Comparison of Therapeutic Effects Between Intravitreal Injection of Bevacizumab With Intravitreal Injection of Bevacizumab and Targeted Laser Photocoagulation of Non Perfused Areas of Retina in Patients With Acute Retinal Vein Occlusion (bevacizumab)
Patients with new onset retinal vein occlusion in less than 3 month whom has visual acuity less than 20/40 and central macular thickness more than 250micrometer and non perfused areas of retina more than 10 DD are included in over study and devided into 2 groups randomizely, Group A under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeated and follow up in this manner is continued until 9 months.
Group B is as the same of group A but patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging .
After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared,
調査の概要
状態
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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Tehran、イラン・イスラム共和国
- 募集
- Ophthalmic Research Center
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コンタクト：
- alireaza ramezani, MD
- 電話番号：009822591616
- メール：labbafi@hotmail.com
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参加基準
適格基準
就学可能な年齢
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:
- Center-involved macular edema secondary to RVO on clinical exam
- Symptoms less than 3 months
- BCVA= 20/40 or worse
- Mean center point thickness >250 μm
- Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
One eye per participant is enrolled in the trial
Exclusion Criteria:
- Macular edema due to a cause other than CRVO
- An ocular condition such that visual acuity would not improve from resolution of the edema (eg, foveal atrophy)
- Substantial cataract estimated to have reduced visual acuity by >3 lines
- Prior treatment with intravitreal or peribulbar steroid injection
- History of macular photocoagulation or PRP
- Prior pars plana vitrectomy
- Hx of Intraocular surgery (including cataract extraction)
- uveitis, NVG, exudative AMD, diabetic retinopathy, any malignancy, optic neuropathy, amblyopia
- vitreomacular traction or epiretinal membrane *uncontrolled glaucoma ( > 30mmHg with anti-glaucoma medications)
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：intravitreal injection of bevacizumab
|
under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeatet and follow up in this manner is continued until 9 months.
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アクティブコンパレータ：intravitreal injection of bevacizumab+ targeted laser
Intervention intravitreal bevacizumab injection + targeted laser photocoagulation of retinal non perfused areas
|
patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging . After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared |
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 |
|---|---|---|
|
Visual acuity
時間枠：Every month
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Snellen chart
|
Every 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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macular thickness
時間枠：every month
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OCT
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every month
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。