Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

StatusWithdrawn
PhasePhase 1
Started

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Record History

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  1. Withdrawn before enrolling Sponsor's reason: Project terminated due to loss of sponsor funding following the dissolution of AMD Opti. Show 4 more changesShow less
    • Enrollment target: estimated 60 to confirmed 0
    • Primary completion date changed from estimate of Dec 2027 to Oct 8, 2026
    • Eligibility criteria expanded, about 29 words
    • Site contact updated
  2. Primary and study completion dates: Dec 2026 to Dec 2027
    • Start date: Aug 31, 2025 to Aug 31, 2026
    • Collaborators shortened, about 2 words
    v3
  3. Start date: May 2025 to Aug 31, 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06881888
Lead Sponsor University of Alabama at Birmingham
Conditions
(from sponsor)		 Diabetic Macular Edema
Related terms Diabetic Retinopathy
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov