Photodynamic Therapy Combined With Bevacizumab vs Bevacizumab Alone for Neovascular Age-related M… (NCT00696592) | Clinical Trial Compass
WithdrawnPhase 2
Photodynamic Therapy Combined With Bevacizumab vs Bevacizumab Alone for Neovascular Age-related Macular Degeneration
Stopped: new data from clinical trials
Italy0Started 2007-01-31
Plain-language 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.
Who can participate
Age range
55 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Bevacizumab injections
Timeframe: One year
2
The mean change in best-corrected ETDRS visual acuity in the study eye