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)
2014년 9월 10일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
373
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Athens, 그리스, 152 31
- Novartis Investigative Site
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Thessaloniki, 그리스, 546 36
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Crete
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Heraklion Crete, Crete, 그리스, GR-71110
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Amsterdam, 네덜란드, 1081 HV
- Novartis Investigative Site
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Amsterdam, 네덜란드, 1105 AZ
- Novartis Investigative Site
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Leiden 2333 ZA, 네덜란드, 2333
- Novartis Investigative Site
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Nijmegen, 네덜란드, 6525 EX
- Novartis Investigative Site
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Rotterdam, 네덜란드, 3011 BH
- Novartis Investigative Site
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Gent, 벨기에, 9000
- Novartis Investigative Site
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Kortrijk, 벨기에, 8500
- Novartis Investigative Site
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Leuven, 벨기에, 3000
- Novartis Investigative Site
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Bern, 스위스, 3010
- Novartis Investigative Site
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Bern, 스위스, 3012
- Novartis Investigative Site
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Binningen, 스위스, 4102
- Novartis Investigative Site
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Zürich, 스위스, 8063
- Novartis Investigative Site
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Las Palmas de Gran Canaria, 스페인, 35016
- Novartis Investigative Site
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Madrid, 스페인, 28040
- Novartis Investigative Site
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Andalucia
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Málaga, Andalucia, 스페인, 29010
- Novartis Investigative Site
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Castilla y Leon
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Valladolid, Castilla y Leon, 스페인, 47011
- Novartis Investigative Site
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Cataluña
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L'Hospitalet de Llobregat, Cataluña, 스페인, 08907
- Novartis Investigative Site
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Comunidad Valenciana
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Alicante, Comunidad Valenciana, 스페인, 03016
- Novartis Investigative Site
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Valencia, Comunidad Valenciana, 스페인, 46015
- Novartis Investigative Site
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Galicia
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Santiago de Compostela, Galicia, 스페인, 15705
- Novartis Investigative Site
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Dublin, 아일랜드
- Novartis Investigative Site
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Dublin 7, 아일랜드
- Novartis Investigative Site
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Kilkenny, 아일랜드
- Novartis Investigative Site
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Limerick, 아일랜드
- Novartis Investigative Site
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Aberdeen, 영국, AB25 2ZN
- Novartis Investigative Site
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Bristol, 영국, BS1 2LX
- Novartis Investigative Site
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Leeds, 영국, LS9 7TF
- Novartis Investigative Site
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Manchester, 영국, M13 9WL
- Novartis Investigative Site
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Newcastle Upon Tyne, 영국, NE1 4LP
- Novartis Investigative Site
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Sheffield, 영국, S10 2JF
- Novartis Investigative Site
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Southampton, 영국, SO16 6YD
- Novartis Investigative Site
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Sunderland, 영국, SR2 9HP
- Novartis Investigative Site
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Wolverhampton, 영국, WV10 0QP
- Novartis Investigative Site
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Surrey
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Frimley, Surrey, 영국, GU16 7UJ
- Novartis Investigative Site
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FI
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Firenze, FI, 이탈리아, 50134
- Novartis Investigative Site
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MI
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Milano, MI, 이탈리아, 20132
- Novartis Investigative Site
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Milano, MI, 이탈리아, 20122
- Novartis Investigative Site
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Milano, MI, 이탈리아, 20157
- Novartis Investigative Site
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RM
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Roma, RM, 이탈리아, 00133
- Novartis Investigative Site
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Roma, RM, 이탈리아, 00198
- Novartis Investigative Site
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Hradec Kralove, 체코 공화국, 505 05
- Novartis Investigative Site
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Olomouc, 체코 공화국, 775 20
- Novartis Investigative Site
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Plzen, 체코 공화국, 301 00
- Novartis Investigative Site
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Prague 2, 체코 공화국, 128 08
- Novartis Investigative Site
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Praha 6, 체코 공화국, 169 02
- Novartis Investigative Site
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Coimbra, 포르투갈, 3000-354
- Novartis Investigative Site
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Lisboa, 포르투갈, 1150-199
- Novartis Investigative Site
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Porto, 포르투갈, 4099-001
- Novartis Investigative Site
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Bielsko-Biala, 폴란드, 43-300
- Novartis Investigative Site
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Lublin, 폴란드, 20-954
- Novartis Investigative Site
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Warszawa, 폴란드, 00-416
- Novartis Investigative Site
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Wroclaw, 폴란드, 50-367
- Novartis Investigative Site
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Bordeaux, 프랑스, 33 000
- Novartis Investigative Site
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Dijon, 프랑스, 21034
- Novartis Investigative Site
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Lille, 프랑스, 59 037
- Novartis Investigative Site
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Limoges Cedex, 프랑스, 87042
- Novartis Investigative Site
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Lyon, 프랑스, 69003
- Novartis Investigative Site
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Nantes Cedex 1, 프랑스, 44093
- Novartis Investigative Site
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Nice, 프랑스, 6 000
- Novartis Investigative Site
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Paris, 프랑스, 75015
- Novartis Investigative Site
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Paris cedex 10, 프랑스, 75475
- Novartis Investigative Site
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Budapest, 헝가리, 1083
- Novartis Investigative Site
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Budapest, 헝가리, 1133
- Novartis Investigative Site
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Debrecen, 헝가리, 4012
- Novartis Investigative Site
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Gyor, 헝가리, 9024
- Novartis Investigative Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 9월 1일
기본 완료 (실제)
2013년 4월 1일
연구 완료 (실제)
2013년 4월 1일
연구 등록 날짜
최초 제출
2010년 7월 27일
QC 기준을 충족하는 최초 제출
2010년 7월 27일
처음 게시됨 (추정)
2010년 7월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 9월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 9월 10일
마지막으로 확인됨
2014년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .