Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus (RETAIN)
2014年9月10日 更新者：Novartis Pharmaceuticals
A 2 Year Randomized, Single-masked, Multicenter, Controlled Phase IIIb Trial Assessing the Efficacy and Safety of 0.5 mg Ranibizumab in Two "Treat and Extend" Treatment Algorithms vs. 0.5 mg Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.
調査の概要
研究の種類
介入
入学 (実際)
373
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Dublin、アイルランド
- Novartis Investigative Site
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Dublin 7、アイルランド
- Novartis Investigative Site
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Kilkenny、アイルランド
- Novartis Investigative Site
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Limerick、アイルランド
- Novartis Investigative Site
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Aberdeen、イギリス、AB25 2ZN
- Novartis Investigative Site
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Bristol、イギリス、BS1 2LX
- Novartis Investigative Site
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Leeds、イギリス、LS9 7TF
- Novartis Investigative Site
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Manchester、イギリス、M13 9WL
- Novartis Investigative Site
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Newcastle Upon Tyne、イギリス、NE1 4LP
- Novartis Investigative Site
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Sheffield、イギリス、S10 2JF
- Novartis Investigative Site
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Southampton、イギリス、SO16 6YD
- Novartis Investigative Site
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Sunderland、イギリス、SR2 9HP
- Novartis Investigative Site
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Wolverhampton、イギリス、WV10 0QP
- Novartis Investigative Site
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Surrey
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Frimley、Surrey、イギリス、GU16 7UJ
- Novartis Investigative Site
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FI
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Firenze、FI、イタリア、50134
- Novartis Investigative Site
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MI
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Milano、MI、イタリア、20132
- Novartis Investigative Site
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Milano、MI、イタリア、20122
- Novartis Investigative Site
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Milano、MI、イタリア、20157
- Novartis Investigative Site
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RM
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Roma、RM、イタリア、00133
- Novartis Investigative Site
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Roma、RM、イタリア、00198
- Novartis Investigative Site
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Amsterdam、オランダ、1081 HV
- Novartis Investigative Site
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Amsterdam、オランダ、1105 AZ
- Novartis Investigative Site
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Leiden 2333 ZA、オランダ、2333
- Novartis Investigative Site
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Nijmegen、オランダ、6525 EX
- Novartis Investigative Site
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Rotterdam、オランダ、3011 BH
- Novartis Investigative Site
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Athens、ギリシャ、152 31
- Novartis Investigative Site
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Thessaloniki、ギリシャ、546 36
- Novartis Investigative Site
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Crete
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Heraklion Crete、Crete、ギリシャ、GR-71110
- Novartis Investigative Site
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Bern、スイス、3010
- Novartis Investigative Site
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Bern、スイス、3012
- Novartis Investigative Site
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Binningen、スイス、4102
- Novartis Investigative Site
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Zürich、スイス、8063
- Novartis Investigative Site
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Las Palmas de Gran Canaria、スペイン、35016
- Novartis Investigative Site
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Madrid、スペイン、28040
- Novartis Investigative Site
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Andalucia
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Málaga、Andalucia、スペイン、29010
- Novartis Investigative Site
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Castilla y Leon
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Valladolid、Castilla y Leon、スペイン、47011
- Novartis Investigative Site
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Cataluña
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L'Hospitalet de Llobregat、Cataluña、スペイン、08907
- Novartis Investigative Site
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Comunidad Valenciana
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Alicante、Comunidad Valenciana、スペイン、03016
- Novartis Investigative Site
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Valencia、Comunidad Valenciana、スペイン、46015
- Novartis Investigative Site
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Galicia
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Santiago de Compostela、Galicia、スペイン、15705
- Novartis Investigative Site
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Hradec Kralove、チェコ共和国、505 05
- Novartis Investigative Site
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Olomouc、チェコ共和国、775 20
- Novartis Investigative Site
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Plzen、チェコ共和国、301 00
- Novartis Investigative Site
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Prague 2、チェコ共和国、128 08
- Novartis Investigative Site
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Praha 6、チェコ共和国、169 02
- Novartis Investigative Site
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Budapest、ハンガリー、1083
- Novartis Investigative Site
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Budapest、ハンガリー、1133
- Novartis Investigative Site
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Debrecen、ハンガリー、4012
- Novartis Investigative Site
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Gyor、ハンガリー、9024
- Novartis Investigative Site
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Bordeaux、フランス、33 000
- Novartis Investigative Site
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Dijon、フランス、21034
- Novartis Investigative Site
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Lille、フランス、59 037
- Novartis Investigative Site
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Limoges Cedex、フランス、87042
- Novartis Investigative Site
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Lyon、フランス、69003
- Novartis Investigative Site
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Nantes Cedex 1、フランス、44093
- Novartis Investigative Site
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Nice、フランス、6 000
- Novartis Investigative Site
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Paris、フランス、75015
- Novartis Investigative Site
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Paris cedex 10、フランス、75475
- Novartis Investigative Site
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Gent、ベルギー、9000
- Novartis Investigative Site
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Kortrijk、ベルギー、8500
- Novartis Investigative Site
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Leuven、ベルギー、3000
- Novartis Investigative Site
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Coimbra、ポルトガル、3000-354
- Novartis Investigative Site
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Lisboa、ポルトガル、1150-199
- Novartis Investigative Site
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Porto、ポルトガル、4099-001
- Novartis Investigative Site
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Bielsko-Biala、ポーランド、43-300
- Novartis Investigative Site
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Lublin、ポーランド、20-954
- Novartis Investigative Site
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Warszawa、ポーランド、00-416
- Novartis Investigative Site
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Wroclaw、ポーランド、50-367
- Novartis Investigative Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
Patient
- Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization [WHO] guidelines) with glycosylated hemoglobin (HbA1c) ≤ 12.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes. Treatment for diabetes must have been stable for at least 3 month.
Ocular
- Patients with visual impairment due to DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected by the investigator as the study eye.
- BCVA ≥ 39 and ≤78 letters in the study eye and, inclusively, using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) at screening.
- Concomitant conditions in the study eye are only permitted if, in the opinion of the investigator, they do not prevent improvement of visual acuity on study treatment.
Exclusion Criteria:
Patient Compliance/ Administrative
- Pregnant or nursing (lactating) women.
Ocular medical history
- Active intraocular inflammation (grade trace or above) in either eye at enrollment.
- Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye at the time of enrollment.
- History of uveitis in either eye at any time.
- Structural damage within 0.5 disc diameter of the center of the macular in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema.
- Uncontrolled glaucoma in either eye at screening.
Prior Ocular treatments
- Panretinal laser photocoagulation in the study eye within 6 months prior to randomization.
- Focal/grid laser photocoagulation in the study eye within 3 months prior to randomization.
- Treatment with anti-angiogenic drugs in either eye.
Systemic conditions or treatments
- History of stroke within 6 months prior to enrollment.
- Renal failure requiring dialysis.
- Untreated diabetes mellitus.
- Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg.
Other protocol-defined inclusion/exclusion criteria may apply
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
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実験的：TE Ranibizumab 0.5 mg and Laser
On Day 1, all patients received an intravitreal injection with 0.5 mg ranibizumab and subsequently entered Phase A which comprised of monthly injections.
Laser therapy was applied at Day 1.
It could then be re-administered according to ETDRS criteria at any visit with 0.5 mg ranibizumab treatment if deemed necessary by the Treating Investigator with a minimal treatment interval between laser treatments of 3 months.
Laser therapy was administered ≥ 30 minutes prior to the ranibizumab injection.
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Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05
mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.
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実験的：TE Ranibizumab 0.5 mg alone
Patients received ranibizumab intravitreal injection therapy only.
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Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05
mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.
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アクティブコンパレータ：PRN Ranibizumab 0.5 mg
Patients received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
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Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05
mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.
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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 |
|---|---|---|
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Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
時間枠：Baseline to Month 12
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Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction.
The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
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Baseline to 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 |
|---|---|---|
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Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24
時間枠：Baseline to Month 24
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Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction.
The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
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Baseline to Month 24
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Visual Acuity of the Study Eye: Change From Baseline at Month 12
時間枠：Baseline and Month 12
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Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction.
The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
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Baseline and Month 12
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Visual Acuity of the Study Eye: Change From Baseline at Month 24
時間枠：Baseline and Month 24
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Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction.
The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
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Baseline and Month 24
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Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
時間枠：Baseline, Month 12
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Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction.
The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
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Baseline, Month 12
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Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
時間枠：Baseline, 24 month
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Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction.
The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
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Baseline, 24 month
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Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12
時間枠：Baseline, Month 12
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High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc.
These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration.
CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
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Baseline, Month 12
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Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24
時間枠：Baseline and 24 month
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High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc.
These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration.
CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
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Baseline and 24 month
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Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24
時間枠：Baseline, Month 12 and Month 24
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The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and symptoms on general health.
The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision.
For each, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome.
Each response was recoded per the scoring rules outlined in the National Eye Institute (NEI) VFQ-25 Scoring Algorithm.
Under this scoring algorithm , the recoded values range between 0 and 100 and a high score means a better functioning
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Baseline, Month 12 and Month 24
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EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24
時間枠：Baseline, Month 12 and Month 24
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The Euro Quality of Life Questionnaire (EQ-5D) is an indirect utility questionnaire.
It is a standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The possible range for each dimension was 1 to 3, where 1= "no problems", 2="some problems" and 3="extreme problems" .
A composite health index was then defined by combining the levels for each dimension.
Overall, 243 health states are possible.
For each health state, the EuroQol group has assigned a utility value typically between 0 and 1 with lower scores representing a higher level of dysfunction
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Baseline, Month 12 and Month 24
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年9月1日
一次修了 (実際)
2013年4月1日
研究の完了 (実際)
2013年4月1日
試験登録日
最初に提出
2010年7月27日
QC基準を満たした最初の提出物
2010年7月27日
最初の投稿 (見積もり)
2010年7月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年9月15日
QC基準を満たした最後の更新が送信されました
2014年9月10日
最終確認日
2014年9月1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。