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

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT01256580
Status
Withdrawn

Conditions

  • Angioid Streaks
  • Central Serous Chorioretinopathy (CSC)
  • Choroidal Neovascularization
  • Multifocal Choroiditis
  • Myopia
  • Ocular Histoplasmosis Syndrome
  • Punctate Inner Choroidopathy (PIC)
  • Trauma, or Hereditary Eye Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 31, 2010
Status verified
Jan 2014
Primary completion
Mar 31, 2013
Completion
Sep 30, 2013

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Monotherapy
    Bevacizumab (Avastin; Genentech, Inc.)1.25 mg by intravitreal injection on day 0 and then prn (as-needed) based on ophthalmic examination and OCT findings
  • Active Comparator: Combination therapy
    Intravitreal injection of bevacizumab 1.25 mg (Avastin; Genentech, Inc.) combined with reduced fluence PDT(Visudyne®; Novartis,) and 200 ug of intravitreal dexamethasone(4mg/ml, American regent, Inc) on Day 0 and then monthly retreatment with bevacizumab as-needed and triple therapy every 3 months as-needed.

Primary Outcome Measure

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

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