Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

NCT06881888 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB-300011278
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Diabetic Macular Edema

Keywords

Diabetic Macular Edema; Intranasal Octreotide; Octreotide; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (7)

• Change in macular central subfield thickness

  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.

  Up to one month.

• Change in best corrected visual acuity

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

  Up to one month.

• Change in microglia on retinal surface

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

  Up to one month

• Changes in retinal peripheral capillary free zone

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

  up to one month

• Changes in retinal foveal avascular zone

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

  up to one month

• Changes in retinal capillary density

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

  up to one month

• Changes in retinal non-perfusion zones

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

  up to one month

Secondary Outcomes (1)

• Changes in serum insulin like growth factor -1 (IGF-1) levels

  up to one month.

Study Arms (2)

Octreotide Arm

ACTIVE COMPARATOR

Participants will receive the investigational drug, DDM-Octreotide, and administering intranasally in one nostril three times a day.

Drug: Octreotide (drug)

Control Group

PLACEBO COMPARATOR

The control group will receive a placebo nasal spray without the active ingredient, DDM-octreotide, and administering intranasally in one nostril three times a day.

Drug: Placebo

Interventions

Octreotide (drug) DRUG

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

Also known as: Octreotide and 1-O-n-Dodecyl-b-D-Maltoyranoside (DDM) (Intravail®)

Octreotide Arm

Placebo DRUG

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

Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range 18-90
• 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.
• Written informed consent is provided.
• Males and females
• Routine laboratory study results with bilirubin, aspartate aminotransferase and/or alanine aminotransferase, and creatinine within normal limits.

You may not qualify if:

• History of difficult to control diabetes or hypertension
• Eyes receiving laser photocoagulation in the last 6 months or intravitreous treatment for diabetic macular edema in the past 3 months.
• Eye having undergone YAG capsulotomy in the last 3 months.
• Having other ocular surgeries in the last 6 months (examples include but not limited to cataract surgery, scleral buckle, trabeculectomies, etc.).
• 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.
• Chronic infectious disease (e.g. HIV, HCV)
• Positive urine β-hCG test day of visit or a serum beta-HCG test within 48 hours prior to the administration of intranasal octreotide.
• Other ocular diseases or fundus diseases
• Patients with a history of intolerance or hypersensitivity to octreotide or use of octreotide in the preceding 2 months.
• Currently taking an anti-inflammatory medication (e.g. anti-inflammatory agents, glucocorticoids or other immune modulating medications);
• 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.
• 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.
• Any degree of hepatic or renal insufficiency that in the Investigator's judgement would pose a safety risk for treatment with octreotide.
• 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.
• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35243, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Octreotide; Pharmaceutical Preparations; DDMS

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Maria Grant, MD, FARVO

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Medawar, MD

CONTACT

256-682-4351; nmedawar@uab.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 18, 2025
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

US (1)