Intranasal Octreotide for Diabetic Macular Edema

This study is testing a nasal spray called Octreotide for people with diabetic macular edema (DME), a swelling in the eye caused by diabetes. Current treatments don't work for everyone, so researchers are looking for new options. You might be able to join if you are 18-90 years old and have DME with specific vision and eye scan findings. Participants will use either the Octreotide nasal spray or a placebo (an inactive spray) three times a day in one nostril. The study will measure changes in your vision and the swelling in your eye after about one month to see if Octreotide is effective. The current status of this study is unclear, and it plans to enroll 60 people.

Study design
This is an interventional study planning to enroll 60 participants. Participants will be randomly assigned to receive either Octreotide nasal spray or a placebo nasal spray.
What's involved
Participants will administer a nasal spray in one nostril three times a day. Measurements of macular central subfield thickness, best corrected visual acuity, and microglia on the retinal surface will be taken up to one month.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for measurements up to one month after starting treatment.

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NCT06881888

Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

Not Yet Recruiting
PHASE1Ages 18–90InterventionalTreatment
University of Alabama at Birmingham
~60 participants
Updated 2025-10-03 on ClinicalTrials.gov
What's tested:Octreotide (drug)Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in macular central subfield thickness
Measured over Up to one month.
+6 more outcomes measured
Diabetic Macular Edema
1 sites across 1 states
Alabama1
  • Maria Grant, MD, FARVO · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

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  • Change in macular central subfield thicknessUp to one month.

    Participants will have an optical coherence tomography at each visit that will measure macular central subfield thickness. Measuring the change at their baseline appointment and each additional study visit.

  • Change in best corrected visual acuityUp to one month.

    Each participant will have best corrected visual acuity measured by Early Treatment of Diabetic Retinopathy study (ETDRS) chart. Enter the full scale.

  • Change in microglia on retinal surfaceUp to one month

    Each participant will have an optical coherence tomography angiography scan measuring the quantity of microglia on the retinal surface.

  • Changes in retinal peripheral capillary free zoneup to one month

    Each participant will have optical coherence tomography angiography and measure differences in retinal peripheral capillary free zone.

  • Changes in retinal foveal avascular zoneup to one month

    Each participant will have optical coherence tomography angiography and measure differences in retinal foveal avascular zone.

  • Changes in retinal capillary densityup to one month

    Each participant will have optical coherence tomography angiography and measure differences in retinal capillary density.

  • Changes in retinal non-perfusion zonesup to one month

    Each participant will have optical coherence tomography angiography and measure differences in retinal non-perfusion zones.