NCT06881888

Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

Not yet recruiting Phase 1 Last updated 29 September 2025

What this trial tests

Phase 1 trial testing Octreotide (drug) in Diabetic Macular Edema in 60 participants. Not yet recruiting.

Timeline

31 August 2026

Primary endpoint
1 December 2027

1 December 2027

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	31 August 2026
Primary completion	1 December 2027
Estimated completion	1 December 2027
Sites	1 location across United States

Drugs / interventions tested

• Octreotide (drug) — full drug profile →
• Placebo

Conditions studied

• Diabetic Macular Edema — all drugs for Diabetic Macular Edema →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 18 to 90, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in macular central subfield thickness
  Time frame: Up 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 acuity
  Time frame: Up 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 surface
  Time frame: Up 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 zone
  Time frame: up 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 zone
  Time frame: up to one month
  Each participant will have optical coherence tomography angiography and measure differences in retinal foveal avascular zone.
• Changes in retinal capillary density
  Time frame: up to one month
  Each participant will have optical coherence tomography angiography and measure differences in retinal capillary density.

Sponsor's own description

Treatment of diabetic retinopathy (DR) and diabetic macula edema has included panretinal photocoagulation and intra ocular injections of anti-vascular endothelial growth factors (anti-VEGF) agents and steroids. Anti-VEGF therapy is currently the first-line treatment for proliferative diabetic retinopathies; however, this approach is ineffective in more than 30% of patients with diabetic retinal complications. Available evidence shows that subcutaneous (under the skin) injection of octreotide, a somatostatin analog, has potential therapeutic benefits in proliferative diabetic retinopathy (PDR) and diabetic macula edema (DME). This study thus seeks to determine the efficacy and safety of intranasal DDM-octreotide in the treatment of diabetic macula edema in individuals that are considered to be refractory to the current therapeutic options.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.