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)
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ClinicalTrials.gov Identifier: NCT01171976 |
Recruitment Status
:
Completed
First Posted
: July 29, 2010
Results First Posted
: September 15, 2014
Last Update Posted
: September 15, 2014
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Tracking Information | ||||
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First Submitted Date ICMJE | July 27, 2010 | |||
First Posted Date ICMJE | July 29, 2010 | |||
Results First Submitted Date | March 31, 2014 | |||
Results First Posted Date | September 15, 2014 | |||
Last Update Posted Date | September 15, 2014 | |||
Study Start Date ICMJE | September 2010 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12 [ Time Frame: Baseline to Month 12 ] 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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Original Primary Outcome Measures ICMJE |
Mean change from baseline in Best Corrected Visual Acuity (BCVA) over a 12 month treatment period. [ Time Frame: 12 months ] | |||
Change History | Complete list of historical versions of study NCT01171976 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | 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 | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Diabetic Macular Edema | |||
Intervention ICMJE | Drug: Ranibizumab
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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Study Arms |
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Publications * | Prünte C, Fajnkuchen F, Mahmood S, Ricci F, Hatz K, Studnička J, Bezlyak V, Parikh S, Stubbings WJ, Wenzel A, Figueira J; RETAIN Study Group. Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study. Br J Ophthalmol. 2016 Jun;100(6):787-95. doi: 10.1136/bjophthalmol-2015-307249. Epub 2015 Oct 9. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
373 | |||
Original Estimated Enrollment ICMJE |
345 | |||
Actual Study Completion Date | April 2013 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Patient
Ocular
Exclusion Criteria: Patient Compliance/ Administrative
Ocular medical history
Prior Ocular treatments
Systemic conditions or treatments
Other protocol-defined inclusion/exclusion criteria may apply |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Czech Republic, France, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01171976 | |||
Other Study ID Numbers ICMJE | CRFB002D2304 2010-019795-74 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Novartis ( Novartis Pharmaceuticals ) | |||
Study Sponsor ICMJE | Novartis Pharmaceuticals | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | September 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |