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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002249-11-IT
Enrollment
Unknown
Registered
2004-10-05
Start date
2004-09-20
Completion date
Unknown
Last updated
2012-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate non-proliferative diabetic retinopathy

Interventions

Trade Name: PROENDOTEL*30CPS 100MG Pharmaceutical Form: Gastro-resistant capsule, hard CAS Number: 68206-94-0 Concentration unit: mg milligram(s) Concentration number: 100-

Sponsors

BAUSCH&LOMB - IOM S.P.A.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Written informed consent obtained. Male or female patients aged > = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026