Clinical Trial: Intravitreal Bevacizumab vs.Combination Therapy for CNV Due to Other Than AMD

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Pilot Study of Intravitreal Bevacizumab vs. Combination Therapy for Choroidal Neovascularization Secondary to Causes Other Than Age-related Macular Degeneration

Brief Summary: Anti-VEGF therapy has been proven efficacious for the wet (neovascular) form of macular degeneration and may be beneficial for the treatment of choroidal neovascularization (CNV) due to other causes. The limitation of this type of treatment is the necessity for frequent intraocular injections. The purpose of this study is to determine if using anti-VEGF therapy in combination with photodynamic therapy can reduce the number of treatments needed with monotherapy while achieving similar visual results. There are ongoing multicenter trials evaluating combination therapy in patients with wet AMD but no similar trial for patients with CNV due to non-AMD causes. Therefore, in this study the investigators will focus on patients with CNV not due to AMD.

Detailed Summary:
Sponsor: Massachusetts Eye and Ear Infirmary

Current Primary Outcome: Mean number of treatments per group [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Mean change in visual acuity from baseline [ Time Frame: 12 months ]

Mean change in visual acuity from baseline

  • Proportion of subjects losing ≤8 letters (≈1.5 lines) from baseline
  • Proportion gaining ≥15 letters from baseline
  • Proportion with a Snellen equivalent of 20/200 or worse (legal blindness = 20/200 or worse in both eyes)
  • Mean change from baseline in total area of CNV and total area of leakage from CNV from baseline to month 12 by FA Mean change in central subfield macular thickness (CMT) measured by OCT from baseline to month 12 Change of in areas of hypoautofluorescence (indicating atrophy) from baseline to month 12


Original Secondary Outcome: Same as current

Information By: Massachusetts Eye and Ear Infirmary

Dates:
Date Received: October 29, 2010
Date Started: August 2010
Date Completion: September 2013
Last Updated: January 13, 2014
Last Verified: January 2014