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Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

NCT06881888 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Octreotide (drug)

Participants will administer the DDM-octreotide nasal spray without priming in one nostril three times a day.

DRUG

Placebo

Participants will administer the placebo nasal spray without priming in one nostril three times a day.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Maria Grant, MD, FARVO · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06881888 on ClinicalTrials.gov