Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye (TWEYES)
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|ClinicalTrials.gov Identifier: NCT01986907|
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Wet Age Related Macular Degeneration||Drug: ranibizumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1049 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 12 Months, Prospective, Multicenter, Open-label, Single Arm Interventional Study Assessing the Safety and Tolerability of 0.5 mg Ranibizumab in Mono/Bilateral Wet AMD Patients in Eyes With (Best-Corrected Distance Visual Acuity) BCVA Below 2/10 and/or Second Affected Eye|
|Actual Study Start Date :||March 4, 2014|
|Actual Primary Completion Date :||June 15, 2016|
|Actual Study Completion Date :||June 15, 2016|
Administered as an Intravitreal injection
All patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e. stable VA for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections).
- Number of Participants With Systemic Drug-related Adverse Events [ Time Frame: Baseline to Month 12 ]Monitoring and recording all adverse events, including serious adverse events.
- Number of Eyes With Ocular Drug-related Adverse Events [ Time Frame: Baseline to Month 12 ]Monitoring and recording all adverse events, including serious adverse events.
- Overall Number of Ranibizumab Injections [ Time Frame: Baseline to month 12 ]
- Time Interval Between Injections in Bilateral Disease [ Time Frame: Baseline to month 12 ]Mean number of days between two consecutive injections per eye
- Mean Number of Injections Per Patient [ Time Frame: Baseline to month 12 ]Number of injections per patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986907
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|