Status:
WITHDRAWN
Photodynamic Therapy Combined With Bevacizumab vs Bevacizumab Alone for Neovascular Age-related Macular Degeneration
Lead Sponsor:
University of Padova
Collaborating Sponsors:
Department of Ophthalmology, Conegliano Hospital, Treviso, Italy
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
55-80 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- All lesion subtype of CNV secondary to age-related macular.
- sub-foveal CNV.
- patients who fail to respond to Photodynamic therapy.
- patients who are not eligible for PDT (Greatest linear dimension of the lesion \>/= 5400 um, CNV with hemorrhage \>/= 50 % of the entire lesion, minimally classic or occult CNV with greatest linear dimension of the lesion \>/= 4600 um.).
- Patients affected by Pigment Epithelium Detachment with CNV.
- Patients affected by Retinal Angiomatous Proliferation.
- Willingness and ability to participate and provide written informed consent.
Exclusion
- Individuals with choroidal neovascularization from causes other than AMD (Myopia, Angioid Streaks).
- Any intraocular surgery within 2 months in the study eye.
- Prior retinal or vitreous surgery including posterior segment vitrectomy or scleral buckling in the study eye.
- Any significant ocular disease that has compromised or could compromise vision in the study eye.
- Prior stroke, myocardial infarction, or end-stage malignancy.
- Active hepatitis or clinically significant liver disease, renal failure.
- Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.
- Patients who are in an experimental therapy study or who have received experimental therapy within the last 12 weeks.
- Patients who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
Key Trial Info
Start Date :
January 31 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00696592
Start Date
January 31 2007
End Date
January 31 2008
Last Update
April 24 2025
Active Locations (1)
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1
Department of Ophthalmology, University of Padova
Padua, PD, Italy, 35100