Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
NCT ID: NCT01535261
Last Updated: 2016-10-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
357 participants
INTERVENTIONAL
2012-02-29
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ranibizumab arm
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
Ranibizumab 0.5 mg/0.05 ml
Patients will receive the first dose at Baseline, as an intravitreal injection with a standard dose of 0.5 mg/0.05 ml. Patients will receive at least 3 study treatments at monthly intervals (Day 1, Month 1 and Month 2). The last mandatory dose during treatment initiation will be administered approximately 60 days after the first study treatment. If there is no improvement in VA over the course of the first 3 injections, continued treatment is not recommended and the patient may receive alternative treatment at the investigator's discretion.
Interventions
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Ranibizumab 0.5 mg/0.05 ml
Patients will receive the first dose at Baseline, as an intravitreal injection with a standard dose of 0.5 mg/0.05 ml. Patients will receive at least 3 study treatments at monthly intervals (Day 1, Month 1 and Month 2). The last mandatory dose during treatment initiation will be administered approximately 60 days after the first study treatment. If there is no improvement in VA over the course of the first 3 injections, continued treatment is not recommended and the patient may receive alternative treatment at the investigator's discretion.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of visual impairment exclusively due to ME secondary to CRVO
* BCVA score at Screening and Baseline between 73 and 19 letters Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalent of 20/40 and 20/400)
Exclusion Criteria
* Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
* Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
* Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline (eg, sorafenib \[Nexavar®\], sunitinib \[Sutent®\], bevacizumab \[Avastin®\])
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Parramatta, New South Wales, Australia
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Sydney, New South Wales, Australia
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Melbourne, Victoria, Australia
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Nedlands, Western Australia, Australia
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Vienna, Austria, Austria
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Linz, , Austria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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London, Ontario, Canada
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Boisbriand, Quebec, Canada
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Montreal, Quebec, Canada
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Olomouc, , Czechia
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Prague, , Czechia
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Glostrup Municipality, , Denmark
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Pátrai, Greece, Greece
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Thessaloniki, Greece, Greece
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Athens, GR, Greece
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Heraklion Crete, GR, Greece
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Larissa, GR, Greece
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Thessaloniki, GR, Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Dublin, Ireland, Ireland
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Dublin, , Ireland
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Bologna, BO, Italy
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Florence, FI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Roma, RM, Italy
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Torino, TO, Italy
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Udine, , Italy
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Leiden 2333 ZA, Netherlands, Netherlands
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Amsterdam, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Tilburg, , Netherlands
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Bielsko-Biala, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Porto, Porto District, Portugal
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Coimbra, Portugal, Portugal
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Coimbra, Portugal, Portugal
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Porto, Portugal, Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Žilina, Slovak Republic, Slovakia
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Bratislava, Slovakia, Slovakia
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Banská Bystrica, , Slovakia
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Bilbao, Basque Country, Spain
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Valladolid, Castille and León, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Santiago de Compostela, Galicia, Spain
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Alicante, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Örebro, , Sweden
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Zurich, Switzerland, Switzerland
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Bern, , Switzerland
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Lausanne, , Switzerland
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Ankara, Turkey, Turkey (Türkiye)
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Frimley, Surrey, United Kingdom
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London, United Kingdom, United Kingdom
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Belfast, , United Kingdom
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Birmingham, , United Kingdom
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Bristol, , United Kingdom
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Hull, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Plymouth, , United Kingdom
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Southampton, , United Kingdom
Countries
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References
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Pawloff M, Bogunovic H, Gruber A, Michl M, Riedl S, Schmidt-Erfurth U. SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES. Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385.
Larsen M, Waldstein SM, Priglinger S, Hykin P, Barnes E, Gekkieva M, Das Gupta A, Wenzel A, Mones J; CRYSTAL Study Group. Sustained Benefits from Ranibizumab for Central Retinal Vein Occlusion with Macular Edema: 24-Month Results of the CRYSTAL Study. Ophthalmol Retina. 2018 Feb;2(2):134-142. doi: 10.1016/j.oret.2017.05.016. Epub 2017 Sep 9.
Other Identifiers
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2011-002350-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRFB002E2401
Identifier Type: -
Identifier Source: org_study_id