Safety and Efficacy of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery

Официальное название

Early Feasibility Study to Evaluate the Safety and Efficacy of a New Timolol Sustained-Release Intraocular Implant (TimoD) in Participants With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Undergoing Cataract Surgery

Обзор

The goal of this clinical trial is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma or ocular hypertension and requiring cataract surgery. The study is conducted in two stages. The first stage (Stage 1/Phase 1) is intended to study the safety of 3 different doses of the study medication (called TimoD implant). The second stage (Stage 2/Phase 2) of the study is intended to study in greater detail the efficacy and safety of the 3 doses of the TimoD implant in comparison to a standard approved medication, timolol eye drops for 3 years.

Подробное описание

Timolol will be administered using an investigational drug product called the TimoD implant.

The implant will be placed in one eye (the study eye) using an instrument called an injector system (an investigational device). The implant procedure will be performed during cataract surgery.

Stage 1: Three dose levels of the TimoD implant (low, intermediate, and high) will be evaluated in three groups of six participants each. Participants will be assigned sequentially to a treatment group and will receive a single implant containing one of the three dose levels. Participants in Stage 1 will be followed for 1 year.

Stage 2: The same three dose levels of the TimoD implant will be evaluated further. In addition, a fourth treatment group receiving an approved control treatment (timolol eye drops) will be included. Six participants will be randomized to each treatment group. Participants in Stage 2 will be followed for 3 years.

Вмешательства

• Препарат TimoD implant
  Consists of 1 TimoD implant administration in the study eye.
• Устройство Injector system
  This is a CE-marked injector intended for intraocular lens (IOL) delivery. In this study, the injector is used as an"intraocular implant injection system" outside of its scope of intended use.
• Препарат Timolol eye drops 0.5%
  Timolol eye drops will be self-admnistered twice daily in the study eye approximately 12 hours apart throughout the study

Первичные конечные точки

• Stage 1: Number (%) of participants experiencing adverse events [Срок оценки: From Screening (up to Day -41) to end of stage 1 (Month 13)]
• Stage 1: Number (%) of participants experiencing adverse events of special interest (AESI) [Срок оценки: From Screening (up to Day -41) to end of stage 1 (Month 13)]
• Stage 2: Proportion of responders defined as an IOP decrease of 20% or more between baseline and Month 3 (8 AM IOP) [Срок оценки: Month 3]
• Stage 2: Proportion of time-matched responders defined as an IOP decrease of 20% or more between baseline and Month 3 (8 AM and 10 AM) [Срок оценки: Month 3]

Критерии участия

Критерии включения

• Capable of giving signed informed consent.
• In good general and mental health without ongoing clinically significant abnormalities in medical history.
• Open-angle glaucoma or ocular hypertension and age-related cataract eligible for intra-capsular IOL placement.
• Successful, uncomplicated cataract surgery

Критерии исключения

• Subjects with a history of hypersensitivity or contraindications to β- blockers.
• Participants using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure
• Significant risks caused by washout of ocular hypotensive medications.
• Clinically significant ocular pathology other than OHT, glaucoma and cataract.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Panama · 1 центр

• Panama Eye Center — Panama City

Идентификаторы

NCT: NCT07036510 · EyeD-010-006 · U1111-1317-3395

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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