A Prospective, Multicenter, Open-label, Randomized Clinical Trial to Evaluate the Efficacy, Durability, and Safety of Aflibercept 8mg in Different Treatment Regimens in Chinese Patients With Polypoidal Choroidal Vasculopathy (PCV)

Обзор

The goal of this clinical trial is to investigate the efficacy, durability, and safety of aflibercept 8 mg in treating Polypoidal Choroidal Vasculopathy (PCV) in Chinese naive patients. The main questions it aims to answer are: 1. What is the change in Best Corrected Visual Acuity (BCVA) at Week 52 from baseline in different treatment regimens? 2. What proportion of patients achieve sustained disease control after receiving the loading dose? Participants will: * Receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). * In Arm A: * Undergo reinjections based on disease activity, with follow-up examinations every 4 weeks until week 48. * Return for an end-of-study visit at week 52. * In Arm B: * Undergo an examination at week 12 and subsequent treatments based on disease activity, with a maximum interval of 20 weeks and a minimum interval of 8 weeks between doses if the disease remains inactive. * Return for an end-of-study visit at week 52. This study will assess the efficacy, safety and durability of aflibercept 8mg in these 2 regimens.

Вмешательства

• Препарат Aflibercept Intravitreous Injection
  Patients will be given IVT injection(s) of IMP using standard injection techniques.

Первичные конечные точки

• Best Corrected Visual Acuity (BCVA) change at Week 52 after baseline in different treatment regimens. [Срок оценки: up to 52 Weeks]

Вторичные конечные точки (10)

• Percentage of patients gaining >15, >10, or ≥5 letters in BCVA after baseline [Срок оценки: up to 52 Weeks]
• Percentage of patients achieving complete polypoidal lesion regression at Weeks 52 [Срок оценки: up to 52 Weeks]
• Percentage of patients with no active polypoidal lesion at Week 52 [Срок оценки: up to 52 Weeks]
• Change from baseline in central subfield thickness (CST) at Week 12 and 52. [Срок оценки: up to 12 and 52 Weeks]
• BCVA change from baseline at Week 12 [Срок оценки: up to 12 Weeks]
• Percentage of patients achieving Q8W, Q12W, and Q16W treatment intervals at Week 52 in Arm B. [Срок оценки: up to 52 Weeks]
• Percentage of patients achieving Q20W of last assigned interval at Week 52 in Arm B. [Срок оценки: up to 52 Weeks]
• Percentage of patients achieving ≥12-week, ≥16-week and ≥20-week treatment intervals after completing loading doses in Arm A. [Срок оценки: up to 52 Weeks]
• Total number of intravitreal injections administered through Week 52 in both arms. [Срок оценки: up to 52 Weeks]
• Incidence and severity of ocular & non-ocular adverse events. [Срок оценки: up to 52 Weeks]

Критерии участия

Критерии включения

• Patients who fully understand the content, process, and possible AE of the study and capable of giving written informed consent form.
• Male or female, age ≥ 50 years, at the time of signing the informed consent form.
• Women of childbearing potential (WOCBP) must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1% (see Appendix 1) with a barrier contraceptive (such as condom) during the study and for 4 months after discontinuation of study treatment. Women are considered not of childbearing potential if they are surgically sterile (i.e., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or > 1 year postmenopausal. WOCBP must have negative results of pregnancy test at screening and must not be pregnant, breast feeding, lactating, or planning to become pregnant, breast feed or donate ova during the study and for 4 months after discontinuation of study treatment.
• All male participants with female partners of childbearing potential must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1% (see Appendix 1) with a barrier contraceptive (such as condom), and must agree to abstain from sperm donation during and for 4 months after participation in the study.
• Ocular Inclusion Criteria for Study Eye: Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis.
• Ocular Inclusion Criteria for Study Eye: Confirmed diagnosis, by the investigator, of symptomatic macular PCV defined by the following: a. Active macular polypoidal lesions shown by ICGA, AND presence of CNV involving the macula area within the 6.0 mm ETDRS zone as identified by the investigator using multimodal images. b. BCVA scores of 78\~24 ETDRS letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters on study Day 1 Note: If both eyes meet the inclusion criteria, the eye with the worst visual acuity (VA) at the screening visit will be designated as the study eye. If both eyes have the same VA, the Investigator and patient will determine the study eye.

Критерии исключения

• Treatment with investigational therapy (anti-VEGF, corticosteroid, laser photocoagulation, panretinal or macular, and PDT) or approved medications for PCV treatment prior to initiation of study treatment on study Day 1.
• Allergy or hypersensitivity to any of the compounds/excipients in the study interventions formulations.
• Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg). Participants may be treated with up to 3 agents known to have anti-hypertensive effects for arterial hypertension to achieve adequate blood pressure control. This limit applies to drugs that could be used to treat hypertension even if their primary indication in the participant was not for blood pressure control. Any recent changes in medications known to affect blood pressure need to be stable for 12 weeks prior to screening.
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect interpretation of the results of the study, or renders the participant at high risk for treatment complications.
• Any other conditions that the Investigator considers may affect the patients' informed consent or adherence to the study protocol, completion of the test according to the study procedure, or the patients' participation in the test may affect the test results or their own safety.
• Pregnant or breastfeeding.
• Ocular Exclusion Criteria for Study Eye: Any history or presence of macular pathology unrelated to PCV affecting vision or contributing to the presence of macular hemorrhage, IRF, or SRF.
• Ocular Exclusion Criteria for Study Eye: Retinal pigment epithelial tear involving the macula on study Day 1.
• Ocular Exclusion Criteria for Study Eye: On FA/ fundus photograph (FP): a. Subretinal hemorrhage of >4 macular photocoagulation study disc area and/or that involves the fovea b. Fibrosis or atrophy of >50% of the total lesion area and/or that involves the fovea
• Ocular Exclusion Criteria for Study Eye: Any concurrent intraocular condition (e.g., amblyopia, aphakia, retinal detachment, cataract, DR or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study a. Current vitreous hemorrhage on study Day 1 b. Uncontrolled glaucoma c. Any cataract surgery or treatment for complications of cataract surgery with steroids or YAG laser capsulotomy within 3 months prior to study Day 1 d. Any other intraocular surgery (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy) e. Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases • Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye within 4 weeks of the screening visit f. Any intraocular inflammation/infection in either eye within 12 weeks of the screening visit g. History of idiopathic or autoimmune uveitis in the study eye.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 20 центров

• Beijing Hospital — Пекин
• Beijing Tongren Hospital, CMU — Пекин
• The Second People's Hospital Of Foshan — Foshan
• The First Affiliated Hospital Of Harbin Medical University — Харбин
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Renmin Hospital Of Wuhan University — Ухань
• Jiangsu Province Hospital , The First Affiliated Hospital with Nanjing Medical University — Нанкин
• Affiliated Eye Hospital of Nanchang University — Nanchang
• … и ещё 12 центров

Идентификаторы

NCT: NCT07365371 · 23106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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