Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06881888
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Octreotide (drug) — DRUG
    Participants will administer the DDM-octreotide nasal spray without priming in one nostril three times a day.
  • Placebo — DRUG
    Participants will administer the placebo nasal spray without priming in one nostril three times a day.

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Octreotide Arm
    Participants will receive the investigational drug, DDM-Octreotide, and administering intranasally in one nostril three times a day.
  • Placebo Comparator: Control Group
    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.

Primary Outcome Measure

Change in macular central subfield thickness [ Time Frame: Up to one month. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35243
Nicholas Medawar, MD
[email protected]
256-682-4351
Maria Grant, MD, FARVO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
The University of Alabama at Birmingham· Birmingham, AL

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