EUCTR2019-002475-34-DE进行中（未招募）1 期
Efficacy, Safety and Pharmacokinetics of 3 Doses of REC 0/0559 Eye Drops for the Treatment of Stage 2 (Moderate) and 3 (Severe) Neurotrophic Keratitis in Adult Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Be a male or female aged = 18 years
- •2. Have Stage 2 moderate (PED) or Stage 3 severe (corneal ulcer) NK involving only 1 eye (study eye) and of at least 2 weeks duration.
- •3. Have no objective clinical evidence of improvement in the PED or corneal ulceration within the 2 weeks before the Screening Visit despite use of conventional non-surgical treatment.
- •4. Have decreased corneal sensitivity (= 4 cm using the Cochet-Bonnet aesthesiometer) within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant.
- •5. Have a BCDVA score = 75 ETDRS letters in the study eye, due to NK.
- •Refer to the exhaustive list of inclusion criteria in the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •Individuals meeting any of the following criteria at the Screening Visit are ineligible to participate in this study.
- •For the study eye:
- •1. Have severe blepharitis and/or severe meibomian gland disease in the study eye.
- •2. Have severe vision loss in the study eye with no potential for visual improvement in the opinion of the investigator as a result of the study treatment.
- •3. Have evidence of corneal ulceration/melting involving the posterior third of the corneal stroma, or perforation in the study eye.
- •4. Have a history of corneal transplantation in the study eye, performed less than 12 months prior screening.
- •5. Have had prior surgical procedures for the treatment of NK (eg,
- •complete tarsorrhaphy, conjunctival flap, etc.) except partial
- •tarsorrhaphy if done more than 6 months prior to screening visit (with investigators assessment documenting that the eye lids are functioning sufficiently to ensure adequate protection of the eye) and amniotic membrane transplantation, if at least 2 weeks after the membrane has disappeared within the area of the PED or corneal ulcer (and at least 6 weeks after the procedure) in the study eye.
- •Patients previously treated with Botox® (Botulinum toxin) injections
- •used to induce pharmacologic blepharoptosis are eligible for enrolment only if the last injection was given at least 3 months before the Screening Visit.
- •6. Have an uncontrolled glaucoma at the Screening Visit
- •7. Have Stage 2 or 3 NK or perforation (for the fellow eye).
- •8. Have had prior treatment with Oxervate (cenegermin eye drops).
- •Refer to the exhaustive list of exclusion criteria in the protocol.
研究者
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