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

June 10, 2008 updated by: University of Padova

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Giuseppe Lo Giudice, M.D.
  • Phone Number: 0039049 2050153
  • Email: gvofta@libero.it

Study Locations

  • Italy
    • PD
      • Padova, PD, Italy, 35100
        • Recruiting
        • Department of Ophthalmology, University of Padova
        • Contact:
          • Giuseppe Lo Giudice, M.D.
          • Phone Number: 0039049 2050153
          • Email: gvofta@libero.it
        • Principal Investigator:
          • Stefano Piermarocchi, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in total CNV area (Disc Areas)
Time Frame: Months 6 and 12
Months 6 and 12
Changes of central retinal thickness measured by Optical Coherence Tomography (OCT).
Time Frame: Months 6 and 12
Months 6 and 12
NEI VFQ-25 (vision-related quality of life) score
Time Frame: One year
One year
Pelli-Robson Contrast Sensitivity Score
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Collaborators

Department of Ophthalmology, Conegliano Hospital, Treviso, Italy

Investigators

  • Principal Investigator: Stefano Piermarocchi, M.D., University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Registration Dates

First Submitted

June 10, 2008

First Submitted That Met QC Criteria

June 10, 2008

First Posted (ESTIMATE)

June 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2008

Last Update Submitted That Met QC Criteria

June 10, 2008

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-01-ARMAST-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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