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
- Conditions
- Mild to moderate non-proliferative diabetic retinopathyTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2004-002249-11-IT
- Lead Sponsor
- BAUSCH&LOMB - IOM S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to demonstrate that the oral therapy with Proendotel 100 mg three times/per day given for 24 months, is superior to placebo in the arrest of progression of non-proliferative retinopathy in patients with diabetes of type I and II (insulin or non-insulin dependent);Secondary Objective: to evaluate the effects of Cloricromene hydrochloride on visual acuity and to evaluate the effects of Cloricromene hydrochloride on changes of macular edema (presence and severity) and retinal thickness; to evaluate the safety and tolerability profile of Cloricromene hydrochloride.;Primary end point(s): To demonstrate that the treatment with Cloricromene hydrochloride is superior to placebo in the arrest of progression of non-proliferative retinopathy, observed with the Fundus Oculi photograph and with Fluorangiography
- Secondary Outcome Measures
Name Time Method