An observational study in Diabetic Retinopathy, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 21 Years to 98 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by University of Alabama at Birmingham · Observational
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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 40th largest by planned enrollment of the 70 observational ones that give a count, is one of 11 that started in 2018, is one of 70 observational ones, reaches primary completion later than 15 of the 54 other live ones, and was the 137th registered.
778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.
Browse Diabetic Retinopathy studies →36 of the 267 studies in Diabetic Retinopathy with a site in United States are open now. Recruiting first, the newest first:
University of Wisconsin, Madison · Sites in United States
Ages 22+
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Israel and 1 more country
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Australia and 1 more country
Ages 18+
Digital Diagnostics, Inc. · Sites in United States
Ages 22+ · Healthy volunteers
BioAge Labs, Inc. · Sites in United States
Ages 18–75
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
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: 21 Years to 98 Years · all sexes · healthy volunteers too.
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267 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 37 · Phase 2 64 · Phase 3 35 · Phase 4 20
First in 1992; this study’s year is marked. 11 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 104 is below the median of 172 across 263 observational studies indexed under Diabetic Retinopathy.
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.
This tab as a report to print or save as PDF → With an account.
114 of 267 have an industry lead sponsor. The 10 most frequent:
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
University of Alabama at Birmingham has 7 studies 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 |
Add all 19 to your calendar (.ics) → With an account.
Among the 267 studies in Diabetic Retinopathy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Results from large clinical trials demonstrate a strong association between lipid abnormalities and progression of the most common microvascular complication, diabetic retinopathy (DR). We found that activation of a master regulator of cholesterol metabolism, the nuclear hormone receptors liver X receptors (LXRα/LXRβ), prevents DR in rodent models. In this application, we seek to understand the mechanisms responsible for the beneficial effects of LXR agonists on retina and on bone marrow (BM) to preserve the function of reparative cells while reducing inflammatory cell.
Diabetic retinopathy (DR) is a disabling microvascular complication. Despite recent advances using pharmacotherapy, a cure for DR has yet to be realized. Thus, a conceptual and technical breakthrough to identify novel targets, and a strategy to cure this complication is paramount. We believe that the recent clinical evidence from large clinical trials demonstrating a strong association between lipid abnormalities and DR progression and the discovery that activation of the nuclear hormone receptors liver X receptors (LXRα/LXRβ) prevents DR in rodent models offers such a breakthrough. The detrimental effect of dyslipidemia is not limited to the vasculature but also leads to dysfunction of circulating angiogenic cells (CAC) and of macrophages. The endogenous ligands for LXRs are oxidative metabolites of cholesterol that serve as intracellular cholesterol "sensors". LXR agonists operate, in part, by transcriptional upregulation of genes involved in promoting cholesterol efflux and inhibition of cholesterol uptake; and by inhibiting inflammation. Our published studies and new preliminary data show that pharmacological LXR activation prevents DR development in both T1D and T2D rodent models. In this application, we seek to understand the mechanisms involved in this beneficial effect. We put forth the hypothesis that LXR activation will restore cholesterol homeostasis in the diabetic retina and correct diabetes-induced bone marrow dysfunction to sustain CAC levels and function and to reduce of myeloid cell production.
Patients who have retinal abnormalities other than diabetic retinopathy will be excluded. Patients who have systemic conditions that influence hematopoietic stem cell function such as cardiovascular disease, malignant disease, diabetes, hematologic disorder, or estimated glomerular filtration rate less than 60 mL/min or who have undergone treatment with erythropoietin will be excluded. We will record all medications including antihypertensive drug treatment, treatment with statins, Angiotensin-Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB) or other pharmacological agents that may influence CD34+ cell function. Baseline characteristics will be recorded, including age, lipid parameters, body mass index (BMI), blood pressure, smoking history, antioxidant intake and use of nutritional supplements.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Any man or woman between the ages of 21- 98 years of age will be eligible to participate. To participate in the study as a study subject we will require that the subject must carry the diagnosis of healthy control.
Biological: blood draw
Patients with diabetes but with no evidence of diabetic retinopathy
Biological: blood draw
Diabetics with mild non proliferative diabetic retinopathy (NPDR).
Biological: blood draw
Diabetics with moderate NPDR
Biological: blood draw
Diabetic with severe NPDR.
Biological: blood draw
Diabetics with proliferative diabetic retinopathy (PDR)
Biological: blood draw
Blood sample will be obtained and CD34+ cells will be isolated for functional testing.
Assessing CD34+ cells function
We are isolating CD34+ cells from peripheral blood and then examining the cell membrane characteristics of CD34+ cells and their in vitro function.
Time frame: from blood draw to 48 hours
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2018 (actual). Primary completion is estimated for Dec 2026, 107 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 107 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.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of Alabama at Birmingham →