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

NCT ID: NCT00696592

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-01-31

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.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BVZ and PDT

Group Type: EXPERIMENTAL

Bevacizumab (Avastin), Verteporfin (Visudyne)

Intervention Type: DRUG

BVZ only

Group Type: ACTIVE_COMPARATOR

Bevacizumab (Avastin), Verteporfin (Visudyne)

Intervention Type: DRUG

Interventions

Bevacizumab (Avastin), Verteporfin (Visudyne)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Ophthalmology, Conegliano Hospital, Treviso, Italy

UNKNOWN

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Stefano Piermarocchi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Piermarocchi, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

Department of Ophthalmology, University of Padova

Padua, PD, Italy

Countries

Italy

Other Identifiers

01-01-ARMAST-2007

Identifier Type: -

Identifier Source: org_study_id