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

Neovascular Age-Related Macular Degeneration Clinical Trial

— ARMAST  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00696592
• Other study ID #: 01-01-ARMAST-2007
• Status: Recruiting
• Phase: Phase 2
• First received: June 10, 2008
• Last updated: June 10, 2008
• Start date: January 2007

Study information

• Verified date: April 2007
• Source: University of Padova
• Contact: Giuseppe Lo Giudice, M.D.
• Phone: 0039049 2050153
• Email: gvofta[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Bevacizumab (Avastin), Verteporfin (Visudyne)

Locations

Country	Name	City	State
Italy	Department of Ophthalmology, University of Padova	Padova	PD

Sponsors (2)

Lead Sponsor	Collaborator
University of Padova	Department of Ophthalmology, Conegliano Hospital, Treviso, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Bevacizumab injections		One year
Primary	The mean change in best-corrected ETDRS visual acuity in the study eye		Months 6 and 12
Secondary	Mean change in total CNV area (Disc Areas)		Months 6 and 12
Secondary	Changes of central retinal thickness measured by Optical Coherence Tomography (OCT).		Months 6 and 12
Secondary	NEI VFQ-25 (vision-related quality of life) score		One year
Secondary	Pelli-Robson Contrast Sensitivity Score		One year