A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis

Официальное название

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis

Обзор

This is a Phase II, double-blind, placebo-controlled study to evaluate the safety and efficacy of STSP-0902 ophthalmic solution in patients with neurotrophic keratitis (NK). The study plans to enroll 48 patients with Mackie Stage 2 or 3 NK affecting one or both eyes. Eligible subjects will be randomized 1:1:1 into three dosing groups. Each dosing group will follow a drug-placebo allocation (12 active: 4 placebo). Treatment involves topical ocular administration for 8 weeks. Subjects who are not healed after the 8 weeks of masked treatment period will be permitted to receive standard of care during the follow-up period

Вмешательства

• Препарат STSP-0902 ophthalmic solution
  Eye drop, 3 times daily for 8 weeks
• Препарат STSP-0902 ophthalmic solution
  Eye drop, 6 times daily for 8 weeks
• Препарат STSP-0902 Placebo
  Eye drop, 3 or 6 times daily for 8 weeks

Первичные конечные точки

• Incidence of Adverse Events [Срок оценки: Screening to Week 10]
• Ocular Symptoms and Signs [Срок оценки: Screening to Week 10]
• Intraocular Pressure (IOP) Measurements [Срок оценки: Screening to Week 10]
• Slit-Lamp Examinations [Срок оценки: Screening to Week 10]
• Optical Coherence Tomography (OCT) Results [Срок оценки: Screening to Week 10]
• Clinically Significant Changes in Vital Signs [Срок оценки: Screening to Week 10]
• Clinically Significant Changes in Physical Examinations [Срок оценки: Screening to Week 10]
• Clinically Significant Changes in 12-Lead ECGs [Срок оценки: Screening to Week 10]
• Clinically Significant Laboratory Abnormalities [Срок оценки: Screening to Week 10]

Вторичные конечные точки (8)

• Corneal Healing [Срок оценки: Baseline to Week 10]
• Corneal Sensitivity [Срок оценки: Baseline to Week 10]
• Patients with Deterioration [Срок оценки: Baseline to Week 10]
• Best Corrected Visual Acuity (BCVA) [Срок оценки: Baseline to Week 8]
• Tear Secretion [Срок оценки: Baseline to Week 8]
• Visual Quality of Life Assessed Using the NEI-VFQ-25 [Срок оценки: Baseline to Week 8]
• STSP-0902 concentration [Срок оценки: Baseline to Week 10]
• Incidence of positive detection of anti-STSP-0902 antibodies [Срок оценки: Baseline to Week 10]

Критерии участия

Критерии включения

• Male or female patients aged between 18 to 85 years (inclusive).
• Diagnosed with NK in one or both eyes, with the study eye classified as Mackie Stage 2 (PED) or Stage 3 (corneal ulcer), and with a maximum corneal defect diameter ≥2 mm.
• Reduced or absent corneal sensitivity in the defect area and at least 1 adjacent corneal quadrant, confirmed by: ≤40 mm using the aesthesiometer or cotton swab test demonstrating marked reduction or absence of corneal sensitivity.
• NK duration >2 weeks in the study eye, as confirmed by the investigator based on medical history.
• No improvement in the study eye for ≥7 days prior to randomization.
• Effective non-pharmacological contraception used by the subject (and partner, if applicable) throughout the trial and for 3 months after the last dose, with no plans for pregnancy or gamete donation.
• Voluntarily sign informed consent, with willingness and ability to comply with study procedures, follow-ups, and assessments.

Критерии исключения

• Any eye with corneal stromal ulceration involving >1/3 of corneal thickness or at risk of corneal melting/perforation.
• Active infection (bacterial, viral, fungal, amoebic, chlamydial) in any eye, or active ocular inflammation unrelated to NK.
• Study eye with other ocular diseases requiring topical medication apart from the prescribed adjunctive treatments during the trial.
• Bilateral vision loss severely impacting daily life, as assessed by the investigator.
• Study eye with Schirmer I test ≤3 mm/5 minutes.
• Severe lagophthalmos, eyelid margin disease, or meibomian gland dysfunction in the study eye that may impair corneal healing or trial outcomes.
• Study eye with any surgery within 3 months prior to randomization (including corneal/non-corneal surgeries affecting trial assessments, except surgeries related to NK etiology), or planned ocular surgery during the trial.
• Study eye with prior surgical intervention for NK (e.g., tarsorrhaphy, conjunctival flap) that may confound efficacy assessments, or amniotic membrane transplantation within 6 weeks prior to randomization.
• Study eye with botulinum toxin injections to the levator muscle within 3 months prior to randomization or planned during the trial.
• Requirement to wear contact lenses during the trial.
• History of inefficacy or poor response to nerve growth factor (NGF) eye drops in any eye.
• Use of autologous serum eye drops, deproteinized calf blood extracts, or other growth factor-containing ocular medications in the study eye(s) planned during the trial.
• Use of NSAIDs, or corticosteroids in the study eye within 1 week prior to randomization or planned during the trial.
• Use of neurotoxic drugs (e.g., antipsychotics, antiepileptics, antihistamines) or systemic immunosuppressants within 4 weeks prior to randomization or planned during the trial, excluding those who have been using it stably for at least 4 weeks before enrollment.
• Poorly controlled systemic or ocular conditions (e.g., diabetic retinopathy, uveitis, autoimmune diseases, malignancies, psychiatric disorders) that may confound efficacy assessments or compliance, as judged by the investigator.
• Known hypersensitivity to the study drug, its excipients, or components of trial-related ophthalmic tests (e.g., fluorescein).
• History of drug abuse or alcohol dependence.
• Participation in another interventional trial (drugs, devices, or vaccines) within 3 months prior to randomization or planned during this trial.
• Female subjects who are pregnant, breastfeeding, or test positive for serum pregnancy; or who are failure to use effective contraception for 2 weeks prior to screening, during the trial, or for 3 months post-dosing.
• Difficulty administering eye drops, venous blood sampling, or history of needle phobia/vasovagal syncope.
• Any other condition deemed unsuitable for trial participation by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shandong First Medical University Affiliated Eye Hospital — Цзинань

Идентификаторы

NCT: NCT06975748 · STSP-0902-02-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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