Építés alatt – nem éles oldal
Belépés
Még nem keres résztvevőt itt: Kína4. fázis

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)

A legfontosabb adatok

Ki végzi
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Hol
Beijing, Foshan, Hangzhou, Harbin, Jiaxing, Jilin City, Jinan, Kunming, Nanchang, Nanjing, Shanghai, Taiyuan, Tianjin, Weifang, Wuhan, Xi'an, Xianyang és Zhengzhou (Kína)Mind a 20 helyszín megnézése
Azonosító
Állapot
Toborzás még nem indult
Fázis
4. fázis
Résztvevők
174 fő, tervezett
Kezdés
2026. jan. 1.
Várható befejezés
2027. dec. 31.
A vizsgálat típusa
Beavatkozással járó, 2 csoport
A vizsgált kezelések
  • Aflibercept Intravitreous Injection
A regiszteradat frissítve
2026. január 26.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat 50 éves vagy idősebb felnőtteket keres, akiknek tüneteket okozó polipoid chorioidea vasculopathiájuk (PCV) van a makulában, és akiket ezzel még nem kezeltek.

Életkor
50 éves vagy idősebb
Nem
Nemtől függetlenül bárki részt vehet.
A betegség stádiuma
Tüneteket okozó PCV a makulában: az ICGA képalkotáson aktív, polipszerű elváltozások látszanak, és a makula körüli 6.0 mm-es ETDRS zónán belül kóros újonnan képződött erek (CNV) vannak. A vizsgált szem látása 78–24 ETDRS betű.
Korábbi kezelés
Az 1. nap előtt nem kaphatott korábban anti-VEGF gyógyszert, kortikoszteroidot, lézerkezelést vagy fotodinámiás terápiát (PDT), és nem kaphatott PCV-re engedélyezett gyógyszert sem.

A részvétel fő kizáró okai

  • Terhesség vagy szoptatás
  • A kezelés ellenére 160 feletti (felső érték) vagy 95 feletti (alsó érték) vérnyomás
  • Allergia a vizsgált gyógyszerre vagy annak összetevőire
  • A vizsgált szemben más, a látást befolyásoló szembetegség, például nem kontrollált glaukóma vagy ideghártya-leválás
  • Szemgyulladás vagy szemfertőzés a szűrés előtti 12 héten belül

A regiszter feltételei, szó szerint

Mind a 16 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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
  • 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
  • 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
  • Allergy or hypersensitivity to any of the compounds/excipients in the study interventions formulations
  • 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
  • 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: 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
  • 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
  • Pregnant or breastfeeding
  • Ocular Exclusion Criteria for Study Eye: Retinal pigment epithelial tear involving the macula on study Day 1

Helyszínek itt: Kína

  • Beijing HospitalBeijing, KínaContact: Hong DaiToborzás még nem indult
  • Beijing Tongren Hospital CMUBeijing, KínaContact: Zhaoyang WangToborzás még nem indult
  • The Second People's Hospital of FoshanFoshan, KínaContact: Xiangbin KongToborzás még nem indult
  • The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhou, KínaContact: Zhiqing ChenToborzás még nem indult
  • The First Affiliated Hospital of Harbin Medical UniversityHarbin, KínaContact: Hong ZhangToborzás még nem indult
  • Jiaxing Hospital of T.C.MJiaxing, KínaContact: Lijun JiangToborzás még nem indult
  • The Second Norman Bethune Hospital of Jilin UniversityJilin City, KínaContact: Jun XiaoToborzás még nem indult
  • Shandong Provincial HospitalJinan, KínaContact: Han ZhangToborzás még nem indult
  • The First Affiliated Hospital of Kunming Medical UniversityKunming, KínaContact: Ling YuanToborzás még nem indult
  • Affiliated Eye Hospital of Nanchang UniversityNanchang, KínaContact: Zhipeng YouToborzás még nem indult
  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)Nanjing, KínaContact: Weiwei ZhangToborzás még nem indult
  • Eye ENT Hospital of Fudan UniversityShanghai, KínaContact: Wei LiuToborzás még nem indult
  • Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineShanghai, KínaContact: Xiaodong SunToborzás még nem indult
  • Shanxi Eye HospitalTaiyuan, KínaContact: Guohong ZhouToborzás még nem indult
  • Tianjin Eye HospitalTianjin, KínaContact: Mei HanToborzás még nem indult
  • Affiliated Hospital of Shandong Second Medical UniversityWeifang, KínaContact: Aijun DengToborzás még nem indult
  • Renmin Hospital of Wuhan UniversityWuhan, KínaContact: Xuan XiaoToborzás még nem indult
  • Xi' AN No.1 HospitalXi'an, KínaContact: Huiqin LuToborzás még nem indult
  • The First People's Hospital of XianyangXianyang, KínaContact: Min WangToborzás még nem indult
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, KínaContact: Liping DuToborzás még nem indult

A vizsgálatról

Mit akar kideríteni a vizsgálat

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:

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • Arm AEgyéb csoport

    All enrolled patients meeting eligibility will receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). Subsequent reinjections will be given according to the changes in patients' disease activity. If no retreatment criteria are met, no additional injections will be given, and patients will undergo follow-up examinations (including ETDRS visual acuity, findus photography, OCT-A and SD-OCT) every 4 weeks until week 48. Patients will return to the Clinical Research Unit (CRU) for an end-of-study (EOS) visit at week 52.

    Kezelés: Aflibercept Intravitreous Injection

  • Arm BEgyéb csoport

    All enrolled patients meeting eligibility will receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). All patients in this group will undergo an examination at week 12, including ETDRS visual acuity, fundus photography, OCT-A and SD-OCT. Subsequent treatment regime will depend on disease activity. If disease is considered inactive, the next dose will occur at week 16 (8 week interval from last dose at week 8) and subsequent dose and visit will be extended by 4 weeks up to a maximum interval of 20 weeks and minimum interval of 8 weeks between treatments if disease remains quiescent. If signs of activity are noted at any visit point, visit interval will be reduced by 4 weeks. The last dose will be administered no later than week 48. Patients will return to the CRU for an EOS visit at week 52.

    Kezelés: Aflibercept Intravitreous Injection

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 13.
A regiszteradat frissítve
2026. január 26.