New nose spray could help diabetic eye disease when shots fail
NCT ID NCT06881888
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new nose spray version of the drug octreotide for people with diabetic macular edema, a condition that causes vision loss from fluid buildup in the eye. The trial will include 60 adults whose eye swelling has not improved with standard treatments. Researchers will measure changes in retinal thickness and vision over time to see if the spray is safe and effective.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- 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 to 90 years
- 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.
Inclusion Criteria: 1. Age range 18-90 2. Clinical diagnosis of diabetic retinopathy with diabetic macular edema (defined as CST greater than 250 and presence of microglia/macrophages on OCT) with a visual acuity between 20/32 and 20/200. 3. Written informed consent is provided. 4. Males and females 5. Routine laboratory study results with bilirubin, aspartate aminotransferase and/or alanine aminotransferase, and creatinine within normal limits. Exclusion Criteria: 1. History of difficult to control diabetes or hypertension 2. Eyes receiving laser photocoagulation in the last 6 months or intravitreous treatment for diabetic macular edema in the past 3 months. 3. Eye having undergone YAG capsulotomy in the last 3 months. 4. Having other ocular surgeries in the last 6 months (examples include but not limited to cataract surgery, scleral buckle, trabeculectomies, etc.). 5. All women of childbearing potential must have a negative urine pregnancy test at the Screening Visit and throughout the study. Sexually active women participating in the study must use a medically acceptable form of contraception. 6. Chronic infectious disease (e.g. HIV, HCV) 7. Positive urine β-hCG test day of visit or a serum beta-HCG test within 48 hours prior to the administration of intranasal octreotide. 8. Other ocular diseases or fundus diseases 9. Patients with a history of intolerance or hypersensitivity to octreotide or use of octreotide in the preceding 2 months. 10. Currently taking an anti-inflammatory medication (e.g. anti-inflammatory agents, glucocorticoids or other immune modulating medications); 11. Use of cyclooxygenase-2 (COX-2) inhibitors for \< 6 months prior to study entry or dose changes after study entry. Limited as-needed use is permitted prior to study entry but not during the study. 12. Use of statins that cross the blood brain barrier such as atorvastatin will not be permitted during the study as they have been shown to reduce levels of pro-inflammatory cytokines. 13. Any degree of hepatic or renal insufficiency that in the Investigator's judgement would pose a safety risk for treatment with octreotide. 14. Patients who based on history or mental status examination have a significant risk of committing suicide, or who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others. 15. Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial. 16. Patients with a current known infection or who are acutely ill. 17. Patients with an autoimmune disease (i.e., Lupus, Rheumatoid Arthritis). 18. Patients with thyroid disorders unless euthyroid at screening. 19. Patients with cancer not in remission. 20. Inability to tolerate or intranasal administration of investigated drug and experiences severe irritation or sneezing. 21. Inability to attend scheduled study visits, plans for family relocation during the study, or any other criteria that the investigator may determine to be associated with inability to complete the study. 22. Limited mental capacity rendering the subject unable to provide written informed consent or comply with evaluation procedures. 23. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols. 24. Use of any investigational drug within 30 days prior to the baseline visit.
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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
1 site. 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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The University of Alabama at Birmingham
Birmingham, Alabama, 35243, United States
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Other studies related to the condition(s) this trial covers.
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- Could a biosimilar eye injection offer a new way to treat diabetic macular edema?