Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study

Официальное название

A Phase 3b, Multicenter, Open-Label, Extension Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study

Обзор

Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants with Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study

Вмешательства

• Препарат OTX-TKI
  Intravitreal Injection of OTX-TKI

Первичные конечные точки

• Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144 [Срок оценки: from Baseline (Day 1) through Week 144]
• Proportion of participants with severe vision loss (defined as ≥ 30 Early Treatment Diabetic Retinopathy Study [ETDRS] letters loss) from Baseline (Day 1) through Week 144 [Срок оценки: from Baseline (Day 1) through Week 144]

Критерии участия

Критерии включения

• Participants with a diagnosis of nAMD in the study eye who successfully completed Study OTX-TKI-2023-AMD-301 through Week 104 or Study OTX-TKI-2023-AMD-303 through Week 96
• Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fundus imaging
• Are able and willing to comply with all study requirements and visits
• Have provided written informed consent

Критерии исключения

• Have significant intraocular or periocular infection (bacterial, viral, or fungal) in the study eye within 3 months prior to Day 1
• History of intraocular inflammation in the study eye
• Have evidence of a rhegmatogenous retinal detachment or visually significant/severe epiretinal membrane, macular hole, tear of the retinal pigment epithelium in the macula, or other macular
• Presence of an intercurrent illness or condition that in the opinion of the Investigator, may place the participant at an unacceptable risk, preventing the participant from completing the study or confound the interpretation of study results
• Female participants who are pregnant (had a positive urine test at the Baseline visit \[Day 1\]) or breastfeeding or intend to become pregnant during the study, who are unwilling to use 2 forms of highly effective contraception from baseline until they exit the study or at least 3 months after the last study treatment, whichever is later.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 8 центров

• California Retina Consultants (CRC) — Bakersfield
• California Retina Consultants (CRC) — Santa Barbara
• Retina Group of New England — Waterford
• Retina Group of Florida - Fort Lauderdale — Fort Lauderdale
• Cumberland Valley Retina Associates — Hagerstown
• Mid Atlantic Retina Specialists — Hagerstown
• Palmetto Retina Center — West Columbia
• Austin Retina Associates — Austin

Идентификаторы

NCT: NCT07516132 · OTX-TKI-2025-AMD-301 · SOL-X

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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