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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

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

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Padova
  • Collaborator
    • Department of Ophthalmology, Conegliano Hospital, Treviso, Italy
  • Overall Official(s)
    • Stefano Piermarocchi, M.D., Principal Investigator, University of Padova
  • Overall Contact(s)
    • Giuseppe Lo Giudice, M.D., 0039049 2050153, gvofta@libero.it

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.