Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change in macular central subfield thickness [Срок оценки: Up to one month.]
• Change in best corrected visual acuity [Срок оценки: Up to one month.]
• Change in microglia on retinal surface [Срок оценки: Up to one month]
• Changes in retinal peripheral capillary free zone [Срок оценки: up to one month]
• Changes in retinal foveal avascular zone [Срок оценки: up to one month]
• Changes in retinal capillary density [Срок оценки: up to one month]
• Changes in retinal non-perfusion zones [Срок оценки: up to one month]

Вторичные конечные точки (1)

• Changes in serum insulin like growth factor -1 (IGF-1) levels [Срок оценки: up to one month.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• Patients with a current known infection or who are acutely ill.
• Patients with an autoimmune disease (i.e., Lupus, Rheumatoid Arthritis).
• Patients with thyroid disorders unless euthyroid at screening.
• Patients with cancer not in remission.
• Inability to tolerate or intranasal administration of investigated drug and experiences severe irritation or sneezing.
• Inability to attend scheduled study visits, plans for family relocation during the study, or any other criteria that the investigator may determine to be associated with inability to complete the study.
• Limited mental capacity rendering the subject unable to provide written informed consent or comply with evaluation procedures.
• History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
• Use of any investigational drug within 30 days prior to the baseline visit.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Alabama at Birmingham — Birmingham

Идентификаторы

NCT: NCT06881888 · IRB-300011278

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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