Barr CC Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive insulin therapy, by The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. N. Engl. J. Med 342:381-9, 2000. Surv Ophthalmol. 2001 Mar-Apr;45(5):459-60.
Berthet P, Farine JC, Barras JP Calcium dobesilate: pharmacological profile related to its use in diabetic retinopathy. Int J Clin Pract. 1999 Dec;53(8):631-6.
Brunet J, Farine JC, Garay RP, Hannaert P Angioprotective action of calcium dobesilate against reactive oxygen species-induced capillary permeability in the rat. Eur J Pharmacol. 1998 Oct 9;358(3):213-20.
Larsen HW, Sander E, Hoppe R The value of calcium dobesilate in the treatment of diabetic retinopathy. A controlled clinical trial. Diabetologia. 1977 Apr;13(2):105-9.
Lozovskaia EL, Kaplunskii GD, Sapezhinskii II [Superoxide dismutase activity and photosensitizing properties of 2,5-dihydroxybenzolsulfonate]. Biofizika. 1990 Nov-Dec;35(6):912-6. Russian.
Ruiz E, Lorente R, Tejerina T Effects of calcium dobesilate on the synthesis of endothelium-dependent relaxing factors in rabbit isolated aorta. Br J Pharmacol. 1997 Jun;121(4):711-6.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
