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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Amplify-RHYTHM for diabetic retinopathy?

Research on subthreshold micropulse diode laser photocoagulation, a similar treatment, shows it can be effective and safe for diabetic macular edema, which is related to diabetic retinopathy. This suggests that treatments like Amplify-RHYTHM might also be beneficial for diabetic retinopathy. ^{1 2 3 4 5}

What is the purpose of this trial?

This study will test the effects of a 6-week comprehensive circadian optimization intervention Amplify-RHYTHM in patients with diabetic retinopathy. The outcomes of interest are objective and subjective sleep parameters, evening salivary cortisol and melatonin levels, and glucose parameters from continuous glucose monitoring

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Subthreshold micropulse diode laser photocoagulation for diabetic macular edema in Japanese patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The National Diabetic Retinopathy Laser Treatment Audit. I. Maculopathy. [2016]

3. Japan pubmed.ncbi.nlm.nih.gov

Comparison of two-year treatment outcomes between subthreshold micropulse (577 nm) laser and aflibercept for diabetic macular edema. [2021]

4. United States 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

PHOTOCOAGULATION VERSUS RANIBIZUMAB FOR PROLIFERATIVE DIABETIC RETINOPATHY: Should Baseline Characteristics Affect Choice of Treatment? [2020]