy. The ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06183476?cond=diabetes

Circadian Amplification in Diabetic Retinopathy A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10730663/

Identification of key genes modules linking diabetic ... We initially identified six key genes associated with circadian rhythm in DR, including COL6A3, IGFBP2, IGHG4, KLHDC7A, RPL26P30, and MYL6P4.

7. eyewiki.org eyewiki.org/Clinical_Trials_in_Medical_Retina

Clinical Trials in Medical Retina Outcome measures were early treatment of diabetic retinopathy visual acuity, retinal thickness, lesion size and safety evaluation. Results. A ...