Longitudinal look at retinal function in people with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This long-term, observational study tracks retinal function and structure in adults with diabetes or non-diabetic controls to understand how diabetic retinal disease progresses. Participants undergo a battery of tests, including visual acuity, reading speed, visual field, contrast sensitivity, electroretinography, and pupillography in both light- and dark-adapted states. The goal is to identify meaningful changes that could serve as primary or surrogate endpoints in future trials. The study is sponsored by Jaeb Center for Health Research with NEI collaboration and involves multiple ophthalmology centers across the U.S. Participation requires meeting specific inclusion criteria and not having certain recent ocular procedures or treatments.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Age ≥ 18 years
* Diagnosed with Type 1 or Type 2 diabetes or non-diabetic control patients
* Best corrected visual acuity 20/32 or better (Snellen) (≥74 ETDRS letters)
* Meets criteria for one of the defined observational groups below
* Able and willing to provide informed consent

Key Exclusion Criteria:

* Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina
* Previous treatment of any kind for diabetic retinopathy or DME
* Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)
* History of rhegmatogenous retinal detachment or macular hole
* History of vitrectomy
* Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months
* Requiring treatment for DR/DME in the next 6 months

Where it's running

• Retina Associates of Southern California
  Huntington Beach, California, United States Recruiting
• Southeast Retina Center, P.C.
  Augusta, Georgia, United States Recruiting
• Boston Medical Center Corporation
  Boston, Massachusetts, United States Recruiting
• Henry Ford Health System
  Detroit, Michigan, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Retina-Vitreous Consultants, Inc.
  Monroeville, Pennsylvania, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Diabetes Complications in People with Cystic Fibrosis-Related Diabetes (SPeCTRuM)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.