The proposed indication for this drug is to slow DR progression. The disease process involved is the effect of diabetes in causing a complication of DR, which becomes progressively worse. The claim is not to cure DR, but to slow the rate of progression, which is measured by changes in Early Treatment Diabetic Retinopathy Study (ETDRS) steps as outlined in the TGA guidelines. Scope of the clinical dossier The submission contained the following clinical information: Tabular listing of all clinical studies Clinical study reports Reports of efficacy and safety studies [for the indication ‘dyslipidaemia’] Study reports of controlled clinical studies pertinent to the claimed indication Literature references Paediatric data No new information available. Good clinical practice No new information available. 1: Tabular Listing of All Clinical Studies Type Trial Test Study of of of the Design of of of Status; Study Study and Dosage Type Report Type of Regimen; of Control Route of Phase Trial Evaluate 1012 T2DM 5 III the 200 mg, (Full benefit of once daily, Full five oral set) of treatment with on the in a of of the or FIELD Study on of DR
The proposed indication for this drug is to slow DR progression. The disease process involved is the effect of diabetes in causing a complication of DR, which becomes progressively worse. The claim is not to cure DR, but to slow the rate of progression, which is measured by changes in Early Treatment Diabetic Retinopathy Study (ETDRS) steps as outlined in the TGA guidelines. Scope of the clinical dossier The submission contained the following clinical information: Tabular listing of all clinical studies Clinical study reports Reports of efficacy and safety studies [for the indication ‘dyslipidaemia’] Study reports of controlled clinical studies pertinent to the claimed indication Literature references Paediatric data No new information available. Good clinical practice No new information available. 1: Tabular Listing of All Clinical Studies Type of Study of Report of the Study Design and Type of Control Test Dosage Regimen; Route of of of of Study Status; Type of Phase III Evaluate the benefit of five of treatment with on the of or of DR in a of the FIELD Study 200 mg, once daily, oral 1012 (Full set) T2DM 5 Full on Trial Trial