Bevacizumab Versus Ranibizumab for Diabetic Retinopathy
Raktažodžiai
Santrauka
Datos
Paskutinį kartą patikrinta: | 03/31/2015 |
Pirmasis pateikimas: | 10/15/2007 |
Numatytas registravimas pateiktas: | 10/15/2007 |
Pirmas paskelbtas: | 10/16/2007 |
Paskutinis atnaujinimas pateiktas: | 04/13/2015 |
Paskutinis atnaujinimas paskelbtas: | 04/14/2015 |
Faktinė studijų pradžios data: | 05/31/2008 |
Numatoma pirminio užbaigimo data: | 02/28/2013 |
Numatoma studijų užbaigimo data: | 03/31/2013 |
Būklė ar liga
Intervencija / gydymas
Drug: A
Drug: B
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Experimental: A Bevacizumab treatment | Drug: A intravitreal application |
Active Comparator: B Ranibizumab treatment | Drug: B intravitreal application |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 18 Years Į 18 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - Age ≥18 years - Patients with type 1 or type 2 diabetes mellitus - HbA1C between 6% and 9 %. - Patients with persistent diabetic macular edema with center involvement following completed grid lasercoagulation in the study eye - Patients with persistent active neovascularisations following completed panretinal lasercoagulation (at least 2000 spots) in the study eye - Last perifoveolar laser treatment 3 months before study entry - Central macular thickness (macular edema) of at least 300 - 550 microns in the central subfield as measured by OCT - Not eligible for any currently approved treatments or experimental protocols - Best corrected visual acuity, using ETDRS charts, of 20/25 to 20/200 (Snellen equivalent) in the study eye - Patients with decrease in vision in the study eye due to foveal thickening from diabetic macular edema and not to other causes, in the opinion of the investigator Exclusion Criteria: - A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure - History of systemic corticosteroids within 3 months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 3 times per week - Panretinal laser photocoagulation within the past 3 months or macular laser photocoagulation within the past 3 months in the study eye - Previous treatment with intravitreal or sub-Tenon triamcinolone within the past 3 months in the study eye - Previous participation in clinical trial involving anti-angiogenic drugs (pegabtanib sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) - History of submacular surgery or other surgical intervention for diabetic macular edema except grid lasercoagulation in the study eye - Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) |
Rezultatas
Pirminės rezultatų priemonės
1. To investigate the change in macular edema and the absolute change in visual acuity. To investigate the change of neovascularisation. [12 Months]