Double blind, randomized, multicenter, placebo-controlled, parallel-group design clinical trial of the efficacy and tolerability of cloriclomene hydrochloride capsules 100 mg TID in diabetic patients with mild to moderate non-proliferative retinopathy

BAUSCH&LOMB - IOM S.P.A.0 个研究点开始时间: 2004年10月5日最近更新: 2012年12月10日

适应症

试验速览

暂无简介。

•Written informed consent obtained. Male or female patients aged > = 18 years and < = 75 years; Clinical diagnosis of insulin dependent diabetes mellitus (IDDM, type 1) or non-insulin dependent diabetes mellitus (NIDDM, type 2) treated with insulin or oral anti-hypoglycemic drugs; Mild (level 35) or moderate (level 43 A-B and 47 A-D) non-proliferative diabetic retinopathy (38) in at least one eye, as determined by using ETDRS standard fields 30-degree Stereoscopic Color Fundus Photography; Glycosylated hemoglobin (HbA1c) levels < 10% and Patients with IDDM able to self-measure their blood glucose levels at home and to adjust their insulin dosage to maintain blood glucose control; A Best Corrected Visual Acuity score of 75 or more (20/32 or better) as measured by using ETDRS visual protocol (39) Absence of macular edema or presence of non-clinically significant diabetic macular edema; Media clarity, papillary dilation and patient cooperation sufficient to allow stereoscopic cooperation sufficient to allow stereoscopic 30? fundus photographs of adequate quality in at least one eye that meets the above criterion on visual acuity; Blood pressure controlled (DBP < 100 mmHg and SBP < 160 mmHg with or without medication);
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•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

•History of photocoagulation for diabetic macular edema in the study eye except focal photocoagulation at least 6 months before. History of any pan retinal photocoagulation for diabetic macular edema in the study eye; Presence of clinically significant diabetic macular edema Current vitreous or preretinal hemorrhage; Concomitant treatment with hemorrheological, vasoactive drugs and antithrombotics except acetylsalicylic acid; History of hypersensitivity to fluorescin; Patients with clinical history of diathesis and hemorrhage disease; Pregnant or lactating females or females at risk of pregnancy contraception.i.e. those intending to become pregnant or those not demonstrating adequate contraception. Patients who received any investigational new drug within the last 12 months; Surgery or trauma within the past 12 months; Planned surgical intervention within 12 months from enrolment.

发起方

BAUSCH&LOMB - IOM S.P.A.