EUCTR2013-005091-17-IT进行中（未招募）不适用
Variation of choroidal Thickness 15 days after the first ranibizumab intravitreal injection in naïve patients WIth Neovascular age-related macular degeneration: pilot 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）
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.Male or female patients > 50 years of age who have signed an informed consent before any assessment is performed
- •2.Visual impairment predominantly due to neovascular AMD (wet AMD).
- •3.Choroidal neovascularization (CNV) classic or minimally classic; in the new CNV classification type II.
- •4.Naïve eyes with no history of intravitreal injection before the study.
- •5.Active, newly diagnosed, untreated, angiographically documented CNV lesion (ie leakage on fluorescein angiography plus intraretinal, subretinal or sub RPE fluid on OCT) secondary to AMD.
- •6.CNV or sequelae of the CNV (ie, pigment epithelium detachment, subretinal or sub-RPE hemorrhage, blocked fluorescence, macular edema, or subretinal, sub-RPE or intraretinal fluid) involving the center of the fovea.
- •7.The total area of fibrosis comprising less than 50% of the lesion area.
- •8.BCVA score at Baseline between 78 and 23 letters as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at 4 meters, inclusively (approximate Snellen equivalent of 20/32 and 20/320).
- •If both eyes are eligible at Baseline, the investigator will decide the study eye based on his/her clinical judgment. The study eye will be treated with ranibizumab, according to the criteria defined for each treatment group.
- •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 1
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •1.History of hypersensitivity to drugs of similar chemical classes of ranibizumab.
- •2.Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity while on treatment
- •3.Active intraocular inflammation (grade trace or above) in either eye.
- •4.Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye.
- •5. History of uveitis in either eye.
- •6.Structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques.
- •7.Ocular disorders in the study eye that may confound interpretation of results, compromise visual acuity or require medical or surgical intervention during the program period, including cataract, retinal vascular occlusion, retinal detachment, macular hole or choroidal neovascularization of any cause (e.g. ocular histoplasmosis or pathologic myopia).
- •8.Uncontrolled glaucoma in either eye (IOP = 30 mmHg on medication or according to investigator’s judgment).
- •9. Neovascularization of the iris in either eye.
- •10.Evidence of vitreomacular traction in either eye.
- •11. Patients who are monocular or have a BCVA score in the non-study eye (fellow eye) = 24 letters (approximate Snellen equivalent of 20/320) at Basal Visit.
- •12.Any use of eye drops for ocular disease as anti-glaucomatous or antinflammatory drugs.
- •13.History of eye surgery procedure (i.e. cataract surgery, vitrectomy or other surgery in the last 3 months).
- •14.Significant lens opacities.
- •15.History of myocardial infarction or cerebral vascular diseases.
- •16. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, aflibercept.) before the enrollment.
- •17.Known hypersensitivity to Ranibizumab or any component of the Ranibizumab formulation.
- •18.Pregnant or nursing (lactating) women.
- •19.Inability to comply with study procedures.
研究者
相似试验
尚未招募
4 期
A clinical trial to study the effects of Aflibercept in patients with type 2 diabetes mellitus with reduced vision.Diabetic Macular EdemaJPRN-UMIN000051561MMU Mullana Ambala100
已完成
不适用
ongitudinal changes of choroidal thickness in healthy pediatric individuals using swept-source optical coherence tomography(SS-OCT)healthy childrenJPRN-UMIN000027848Saneikai Tsukazaki Hospital60
已完成
不适用
Change of choroidal thickness before and after cataract surgery using enhanced depth imaging spectral-domain optical coherence tomography.Cataract surgery patientsJPRN-UMIN000005920Saneikai Tsukazaki Hospital50
招募中
Unknown
Evaluation of choroidal thickness after corneal cross linkage in keratoconus patientsPACTR202312829415921Alexandria Main University Hospital40
Unknown
不适用
Changes in Choroidal Thickness After Non Penetrating Deep SclerectomyChoroidal ThicknessOpen Angle GlaucomaNon Penetrating Deep SclerectomyNCT03160690Germans Trias i Pujol Hospital20