Photodynamic Therapy Combined With Bevacizumab vs Bevacizumab Alone for Neovascular Age-Related Macular Degeneration (ARMAST)
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|ClinicalTrials.gov Identifier: NCT00696592|
Recruitment Status : Unknown
Verified April 2007 by University of Padova.
Recruitment status was: Recruiting
First Posted : June 12, 2008
Last Update Posted : June 12, 2008
This phase II study was designed to evaluate the safety, tolerability, and efficacy of bevacizumab treatment in conjunction with PDT at the low fluence rate compared with bevacizumab alone or combined with PDT at the standard fluence rate, in patients with all types of choroidal neovascularization secondary to AMD.
Hypothesis: bevacizumab in combination with PDT (low and standard fluence rate) will i) delay time to retreatment, ii) reduce the average number of treatments required compared to bevacizumab alone and iii) at low PDT fluence rate will improve long-term safety profile.
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age-Related Macular Degeneration||Drug: Bevacizumab (Avastin), Verteporfin (Visudyne)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled, Open Label, Phase II Study of Visudyne® Photodynamic Therapy (PDT) Combined With Bevacizumab (Avastin) vs Avastin Alone in Patients With Neovascular Age-Related Macular Degeneration (AMD)|
|Study Start Date :||January 2007|
- Number of Bevacizumab injections [ Time Frame: One year ]
- The mean change in best-corrected ETDRS visual acuity in the study eye [ Time Frame: Months 6 and 12 ]
- Mean change in total CNV area (Disc Areas) [ Time Frame: Months 6 and 12 ]
- Changes of central retinal thickness measured by Optical Coherence Tomography (OCT). [ Time Frame: Months 6 and 12 ]
- NEI VFQ-25 (vision-related quality of life) score [ Time Frame: One year ]
- Pelli-Robson Contrast Sensitivity Score [ Time Frame: One year ]
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): NCT00696592
|Contact: Giuseppe Lo Giudice, M.D.||0039049 firstname.lastname@example.org|
|Department of Ophthalmology, University of Padova||Recruiting|
|Padova, PD, Italy, 35100|
|Contact: Giuseppe Lo Giudice, M.D. 0039049 2050153 email@example.com|
|Principal Investigator: Stefano Piermarocchi, M.D.|
|Principal Investigator:||Stefano Piermarocchi, M.D.||University of Padova|