NCT00696592WithdrawnPhase 2
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)
University of Padova1 site in 1 country80 target enrollmentStarted: January 31, 2007Last updated:
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Number of Bevacizumab injections
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
BVZ and PDT
Experimental
Intervention: Bevacizumab (Avastin), Verteporfin (Visudyne) (Drug)
BVZ only
Active Comparator
Intervention: Bevacizumab (Avastin), Verteporfin (Visudyne) (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Mean change in total CNV area (Disc Areas)(Months 6 and 12)
- Changes of central retinal thickness measured by Optical Coherence Tomography (OCT).(Months 6 and 12)
- NEI VFQ-25 (vision-related quality of life) score(One year)
- Pelli-Robson Contrast Sensitivity Score(One year)
Investigators
Stefano Piermarocchi
MD
University of Padova
Study Sites (1)
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