New study aims to sharpen eye tests for diabetes patients
NCT ID NCT07567833
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This study follows 100 adults with diabetic eye disease who are already receiving standard anti-VEGF injections for swelling in the center of the retina. Researchers will use advanced vision tests and imaging to track changes over time. The goal is not to test a new drug, but to find better ways to measure treatment success in future clinical trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key inclusion criteria: * Age ≥18 years * Diagnosed with Type 1 or Type 2 diabetes * Best corrected visual acuity 20/320 or better (Snellen) (≥24 ETDRS letters) * At least 1 eye with CI-DME requiring treatment * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Boston Medical Center Corporation
RECRUITINGBoston, Massachusetts, 02118, United States
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Henry Ford Health System
RECRUITINGDetroit, Michigan, 48202, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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Pittsburgh Clinical Trial Consortium
RECRUITINGSewickley, Pennsylvania, 15143, United States
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Retina-Vitreous Consultants, Inc.
RECRUITINGMonroeville, Pennsylvania, 15146, United States
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Southeast Retina Center, P.C.
RECRUITINGAugusta, Georgia, 30909, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The 20-Minute squeeze: how eye injections push pressure up
- Could years of eye injections weigh down the upper eyelid?
- Eye implant takes aim at diabetic macular edema
- Can a single gene therapy injection ease diabetic macular edema?
- Can a new eye injection preserve vision in south asians with diabetes?
- Could a biosimilar eye injection offer a new way to treat diabetic macular edema?