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

Primary Purpose

Neovascular Age-Related Macular Degeneration

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Bevacizumab (Avastin), Verteporfin (Visudyne)
Sponsored by
University of Padova
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-Related Macular Degeneration focused on measuring Age-Related Macular Degeneration, Choroidal Neovascularization, Bevacizumab, Photodynamic Therapy

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Ophthalmology, University of PadovaRecruiting

Outcomes

Primary Outcome Measures

Number of Bevacizumab injections
The mean change in best-corrected ETDRS visual acuity in the study eye

Secondary Outcome Measures

Mean change in total CNV area (Disc Areas)
Changes of central retinal thickness measured by Optical Coherence Tomography (OCT).
NEI VFQ-25 (vision-related quality of life) score
Pelli-Robson Contrast Sensitivity Score

Full Information

First Posted
June 10, 2008
Last Updated
June 10, 2008
Sponsor
University of Padova
Collaborators
Department of Ophthalmology, Conegliano Hospital, Treviso, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT00696592
Brief Title
Photodynamic Therapy Combined With Bevacizumab vs Bevacizumab Alone for Neovascular Age-Related Macular Degeneration
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Padova
Collaborators
Department of Ophthalmology, Conegliano Hospital, Treviso, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-Related Macular Degeneration
Keywords
Age-Related Macular Degeneration, Choroidal Neovascularization, Bevacizumab, Photodynamic Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bevacizumab (Avastin), Verteporfin (Visudyne)
Primary Outcome Measure Information:
Title
Number of Bevacizumab injections
Time Frame
One year
Title
The mean change in best-corrected ETDRS visual acuity in the study eye
Time Frame
Months 6 and 12
Secondary Outcome Measure Information:
Title
Mean change in total CNV area (Disc Areas)
Time Frame
Months 6 and 12
Title
Changes of central retinal thickness measured by Optical Coherence Tomography (OCT).
Time Frame
Months 6 and 12
Title
NEI VFQ-25 (vision-related quality of life) score
Time Frame
One year
Title
Pelli-Robson Contrast Sensitivity Score
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Lo Giudice, M.D.
Phone
0039049 2050153
Email
gvofta@libero.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Piermarocchi, M.D.
Organizational Affiliation
University of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, University of Padova
City
Padova
State/Province
PD
ZIP/Postal Code
35100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Lo Giudice, M.D.
Phone
0039049 2050153
Email
gvofta@libero.it
First Name & Middle Initial & Last Name & Degree
Stefano Piermarocchi, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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