DIabetic Retinopathy Candesartan Trials

Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.

The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 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 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 1 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 37 - 75 years with type 2 diabetes diagnosed at age of 36 years or thereafter.
• 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 and mean sitting DBP < 85 or treated resting mean SBP < 160 mmHg and mean sitting DBP < 90 mmHg 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 in 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 of 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