Bevacizumab Versus Ranibizumab for Diabetic Retinopathy
キーワード
概要
日付
最終確認済み: | 03/31/2015 |
最初に提出された: | 10/15/2007 |
提出された推定登録数: | 10/15/2007 |
最初の投稿: | 10/16/2007 |
最終更新が送信されました: | 04/13/2015 |
最終更新日: | 04/14/2015 |
実際の研究開始日: | 05/31/2008 |
一次完了予定日: | 02/28/2013 |
研究完了予定日: | 03/31/2013 |
状態または病気
介入/治療
Drug: A
Drug: B
段階
アームグループ
腕 | 介入/治療 |
---|---|
Experimental: A Bevacizumab treatment | Drug: A intravitreal application |
Active Comparator: B Ranibizumab treatment | Drug: B intravitreal application |
適格基準
研究の対象となる年齢 | 18 Years に 18 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | 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) |
結果
主な結果の測定
1. To investigate the change in macular edema and the absolute change in visual acuity. To investigate the change of neovascularisation. [12 Months]