Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal Vasculopathy (RANTA)
Multicenter Randomized Controlled Study of Intravitreal Ranibizumab and Triamcinolone Acetonide Combination Therapy Versus Ranibizumab Monotherapy in Patients With Polypoidal Choroidal Vasculopathy
調査の概要
詳細な説明
Polypoidal choroidal vasculopathy (PCV), a vascular disease of the choroid, appears to be the predominant subtype of exudative or "wet" AMD in Asian populations, in contrast to choroidal neovascularization secondary to AMD (CNV-AMD) in Western populations. There are distinct differences in pathophysiological, clinical and epidemiological factors between the two subtypes, although they also share some common risk factors. In contrast to CNV-AMD, PCV does not seem to respond as well to anti-VEGF treatment. The optimal treatment option for PCV remains elusive, with most studies showing good short-term visual outcome but poorer longer-term outcome with current treatment strategies. Therefore, understanding the pathogenesis of PCV, while developing novel and effective treatments strategies to prevent PCV-related vision loss is significant unmet needs.
The purpose of this study is to assess the effects and safety of ranibizumab therapy combined with TA versus ranibizumab monotherapy in patients with PCV. Second, the pharmacogenetics effect of inflammatory related genes and polymorphism in response to the treatments of PCV will be explored. To further confirm the role of inflammatory factors in the pathogenesis and advance of PCV, it is important to determine the levels of inflammatory factors in the anterior chamber aqueous humor from PCV patients, comparing with the aqueous humor acquired from the age-matched age-related cataract patients undergoing phacoemulsification.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Beijing
-
Beijing、Beijing、中国
- Beijing Aier Intech Eye Hospital
-
-
Guangdong
-
Guanzhou、Guangdong、中国
- Guangzhou Aier Eye Hospital
-
Shenzhen、Guangdong、中国、510000
- Shenzhen Aier Eye Hospital
-
Shenzhen、Guangdong、中国、528000
- Shenzhen Eye Hospital
-
-
Heilongjiang
-
Harbin、Heilongjiang、中国
- Harbin Aier Eye Hospital
-
-
Hubei
-
Wuhan、Hubei、中国
- Wuhan General Hospital of Pla
-
-
Zhejiang
-
Wenzhou、Zhejiang、中国、325027
- The Eye Hospital of Wenzhou Medical University
-
-
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:
- bestcorrected visual acuity (BCVA) letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts at a starting distance of 4 m (20/40 to 20/320 Snellen equivalent);
- a greatest lineardimensionof the lesion of <5400 um( 9 Macular Photocoagulation Study disk areas), assessed by ICGA;
- Cross-reading by different center to confirmed diagnosis of PCV, that is, presence of early subretinal focal ICGA hyperfluorescence (appearing within the first 6 minutes after injection of indocyanine green) and in addition, at least one of the following angiographic or clinical criteria: (i) association with a BVN, (ii) presence of pulsatile polyp, (iii) nodular appearance when viewed stereoscopically, (iv) presence of hypofluorescent halo (in first 6 minutes),7 (v) orange subretinal nodules in stereoscopic color fundus photograph (polyp corresponding to ICGA lesions), or (vi) association with massive submacular hemorrhage (defined as size of hemorrhage of at least 4 disk areas).
Exclusion Criteria:
- received treatment previously with verteporfin PDT, focal laser photocoagulation, transpupillary thermotherapy, pneumatic displacement of subretinal blood, or any investigational treatment;
- a history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia;
- experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma;
- undergone intraocular surgery (except uncomplicated cataract extraction with intraocular lens implantation within 60 days before the screening visit)
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Ranibizumab + Triamcinolone Acetonide
intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg
|
Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.
他の名前：
Intravitreal inject 0.5mg of Ranibizumab.
他の名前：
|
|
アクティブコンパレータ：Ranibizumab
intravitreal injection: Ranibizumab 0.5mg
|
Intravitreal inject 0.5mg of Ranibizumab.
他の名前：
|
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 |
|---|---|---|
|
Change of mean BCVA
時間枠：12 months
|
Change of Central BCVA (Measured with EDTRS Chart,numbers of letters) (primary: baseline and 6 months, secondary: baseline to 12 months)
|
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change of Central Rerina Thickness
時間枠：12 months
|
Change of Central Rerina Thickness (um) (primary: between baseline and 6 months, secondary: between baseline to 12 months)
|
12 months
|
|
regression of Branch vacular network(BVN)
時間枠：12 months
|
Size of Branch vascular network (um)
|
12 months
|
|
Polyps regression
時間枠：12 months
|
Size of polyps (um)(primary: between baseline and 6 months, secondary: between baseline to 12 months)
|
12 months
|
|
Number of re-treatments
時間枠：12 month
|
re-treatments numbers
|
12 month
|
協力者と研究者
捜査官
- スタディチェア：Shibo Tang、Aier School of Ophthalmology, Central South University
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 (見積もり)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IRB2016006
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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。