EUCTR2008-003210-10-BE进行中（未招募）不适用
PHASE II MULTICENTER, PROSPECTIVE, RANDOMIZED, AGE RELATED MACULAR DEGENERATION, COMPARATOR CONTROLLED, DOSE RANGING STUDY EVALUATING PF-04523655 VERSUS RANIBIZUMAB IN THE TREATMENT OF SUBJECTS WITH CHOROIDAL NEOVASCULARIZATION - MONET-study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •1. Males and females age 50 years or older with active primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to agerelated macular degeneration (AMD). Active CNV is defined as any leakage detected on FFA or OCT. The following subjects will be eligible for study enrollment:
- •a. Subjects who are treatment naïve to neovascular AMD (CNV) therapy;
- •b. Subjects previously/ currently receiving chronic CNV therapy (<7 previous injections) who have previously shown a positive response to their therapy in the study eye (anatomically dry retina on previous OCT scan or a 5 letter improvement in VA). These subjects will be eligible to participate in the study if continued treatment is necessitated for their CNV due to reaccumulation of sub retinal fluid eg, Reaccumulation of retinal fluid of at least 50 µm in the central subfield thickness at least 1 month after last treatment will be considered eligible. Note: Female subjects 50- 60 years of age must be amenorrheic for at least 2 years and have a serum FSH level within the laboratory reference range for postmenopausal women.
- •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. Best corrected visual acuity using ETDRS protocol of 20/40 to 20/320 (letter score =73) in the study eye at the screening visit.
- •5. Best corrected visual acuity score in the fellow eye of 20/400 or better (letter score of =19) at the Screening Visit. Note: Only one eye will be treated (study eye) through 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.
- •6. Subject has retinal central subfield thickness =250µm measured using Stratus OCT.
- •7. 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.
- •8. 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 subjects for this age range
排除标准
- •1. Prior treatment with verteporfin photodynamic therapy, external-beam radiation therapy, or transpupillary thermotherapy in the study eye.
- •2. Previous subfoveal focal laser photocoagulation in the study eye.
- •3. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Baseline.
- •4. Previous non response to ranibizumab therapy (See inclusion criterion 1b) in the study eye.
- •5. History of vitrectomy, submacular surgery or other surgical intervention for AMD in the study eye.
- •6. Previous participation in any studies with investigational drugs or treatments administered 1 month preceding Baseline visit such as systemic glucocorticoids, ocular or periocular steroids (eg, triamcinolone, anecortave acetate), antiangiogenic drugs such as pegaptanib (Macugen), ranibizumab (Lucentis), bevacizumab (Avastin)
- •in the study eye.
- •7. 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.
- •8. CNV in either eye of other etiology, eg, ocular histoplasmosis, trauma, or pathologic myopia.
- •9. Presence of subfoveal scarring.
- •10. Retinal pigment epithelial tear involving the macula in the study eye.
- •11. 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.
- •12. Current active intraocular inflammation (grade trace” or above) or history of idiopathic /autoimmune uveitis in either eye.
- •13. Vitreous hemorrhage present in the study eye.
- •14. History of rhegmatogenous retinal detachment or macular hole (any Stage) in the study eye.
- •15. Current infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- •16. Aphakia or absence of the posterior capsule in the study eye. YAG capulotomy in association with posterior intraocular lens implant is permitted.
- •17. Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia.
- •18. Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline.
- •19. Uncontrolled glaucoma in the study eye (defined as intraocular pressure of 30 mmHg or more despite treatment with antiglaucoma medications).
- •20. History of glaucoma filtering surgery in the study eye.
- •21. History of corneal transplant in the study eye.
- •22. 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.
- •23. Current treatment for active systemic infection.
- •24. Inability to obtain fundus photographs, FFA or OCT of sufficient quality to be analyzed and graded by the central reading center.
- •25. Inability to comply with study or follow-up procedures.
- •26. History of gastrointestinal bleeding 2 months prior to study enrollment.
- •27. History of procedure/surgery with increased risk of thromboembolism such as but not limited to major gastrointest
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