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.

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

During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment.

Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.