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

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ClinicalTrials.gov Identifier: NCT00696592
Recruitment Status : Unknown
Verified April 2007 by University of Padova.
Recruitment status was:  Recruiting
First Posted : June 12, 2008
Last Update Posted : June 12, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Neovascular Age-Related Macular Degeneration Drug: Bevacizumab (Avastin), Verteporfin (Visudyne) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Number of Bevacizumab injections [ Time Frame: One year ]
  2. The mean change in best-corrected ETDRS visual acuity in the study eye [ Time Frame: Months 6 and 12 ]

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

Eligibility Criteria

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696592

Contact: Giuseppe Lo Giudice, M.D. 0039049 2050153 gvofta@libero.it

Department of Ophthalmology, University of Padova Recruiting
Padova, PD, Italy, 35100
Contact: Giuseppe Lo Giudice, M.D.    0039049 2050153    gvofta@libero.it   
Principal Investigator: Stefano Piermarocchi, M.D.         
Sponsors and Collaborators
University of Padova
Department of Ophthalmology, Conegliano Hospital, Treviso, Italy
Principal Investigator: Stefano Piermarocchi, M.D. University of Padova
More Information

ClinicalTrials.gov Identifier: NCT00696592     History of Changes
Other Study ID Numbers: 01-01-ARMAST-2007
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: June 12, 2008
Last Verified: April 2007

Keywords provided by University of Padova:
Age-Related Macular Degeneration
Choroidal Neovascularization
Photodynamic Therapy

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents