Aflibercept (EYLEA)as Secondary or Third Line Treatment for Neovascular Age-related Macular Degeneration.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01918878|
Recruitment Status : Unknown
Verified September 2015 by Hadassah Medical Organization.
Recruitment status was: Active, not recruiting
First Posted : August 8, 2013
Last Update Posted : January 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age-related Macular Degeneration||Drug: Aflibercept (EYLEA)||Phase 4|
The aim of this study is to prospectively evaluate the use of aflibercept in patients in whom initial incomplete response or loss of initial response for other intravitreal anti- vascular endothelial growth factor (anti-VEGF) therapy was demonstrated.
This is a multi-center study initiated and conducted by the Israeli retina association. Each center participating in the study will follow the same protocol including standardized measurement of visual acuity, OCT, and Fluorescein angiography (FA).
We will enroll 48 NVAMD patients which are partial or non-responded for 3-6 injections of intravitreal bevacizumab or ranibizumab and no more than one year of treatment .
Monthly intravitreal aflibercept 2mg /0.05 ml will be given at enrolment (day 0), 4 weeks, 8 weeks, 16 weeks, and 24 weeks after the initial enrollment for the study group.
Follow-up period will be 28 weeks,7 visits. At the 28 week visit the primary and secondary end points will be evaluated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 7-month, Multicenter Study to Evaluate the Efficacy of Intravitreal Injections of Aflibercept (EYLEA) 2mg /0.05 ml as Secondary or Third Line Treatment for Neovascular Age-related Macular Degeneration (NVAMD).|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
Experimental: Aflibercept (EYLEA)
Intravitreal injection of aflibercept (EYLEA) 2mg/0.05ml at enrolment (day 0), 4 weeks, 8 weeks, 16 weeks and 24 weeks. Aflibercept will be provided for total period of 24 weeks
Drug: Aflibercept (EYLEA)
INTARAVITREAL INJECTION OF AFLIBERCEPT
Other Name: EYLEA
- Central macular thickness change [ Time Frame: at week 28 ]Central macular thickness change from baseline on optical coherence tomography (OCT) at week 28.
- change in best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity and Change in CNV size [ Time Frame: at week 28 ]
- The mean change in best corrected ETDRS visual acuity at 4 meters according to a standardized protocol.
- Gain or loss of 3-lines of visual acuity as defined above.
- Change in CNV size according to fluorescein angiogram, following a standardized protocol.
- Presence or intraretinal fluid, sub-retinal fluid, or pigment epithelial detachment . [ Time Frame: at week 28 ]
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): NCT01918878
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Itay Chowers, Prof.||Hadassah Medical Organization|