NCT07270133 Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes
| NCT ID | NCT07270133 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jaeb Center for Health Research |
| Condition | Diabetic Retinal Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2026-06-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07270133 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Retinal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07270133 currently recruiting?
Yes, NCT07270133 is actively recruiting participants. Visit ClinicalTrials.gov or contact Jaeb Center for Health Research to inquire about joining.
Where is the NCT07270133 trial being conducted?
This trial is being conducted at Augusta, United States, Boston, United States, Detroit, United States, Monroeville, United States.
Who is sponsoring the NCT07270133 clinical trial?
NCT07270133 is sponsored by Jaeb Center for Health Research. The trial plans to enroll 450 participants.