EUCTR2009-010536-17-FR进行中（未招募）1 期
A Clinical Safety and Efficacy Comparison of NEVANAC® 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients - Macular Edema Incidence/Severity Reduction with NEVANAC®
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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) Patients must be 18 years of age and older, of any race and either sex, who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens into the lens capsule
- •2) History of Type 1 or Type 2 diabetes
- •3) NPDR (mild, moderate or severe) in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale
- •4) Patients must be able to understand and sign an informed consent that has been approved by an Institutional Review Board (IRB)
- •5) Central subfield macular thickness = 320 µm in the study eye prior to cataract surgery as determined by SD-OCT and confirmed by the reading center
- •6) Absence of CME or cystoid abnormalities in the study eye as detected by SD-OCT and confirmed by the reading center
- •7) Absence of clinically significant macular edema (CSME) in the study eye as detected by clinical exam
- •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) Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by reading center or investigator
- •2) Current or previous ocular disease in the study eye that in the opinion of the investigator may confound assessment of the macula, the retina, or central vision, other that diabetic retinopathy
- •3) Focal photocoagulation for the treatment of diabetic macular edema in the study eye within 6 months of the pre-operative baseline visit (Note: peripheral retina treatment for retinal tear or lattice degeneration is permitted)
- •4) Prior panretinal photocoagulation in the study eye
- •5) Planned multiple procedures for study eye during the cataract/IOL implantation surgery (e.g., trabeculectomy, corneal transplant)
- •6) Patients who have received corneal transplants in the study eye
- •7) Patients whose baseline cumulative corneal fluorescein staining score (i.e., sum of scores for all 5 corneal regions) for the study eye is graded as =5, or whose baseline corneal fluorescein staining score in any single region for the study eye is graded as =3
- •8) History of iris atrophy or chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, uveitis, iridocyclitis) in the study eye
- •9) Patients with a visually nonfunctional fellow eye, defined as a best-corrected visual acuity of =35 ETDRS letters or worse (Snellen equivalent 20/200), except when the acuity decrease is caused by a cataract.
- •10) Patients who are immunocompromised (e.g., patients receiving chemotherapy irradiation therapy, patients with AIDS, leukemia, or cachexia) or patients receiving dialysis
- •11) Patients, who in the opinion of the investigator, might be at increased risk of complications from topical NSAIDs including those with current or history of keratoconjunctivitis sicca (dry eye syndrome), neurotrophic keratopathy, lid or orbit abnormalities and collagen vascular disease
- •12) Use of medications known to affect the macula, including hydroxychloroquinine (Plaquenil) and phenothiozines (e.g., thioridazine [Mellaril], chloropromazine [Thorazine]) or supplemental niacin =3 grams/day
- •13) Use of daily doses of systemic steroids and NSAIDS within 7 days prior to surgery (through study exit). Daily doses of aspirin, up to 325 mg, will be permitted. 14) Use of daily doses of topical ocular steroids and NSAIDs in the nonstudy eye through study exit (Note: All topical ocular steroids and NSAIDs must be discontinued 1 day prior to surgery)
- •15) Use of topical ocular NSAIDS and steroids, in the study eye, within 7 days prior to surgery
- •16) Treatment with intraocular or periocular steroids in the study eye within 4 months prior to surgery
- •17) Patients with a known or suspected hypersensitivity to NSAIDs or any component of the study medication
- •18) Use of a topical ophthalmic prostaglandin (e.g., TRAVATAN, XALATAN) within 4 days of surgery through study exit
- •19) The Alcon Medical Monitor may declare any patient ineligible for a valid medical reason.
- •20) Participation in any other clinical study within 30 days of the Baseline examination
- •21) Each patient will have only one eye enrolled in the study
- •22) Females of childbearing potential (those who are not surgically sterilized or post-menopausal) may not participate in the study if any of the following conditions exist: they are breast-feeding; they have a positive urine pregnancy test at screening; they are not willing to undergo a urine pregnancy test upon entering or exiting the study; they intend
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