Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy
Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy
調査の概要
状態
詳細な説明
Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the efficacy of reducing neovascularization activity before vitrectomy by preoperative intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is used as an adjunct therapy, a shortterm effect is needed. Because it is reported some adverse events caused by bevacizumab injection. Hattori et al reported intravitreal injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and August 2013 at Surugadai Hospital of Nihon University. The risks to participants are accompanied by the intravitreal injection of bevacizumab (especially the possibility of endophthalmitis and thromboembolic events).
Between June 2012 and August 2013, one investigator (AM) randomized PDR patients with an indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected at the start of surgery, and intraoperative and postoperative complications were evaluated.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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-
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Tokyo、日本、101-8309
- Surugadai Nihon university hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
- Indicated for vitrectomy
Exclusion Criteria:
- History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Bevacizumab injection and vitrectomy
0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
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0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
他の名前：
vitrectomy of 25 gauge system.
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偽コンパレータ：Sham injection and vitrectomy
Sham injection one day before vitrectomy.
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vitrectomy of 25 gauge system.
Sham injection one day before vitrectomy
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Reoperation
時間枠：1 month
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Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
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1 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intra Operative Hemorrhage
時間枠：End of the surgery.
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Calculate the number of coagulators for the intra operative hemorrhage.
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End of the surgery.
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Postoperative Vitreous Hemorrhage.
時間枠：1 month
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Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
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1 month
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Vascular Endothelial Growth Factor Concentration in Vitreous
時間枠：Start of surgery.
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Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
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Start of surgery.
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Endolaser Photocoagulation
時間枠：End of surgery.
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Number of intraoperative endolaser photocoagulation.
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End of surgery.
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Iatrogenic Retinal Tears
時間枠：End of surgery.
|
The number of participants who had intraoperative iatrogenic retinal tears.
|
End of surgery.
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Surgical Time
時間枠：End of surgery.
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End of surgery.
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Postoperative Best Corrected Visual Acuity
時間枠：1 mouth after surgery.
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Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis. The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome. |
1 mouth after surgery.
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Best Corrected Visual Acuity Change
時間枠：1 month
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Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity. The higher values represent a worse outcome. |
1 month
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Postoperative Neovascular Glaucoma
時間枠：Within 1 month after the surgery.
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The number of participants with progressive or persistent neovascular glaucoma after surgery.
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Within 1 month after the surgery.
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Elevated Intraocular Pressure
時間枠：Within 1 month after the surgery.
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The number of participants with elevated intraocular pressure after surgery.
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Within 1 month after the surgery.
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Gas Tamponade
時間枠：End of surgery.
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The number of participants with gas tamponade at the end of the surgery.
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End of surgery.
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Silicon Oil Tamponade
時間枠：End of surgery.
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The number of participants with silicon oil tamponade at the end of the surgery.
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End of surgery.
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Ayumu Manabe
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Bevacizumabの臨床試験
-
Weill Medical College of Cornell University終了しました多形性膠芽腫 | 退形成性星細胞腫 | びまん性内因性橋グリオーマ | 脳幹グリオーマ | 毛包粘液性星細胞腫 | 脳幹の神経膠腫 | 脳の線維性星細胞腫 | 混合乏突起膠腫-星細胞腫アメリカ