Not Yet RecruitingPhase 2

Effect of PAE Hydrogel Loaded With tRF-ASO-Exo on Patients With Diabetic Ocular Surface Diseases

30 participantsStarted 2026-02-15

Plain-language summary

The purpose of this study is to determine whether poly（β-amino ester）(PAE)hydrogel loaded with tRNA-derived fragments-antisense oligonucleotides-exosomes(tRF-ASO-Exo) could alleviate symptoms in patients with diabetic ocular surface diseases(DOSD).

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Any past or current malignancy in or around the eye.
. Dry eye traced to scarring (radiation, alkali burn, Stevens-Johnson, cicatricial pemphigoid) or goblet-cell loss (vitamin-A deficiency).
. Active ocular allergy now or expected during the study.
. Ocular or systemic infection at screening/baseline-fever, herpetic keratitis, or on antibiotics.
. Prior immunodeficiency, HIV, hep B/C, active hep A, organ or bone-marrow transplant.
. Any serious chronic illness the PI thinks could mess with endpoints-severe heart/lung disease, uncontrolled hypertension or diabetes.
. Blood donation or major blood loss within 8 weeks of screening.
. Active ocular rosacea, periorbital acne, or pterygium.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

corneal and conjunctival nerve density

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Corneal sensitivity

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

conjunctival goblet cell density

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Changes in Ocular Surface Staining

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

conjunctival vessel density and number of branches

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Changes in Ocular Surface Disease Index (OSDI) Score

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Trial details

NCT IDNCT07382453

SponsorAffiliated Hospital of Nantong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-30

Contact for this trial

Min Ji

0513(81160554) amyji1234@hotmail.com

View on ClinicalTrials.gov More Diabetic Keratopathy trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Any past or current malignancy in or around the eye.
. Dry eye traced to scarring (radiation, alkali burn, Stevens-Johnson, cicatricial pemphigoid) or goblet-cell loss (vitamin-A deficiency).
. Active ocular allergy now or expected during the study.
. Ocular or systemic infection at screening/baseline-fever, herpetic keratitis, or on antibiotics.
. Prior immunodeficiency, HIV, hep B/C, active hep A, organ or bone-marrow transplant.
. Any serious chronic illness the PI thinks could mess with endpoints-severe heart/lung disease, uncontrolled hypertension or diabetes.
. Blood donation or major blood loss within 8 weeks of screening.
. Active ocular rosacea, periorbital acne, or pterygium.

What they're measuring

corneal and conjunctival nerve density

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Corneal sensitivity

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

conjunctival goblet cell density

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Changes in Ocular Surface Staining

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

conjunctival vessel density and number of branches

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Changes in Ocular Surface Disease Index (OSDI) Score

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks