EUCTR2008-003210-10-DK进行中（未招募）1 期
PHASE II OPEN LABEL, MULTICENTER, PROSPECTIVE,RELATED MACULAR DEGENERATION, COMPARATOR STUDY EVALUATING PF-04523655 VERSUS RANIBIZUMAB TREATMENT OF SUBJECTS WITH CHOROIDAL NEOVASCULARIZATION (MONET STUDY)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
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
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •1. Males and females age 50 years or older with active primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and are naïve to any previous treatment for neovascular AMD. Active CNV is defined as any leakage detected on FFA or OCT.
- •Note: Women of non child bearing potential will be defined as female subjects 50- 60 years of age who are amenorrheic for at least 2 years and have a serum FSH level within the laboratory reference range for postmenopausal women. Female subjects of childbearing potential are eligible for the study but should be willing to use adequate (at least two forms of) contraceptive methods as described below during the treatment period and for 3 months after the last dose of study medication. Male subjects with partners of childbearing potential must agree to use adequate (at least one form of) contraception as described below during the treatment period and for 3 months after the last dose of study medication or be surgically sterile.
- •Acceptable contraceptive methods for female (need at least two):
- •a. Hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs) at least 14 days prior to the first dose of trial medication;
- •b. Abstinence;
- •c. Placement of a copper-containing intrauterine device (IUD);
- •d. Condom with spermicidal foam/gel/film/cream/suppository;
- •e. Tubal ligation;
- •f. Male partner who has had a vasectomy for at least 4 months. Acceptable contraceptive methods for male (need at least one):
- •a. Abstinence;
- •b. Use of condom for males with a vasectomy;
- •c. Without a vasectomy, must use a condom and be instructed that their female partner should use another form of contraception such as an IUD, spermicidal
- •foam/gel/film/cream/suppository, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or tubal ligation if the female partner
- •could become pregnant from the time of the first dose of trial medication until
- •3 months after the last dose.
- •Best corrected visual acuity using ETDRS protocol of 20/40 to 20/320 in the study eye at the baseline visit.
- •Best corrected visual acuity score in the fellow eye of 20/800 or better at the baseline Visit.
- •Note: Only one eye will be treated (study eye) during the duration of the study. In the event both eyes are eligible for study entry the study eye should be selected by the investigator and subject. The non-study eye may be treated with an approved AMD therapy.
- •2. The total area of CNV (including both classic and occult components) encompassed within the lesion must be 50% or more of the total lesion area.
- •3. The total lesion size =12 disc areas.
- •4. Subject has retinal central subfield thickness =250µm measured using Stratus OCT.
- •5. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- •6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of
排除标准
- •1. CNV in either eye of other etiology, eg, ocular histoplasmosis, trauma, or pathologic myopia.
- •2. Any prior treatment for neovascular AMD including but not limited to the following approved or investigational therapies administered locally to the study eye or systemically; verteporfin photodynamic therapy, focal laser photocoagulation, external-beam radiation therapy, transpupillary thermotherapy in the study eye, anti VEGF therapy eg ranibizumab, pegaptanib, bevasiranib, and VEGF trap, intra ocular(eg, triamcinolone, anecortave acetate), peribulbar steroids, vitrectomy, submacular surgery or other surgical intervention for AMD in the study eye.
- •3. Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either 50% or more of the total lesion area or 1 or more disc areas in size.
- •4. Presence of subfoveal scarring.
- •5. Retinal pigment epithelial tear involving the macula in the study eye.
- •6. History of rhegmatogenous retinal detachment or macular hole (any Stage) in the study eye.
- •7. Any concurrent ocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could either (a) require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition; or (b) if allowed to progress untreated, could likely contribute to loss of at least 5 letters (ETDRS) of best corrected visual acuity over the 12-month study period.
- •8. Current active intraocular inflammation (grade trace” or above) or history of idiopathic / autoimmune uveitis in either eye.
- •9. Current infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- •10. Vitreous hemorrhage present in the study eye.
- •11. Spherical equivalent of the refractive error in the study eye demonstrating more than-8 diopters of myopia.
- •12. Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline.
- •13. Uncontrolled glaucoma in the study eye (defined as intraocular pressure of 30 mmHg or more despite treatment with antiglaucoma medications).
- •14. History of glaucoma filtering surgery in the study eye.
- •15. History of corneal transplant in the study eye.
- •16. 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 or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
- •17. Current treatment for active systemic infection.
- •18. History of procedure/surgery with increased risk of thromboembolism such as but not limited to major gastrointestinal, cardiothoracic, gynecological, genitourinary, or orthopedic surgeries 2 months prior to study enrollment (baseline visit).
- •19. History of cerebral vascular accident, myocardial infarction, transient ischemic attacks 6 months prior to study enrollment.
- •20. Inability to obtain fundus photographs, FFA or OCT of sufficient quality to be analyzed and graded by the central reading center.
- •21. Inability to comply with study or follow-up procedures.
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