An observational study in Diabetic Retinopathy and Diabetic Macular Edema, sponsored by Charles Drew University of Medicine and Science. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Charles Drew University of Medicine and Science · Observational
Among 267 studies in Diabetic Retinopathy with a site in United States — 36 open to participants now, 56 under way, 6 of them phase 3. Diabetic Retinopathy · United States.
Among the 267 studies in Diabetic Retinopathy with a site in United States, this one is the 24th largest by enrollment of the 70 observational ones, is one of 11 that started in 2018, is one of 70 observational ones, reaches primary completion later than 25 of the 54 other live ones, and was the 144th registered.
778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.
This study's enrollment of 300 is above the median of 172 across 263 observational studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →36 of the 267 studies in Diabetic Retinopathy with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 92 Diabetic Retinopathy studies recruiting now, 60 (65%) set no upper age limit and 10 (11%) stop at 75 or younger; 8 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →267 studies; the count open now beside each. This study's row is marked.
First in 1992; this study’s year is marked. 11 started in 2018.
Median enrollment 72 across the 196 interventional studies, 161 across the 70 observational. Of the 186 that completed or were terminated, 66 (35%) have results posted.
114 of 267 have an industry lead sponsor. The 10 most frequent:
Charles Drew University of Medicine and Science is the lead sponsor of 43 studies on the registry; 1 is open to participants now.
Charles Drew University of Medicine and Science has 1 study filed under Diabetic Retinopathy — fewer than ten, so there is no comparison to draw.
19 of the studies in Diabetic Retinopathy with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07235085Phase 3Ocular Therapeutix, Inc.A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy | 2027-03 |
| NCT06191094University of Colorado, DenverPre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy | 2026-12 |
| NCT04008121MediBeaconFeasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium | 2026-12 |
| NCT07891910Retina Consultants of DelmarvaIopidine to Decrease Intraocular Pressure Rise After Injections | 2026-12-01 |
| NCT05463289Johns Hopkins UniversityACCESS 2: AI for pediatriC diabetiC Eye examS Study 2 | 2026-12-30 |
Among the 267 studies in Diabetic Retinopathy with a site in United States, from their registry updates:
The objective of this study is to compare the results of a deep learning approach to diabetic retinopathy assessment with results from (1) an in-person examination with an ophthalmologist, and (2) the assessments of optometrists involved in a teleretinal screening program.
This study represents the third aim of a grant with five aims. The study will compare and evaluate the predictive accuracy of: (a) machine learning models developed to grade diabetic retinopathy and assess the presence or absence of diabetic macular edema and (b) the assessments of optometrist readers, both from digital retinal images, against standard of care dilated retinal examinations by board-certified ophthalmologists and/or retinal-specialty fellows for 300 diabetic patients utilizing a Los Angeles County reading center.
For the study, the investigators will recruit 300-500 eligible diabetic patients for in-person eye examinations performed by board certified ophthalmologists and/or retinal-specialty fellows at Los Angeles County reading centers. The study will take place over the course of two visits: a teleretinal screening and an in-person eye examination.
The in-person dilated eye examinations that the study participants will participate in and be compensated for follow the usual standard of care that patients receive in a setting that does not utilize teleretinal screening. Yearly dilated eye examinations are standard of care for all persons with diabetes.
The study population comprises patients with Type I or Type II diabetes who are normally seen at LACDHS clinics and usually screened for diabetic retinopathy via teleretinal screening.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The 300-500 patients to be enrolled for the study are diabetic patients normally seen by the Los Angeles County Department of Health Services (LACDHS) Teleretinal Diabetic Retinopathy Screening Program and Reading Center. In addition to receiving their recommended LACDHS annual teleretinal screening, for the study, participants will receive an additional in-person eye examination.
Other: In-Person Eye Examination
Dilated in-person eye examination by a board-certified ophthalmologist or retinal fellow.
Proportion of patients accurately diagnosed with retinopathy
Proportion of patients accurately diagnosed with retinopathy using machine learning versus proportion accurately diagnosed by teleretinal screening optometrists with in-person eye examinations by ophthalmologists used as a gold standard.
Time frame: 11/2022
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2018 (actual). Primary completion is estimated for May 2027, 103 months after the start.
Of 73 non-industry observational studies under Diabetic Retinopathy, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14. This study's planned 103 months is above that.
Counting every sponsor, half of 90 studies reached it within 28 months; a quarter within 13 and three quarters within 61.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion May 2025 → May 2027 and completion Jul 2025 → Jul 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Charles Drew University of Medicine and Science