Photodynamic Therapy Combined With Bevacizumab vs Bevacizumab Alone for Neovascular Age-related Macular Degeneration

Phase 2

Withdrawn

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: Bevacizumab (Avastin), Verteporfin (Visudyne)

• Registration Number: NCT00696592
• Lead Sponsor: University of Padova

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-31
• Primary Completion: 2008-01-31
• Study Completion: 2008-01-31
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BVZ and PDT	Bevacizumab (Avastin), Verteporfin (Visudyne)	-
BVZ only	Bevacizumab (Avastin), Verteporfin (Visudyne)	-

Primary Outcome Measures

Name	Time	Method
Number of Bevacizumab injections	One year
The mean change in best-corrected ETDRS visual acuity in the study eye	Months 6 and 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Ophthalmology, University of Padova; 🇮🇹 Padova, PD, Italy