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

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

This study is currently recruiting participants.

Verified by University of Padova, April 2007

Sponsors and Collaborators:	University of Padova Department of Ophthalmology, Conegliano Hospital, Treviso, Italy
Information provided by:	University of Padova
ClinicalTrials.gov Identifier:	NCT00696592

Purpose

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	Intervention	Phase
Neovascular Age-Related Macular Degeneration	Drug: Bevacizumab (Avastin), Verteporfin (Visudyne)	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Bevacizumab Verteporfin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by University of Padova:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	80
Study Start Date:	January 2007

Eligibility

Ages Eligible for Study:	55 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696592

Contacts

Contact: Giuseppe Lo Giudice, M.D.

0039049 2050153

gvofta@libero.it

Locations

Italy, PD
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

Investigators

Principal Investigator:

Stefano Piermarocchi, M.D.

University of Padova

More Information

Study ID Numbers:	01-01-ARMAST-2007
Study First Received:	June 10, 2008
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00696592
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Padova:

Age-Related Macular Degeneration
Choroidal Neovascularization
Bevacizumab
Photodynamic Therapy

Study placed in the following topic categories:

Eye Diseases
Verteporfin
Retinal Degeneration
Macular Degeneration
Bevacizumab

Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration
Choroidal Neovascularization

Additional relevant MeSH terms:

Photosensitizing Agents
Radiation-Sensitizing Agents
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009