Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)
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|ClinicalTrials.gov Identifier: NCT00775411|
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : September 3, 2012
Last Update Posted : September 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Choroidal Neovascularization Age-Related Maculopathy||Drug: dexamethasone Biological: ranibizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||April 2010|
Experimental: 700 µg dexamethasone and ranibizumab
700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
700 µg dexamethasone intravitreal injection at Day 1 in the study eye.
Other Name: Posurdex
Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
Other Name: Lucentis®
- Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 [ Time Frame: Baseline, Week 4 ]Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.
- Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26 [ Time Frame: Baseline, Week 26 ]BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
- Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26 [ Time Frame: Baseline, Week 26 ]Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased >=10%), Unchanged (Leakage area changed < 10%) and Worsened (Leakage area increased >=10%).
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): NCT00775411
|United States, Texas|
|San Antonio, Texas, United States|
|Australia, New South Wales|
|Sydney, New South Wales, Australia|
|Study Director:||Medical Director||Allergan|