A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD
The Effect of Genotype and Environmental Risk Factors on Treatment Response to Intravitreal Lucentis (Ranibizumab) for Neovascular AMD
調査の概要
詳細な説明
Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. The advanced stages of the disease are characterized by the development of geographic atrophy or choroidal neovascularization, both of which result in significant loss of vision. Development of intravitreal anti-VEGF agents such as ranibizumab has significantly improved outcomes for the neovascular for of the disease. However, it is not possible to predict which individuals will respond to the treatment.
The objective of this study is to establish the association between genetic factors and treatment response to intravitreal Lucentis. This will be accomplished by SNP-genotyping participants for AMD-susceptibility and candidate angiogenesis-pathway genes, collecting environmental risk factor variables and evaluating clinical outcomes. The aim of this pharmacogenetics study will be to identify patients at the outset of their treatment that require more intensive therapy.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Oregon
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Portland、Oregon、アメリカ、97239
- Casey Eye Institute, Oregon Health and Science University
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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:
- All AMD-related CNV lesion types will be included.
- Age >50 years
- The study eye must never have received treatment for neovascular AMD
- Visual acuity in treatment eye must be between 20/30 and 20/320 (ETDRS).
Exclusion Criteria:
- Age <50 years;
- Previous therapy in either eye for AMD or other retinal disease which may be used in the treatment of AMD;
- Choroidal neovascularization not from AMD;
- Concomitant non-AMD related maculopathy in study eye;
- Active treatment for neovascular AMD in fellow eye;
- Acuity loss or central field loss from non-AMD cause;
- Pigment epithelial detachment without evidence of CNV;
- Individuals in whom Lucentis is contraindicated;
- Participation in another clinical trial in last three months
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
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：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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 |
時間枠 |
|---|---|
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The primary outcome measure is clinical treatment response to intravitreal Lucentis, defined as: 'Clinical stabilization' : stabilization of visual acuity. 'Clinical improvement'; 'Clinical progression'
時間枠：12 months
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12 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Establish the association between environmental risk factors and treatment response to intravitreal Lucentis when controlling for genotype
時間枠：12 months
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12 months
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Association between central macular thickness as measured by ocular coherence tomography (OCT) in response to Lucentis treatment and genotype/environmental risk exposure.
時間枠：12 months
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12 months
|
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Median number of intravitreal ranibizumab (Lucentis) injections required per patient
時間枠：12 months
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12 months
|
協力者と研究者
捜査官
- 主任研究者：Peter J Francis, MD PhD、Casey Eye Institute, Oregon Health and Science University
出版物と役立つリンク
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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