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)
10 września 2014 zaktualizowane przez: 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.
Przegląd badań
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
373
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Gent, Belgia, 9000
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Kortrijk, Belgia, 8500
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Leuven, Belgia, 3000
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Bordeaux, Francja, 33 000
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Dijon, Francja, 21034
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Lille, Francja, 59 037
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Limoges Cedex, Francja, 87042
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Lyon, Francja, 69003
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Nantes Cedex 1, Francja, 44093
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Nice, Francja, 6 000
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Paris, Francja, 75015
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Paris cedex 10, Francja, 75475
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Athens, Grecja, 152 31
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Thessaloniki, Grecja, 546 36
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Crete
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Heraklion Crete, Crete, Grecja, GR-71110
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Las Palmas de Gran Canaria, Hiszpania, 35016
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Madrid, Hiszpania, 28040
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Andalucia
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Málaga, Andalucia, Hiszpania, 29010
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Castilla y Leon
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Valladolid, Castilla y Leon, Hiszpania, 47011
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Cataluña
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L'Hospitalet de Llobregat, Cataluña, Hiszpania, 08907
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Comunidad Valenciana
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Alicante, Comunidad Valenciana, Hiszpania, 03016
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Valencia, Comunidad Valenciana, Hiszpania, 46015
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Galicia
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Santiago de Compostela, Galicia, Hiszpania, 15705
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Amsterdam, Holandia, 1081 HV
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Amsterdam, Holandia, 1105 AZ
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Leiden 2333 ZA, Holandia, 2333
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Nijmegen, Holandia, 6525 EX
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Rotterdam, Holandia, 3011 BH
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Dublin, Irlandia
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Dublin 7, Irlandia
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Kilkenny, Irlandia
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Limerick, Irlandia
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Bielsko-Biala, Polska, 43-300
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Lublin, Polska, 20-954
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Warszawa, Polska, 00-416
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Wroclaw, Polska, 50-367
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Coimbra, Portugalia, 3000-354
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Lisboa, Portugalia, 1150-199
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Porto, Portugalia, 4099-001
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Hradec Kralove, Republika Czeska, 505 05
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Olomouc, Republika Czeska, 775 20
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Plzen, Republika Czeska, 301 00
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Prague 2, Republika Czeska, 128 08
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Praha 6, Republika Czeska, 169 02
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Bern, Szwajcaria, 3010
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Bern, Szwajcaria, 3012
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Binningen, Szwajcaria, 4102
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Zürich, Szwajcaria, 8063
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Budapest, Węgry, 1083
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Budapest, Węgry, 1133
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Debrecen, Węgry, 4012
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Gyor, Węgry, 9024
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FI
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Firenze, FI, Włochy, 50134
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MI
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Milano, MI, Włochy, 20132
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Milano, MI, Włochy, 20122
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Milano, MI, Włochy, 20157
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Roma, RM, Włochy, 00133
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Roma, RM, Włochy, 00198
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Aberdeen, Zjednoczone Królestwo, AB25 2ZN
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Bristol, Zjednoczone Królestwo, BS1 2LX
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Leeds, Zjednoczone Królestwo, LS9 7TF
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Manchester, Zjednoczone Królestwo, M13 9WL
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Newcastle Upon Tyne, Zjednoczone Królestwo, NE1 4LP
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Sheffield, Zjednoczone Królestwo, S10 2JF
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Southampton, Zjednoczone Królestwo, SO16 6YD
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Sunderland, Zjednoczone Królestwo, SR2 9HP
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Wolverhampton, Zjednoczone Królestwo, WV10 0QP
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Surrey
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Frimley, Surrey, Zjednoczone Królestwo, GU16 7UJ
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline and 24 month
|
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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
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Sponsor
Publikacje i pomocne linki
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 września 2010
Zakończenie podstawowe (Rzeczywisty)
1 kwietnia 2013
Ukończenie studiów (Rzeczywisty)
1 kwietnia 2013
Daty rejestracji na studia
Pierwszy przesłany
27 lipca 2010
Pierwszy przesłany, który spełnia kryteria kontroli jakości
27 lipca 2010
Pierwszy wysłany (Oszacować)
29 lipca 2010
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
15 września 2014
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
10 września 2014
Ostatnia weryfikacja
1 września 2014
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia metabolizmu glukozy
- Choroby metaboliczne
- Choroby Układu Nerwowego
- Choroby oczu
- Objawy neurologiczne
- Choroby układu hormonalnego
- Zwyrodnienie siatkówki
- Choroby siatkówki
- Zwyrodnienie plamki żółtej
- Zaburzenia czucia
- Cukrzyca
- Obrzęk plamki żółtej
- Obrzęk
- Wizja, niski
- Zaburzenia widzenia
- Fizjologiczne skutki leków
- Środki przeciwnowotworowe
- Inhibitory angiogenezy
- Środki modulujące angiogenezę
- Substancje wzrostowe
- Inhibitory wzrostu
- Ranibizumab
Inne numery identyfikacyjne badania
- CRFB002D2304
- 2010-019795-74 (Numer EudraCT)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .