Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)

Официальное название

A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema

Обзор

A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema

Подробное описание

This is a multicenter, open-label, dose ranging study with 4 cohorts in the dose-escalation portion of the study. An accelerated 3+3 design with parallel and sequential dosing will be used.

Under the escalation design, 12 subjects will be enrolled if there are no DLTs and up to 24 subjects under the condition that exactly 1 of the 3 subjects of every cohort if determined to have a DLT.

Each subject will receive a total of 2 intravitreal injections of OCU200 6 weeks apart.

The DSMB will review the sentinel subject 1 week safety data post dosing in every cohort of all 3 subjects.

Cohort 1: 3+3 participants will receive intravitreal injection of OCU200.

Cohort 2: 3+3 participants will receive intravitreal injection of OCU200.

Cohort 3: 3+3 participants will receive intravitreal injection of OCU200.

Cohort 4: 3+3 participants will receive intravitreal injection of OCU200.

Вмешательства

• Препарат OCU200
  Intravitreal Injection

Первичные конечные точки

• Study Drug-related adverse events (SDAE) [Срок оценки: 24 weeks]
• Treatment-emergent adverse events (TEAEs) [Срок оценки: 24 weeks]
• Serious adverse events (SAEs) [Срок оценки: 24 weeks]

Вторичные конечные точки (6)

• Best-corrected visual acuity (BCVA) [Срок оценки: 24 Weeks (Changes from baseline)]
• Intraocular pressure (IOP) [Срок оценки: 24 weeks(Changes from baseline)]
• Color fundus photography [Срок оценки: 24 Weeks(Changes from baseline)]
• Spectral Domain Optical Coherence Tomography (SD-OCT) [Срок оценки: 24 Weeks(Changes from baseline)]
• Spectral Domain Optical Coherence Tomography Angiography (SD-OCTA) [Срок оценки: 24 weeks (Changes from baseline)]
• Wide-field Fluorescein Angiography (wf-FA) [Срок оценки: 24 weeks (Changes from baseline)]

Критерии участия

Критерии включения

• Diagnosis of Type 1 or Type 2 Diabetes Mellitus
• Decreased visual acuity attributable primarily to DME
• Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:

• ≥ 320 but ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on Heidelberg Spectralis
• ≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus
• BCVA ≤ 78 and ≥ 24 letters on ETDRS chart
• Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging
• No history of prior anti-VEGF injection or history of at least 2 consecutive intravitreal anti-VEGF injection (less than 7 weeks apart) with incomplete resolution of CST within 1 year.

Note: The last anti-VEGF injection must be administered at least six weeks (45 days) prior to the study treatment (Day 1) in the study eye.

Критерии исключения

• Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)
• Uncontrolled hypertension
• Uncontrolled glaucoma
• Concurrent disease in the study eye, other than central-involved DME
• Intravitreal or periocular steroid treatment within 3 months prior to the screening visit
• Any ocular surgery within 3 months prior to the screening visit in the study eye
• Uncontrolled/poorly controlled diabetes (Glycated hemoglobin (HbA1c) ≥ 10%)
• History of retinal detachment in the study eye or other retinal vascular disease in the study eye
• Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit
• Presence of any inherited retinal disease or history of proliferative diabetic retinopathy
• History of Renal disease including stage 3b or worse

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Advanced Research LLC — Deerfield Beach
• Erie Retina Research, LLC — Erie
• Retina Consultants of Texas Research Centers — Bellaire
• Retina Consultants of America — Southlake
• Gundersen Health System — La Crosse

Идентификаторы

NCT: NCT05802329 · OCU200-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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