DIabetic Retinopathy Candesartan Trials.
Condition: Type 1 Diabetes
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: candesartan
Intervention description: 32 mg oral tablet
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1850.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Diabetes mellitus type 1

Summary:

      The primary objective is to determine whether candesartan, compared to placebo reduces the
      progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic
      patients with retinopathy.

      The secondary objective is to determine whether candesartan, compared to placebo, reduces the
      incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic
      retinopathy (PDR) and beneficially influences the rate of change in urinary albumin excretion
      rate (UAER).

      This study is part of the DIRECT Programme also including a primary prevention study of
      diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 2 diabetes.
      The primary objective for all three pooled studies is to determine whether candesartan,
      compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 - 55 years with type 1 diabetes diagnosed before age of 36
             years and in need for continuous insulin treatment within 1 year of diagnosis of
             diabetes are included.

          -  Duration of diabetes for > 1 year and < 20 years with stable diabetic therapy within
             last 6 months.

          -  Patients with untreated resting mean sitting SBP < 130 mmHg, mean sitting DBP < 85
             mmHg and with retinal photograph grading level > 20/10 up to < 47/47 (on ETDRS
             severity scale).

        Exclusion Criteria:

          -  Patients with the following conditions are excluded from participation on the study:

          -  Cataract or media opacity of a degree which precludes taking gradable retinal
             photographs

          -  Angle closure glaucoma, which precludes pharmacological dilatation of the pupil

          -  History or presence of proliferative retinopathy

          -  History or presence of clinical significant macular oedema (CSME)

          -  History or evidence of photocoagulation of the retina

          -  Other retinal conditions which may mask assessment, eg, retinal vein occlusion

          -  Positive micral dipstick test

          -  Presence of secondary diabetes

          -  Pregnant or lactating women or women of child bearing potential not practicing an
             adequate method of contraception

          -  Need of treatment with ACE-inhibitor

          -  Haemodynamically significant aortic or mitral valve stenosis

          -  Known renal artery stenosis or kidney transplantation

          -  Hypersensitivity to study drug

          -  Severe concomitant disease which may interfere with the assessment of the patient, eg,
             malignancy, as judged by the investigator