Evaluation of the Safety, Efficacy, Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Diagnosed With Open Angle Glaucoma or Ocular Hypertension

Официальное название

Prospective, Multi-Center, Open-Label, Non-Randomized, Multi-Arm Study to Evaluate the Safety, Efficacy, and Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Implanted With a Posterior Chamber Intraocular Lens (PC-IOL) and Diagnosed With Mild to Moderate Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Обзор

The goal of this clinical trial is to learn if two different doses of the SpyGlass Bimatoprost-Drug Ring System (BIM-DRS) work to treat adult pseudophakic patients with either glaucoma or ocular hypertension. The main question it aims to answer is: Does the BIM-DRS lower the pressure inside the eye to treat glaucoma or ocular hypertension? Researchers will compare two different doses of the BIM-DRS implanted either with a pre-existing commercially available monofocal intraocular lens (IOL) or concurrently with the SpyGlass IOL (IOL with silicone pads (no drug)). Participants will: * Upon providing informed consent and successfully completing the screening visit, stop taking their IOP lowering medications in the eye to be treated. * Complete a baseline visit to further evaluate eligibility in the study eye. * Undergo surgery to implant the BIM-DRS (BIM-DRS and SpyGlass IOL for Cohorts 3 and 4). Only one eye of each participant will be treated. * Complete post-operative follow-up visits for evaluation at Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36 (last study visit).

Вмешательства

• Препарат BIM-DRS Low Dose
  Bimatoprost-Drug Ring System Low Dose
• Препарат BIM-DRS High Dose
  Bimatoprost-Drug Ring System High Dose
• Устройство SpyGlass IOL with silicone pads (no drug)
  SpyGlass Intraocular Lens with silicone pads (no drug)

Первичные конечные точки

• Mean IOP change from Baseline (mmHg) [Срок оценки: Postoperative Week 2, Week 6, and Month 3.]

Вторичные конечные точки (5)

• Mean IOP (mmHg) [Срок оценки: Postoperative Week 2, Week 6, and Months 3, 6, 12, 18, 24, 30, and 36]
• Mean IOP change from Baseline (mmHg) [Срок оценки: Postoperative Months 6, 12, 18, 24, 30, and 36]
• Mean IOP change from Baseline [Срок оценки: Postoperative Months 6, 12, 18, 24, 30, and 36]
• Time to postoperative introduction of additional IOP-lowering medication [Срок оценки: Postoperative Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36]
• Number of additional IOP-lowering medications introduced [Срок оценки: Postoperative Months 3, 6, 12, 18, 24, 30, and 36]

Критерии участия

Критерии включения

• Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
• Pseudophakic or planned removal of cataract
• Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception

Критерии исключения

• Uncontrolled systemic disease
• History of incisional/refractive corneal surgery
• Any glaucoma diagnosis other than OHT, open-angle, or pigmentary glaucoma
• History of incisional glaucoma surgery
• Other ocular diseases, pathology, or conditions

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07641296 · SGP-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗