Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)
Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)
調査の概要
詳細な説明
We will conduct an open label, multi-center study of naïve AMD patients that are identified early upon disease progression (had a normal VA, FA or OCT within 4 months prior to entry) to assess if treating with ranibizumab monthly can restore all patients to their baseline vision pre-AMD. Recent randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with ranibizumab in patients with subfoveal CNV from AMD leads to stabilization of vision in over 90% of patients and improvement in vision in at least a third of the patients and has led to the approval of ranibizumab (0.5 mg) for the treatment of neovascular AMD.
Patients will receive monthly intravitreal ranibizumab injections for 12 months (with dose holding for return to baseline/ 20/20 or better and no evidence of fluid on SD-OCT or FA). All patients will have ETDRS vision and SD-OCT, and complete exam at each monthly visit. Patients will each have a blood analysis for genetics (either during the GALLEY study in which they converted to wet AMD and entered COMPASS or during this study).
研究の種類
入学 (実際)
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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California
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Bakersfield、California、アメリカ、93309
- California Retina Consultants
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La Jolla、California、アメリカ、92093
- Shiley Eye Center, UCSD
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Santa Barbara、California、アメリカ、93103
- California Retina Consultants
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Texas
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San Antonio、Texas、アメリカ、78240
- Medical Center Ophthalmology Associates
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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:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Naïve wet-AMD within 4 months of disease onset (for GALLEY patients) and within 3 months of disease onset for all others
- Patients that have lost > 5 letters from baseline best vision
- BCVA 20/25-20/320
Exclusion Criteria:
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial which includes an intervention (Patients could be participating in a non-interventional study such as the GALLEY study)
- Juxtafoveal and extrafoveal wet-AMD
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：なし
- 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）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Ranibizumab 0.5 mg
Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year
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0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
他の名前：
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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 |
|---|---|---|
|
Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months
時間枠：Baseline, Month 6 and Month 12
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PI is no longer affiliated with institution.
All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site.
Data from these participants is being reported here.
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Baseline, Month 6 and Month 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months.
時間枠：Baseline, Month 6 and Month 12
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Mean change was measured by letters gained or lost.
A positive number is letters gained, and a negative number is letters lost.
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Baseline, Month 6 and Month 12
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Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months
時間枠：Baseline, Month 6 and Month 12
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Baseline, Month 6 and Month 12
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協力者と研究者
協力者
捜査官
- スタディチェア：Henry Ferreyra, MD、University of California, San Diego
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 (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。