Study Detail: Eye Drops for CNV

Trial Description Summary : A study to evaluate if daily-dosed (4x day) pazopanib eye drops can maintain or improve vision while reducing the need for IVT (intravitreal) injections.

Basic Trial Information
Phase: 2b 
Disease: Wet Macular Degeneration
Sponsor: GSK (GlaxoSmithKline)
Protocol Number: GSK MD7110852
Status: Enrolling

Study Duration: 1 year plus 7-14 day screening period  

Eligibility Criteria:

 Inclusion Criteria
  •Subfoveal CNV, secondary to  AMD with evidence of SR or IR fluid by OCT and center point thickness of > 250 microns on the   Stratus OCT and >300 on the Cirrus OCT.
  • At least 3 prescreening IVT of LUC, AVA or MAC. At least 2 of the last 3 must be done within last 6 mo.
  • Previous response to IVT inj in the judgment of the investigator
  • Continued need for IVT inj  and expected likelihood to benefit
  • VA  approx 20/32-20/320

  Exclusion Criteria
  • IVT steroids, laser, PDT, TTT, sub mac sx or other unapproved txmts
  • Other ocular sx except cat or yag permitted if  performed > 3mo prior to screening
  • H/O RD
  • >8 diopters of myopia
  • Uncontrolled glaucoma >25mmHg despite txmt with meds
 

General Medical

 • Any uncontrolled medical conditions
 • MI or CVA within 6 mo prior to screening
 • Mean BP ≥150/95 with or without HTN meds (from average of  2 measurements)
 • Active bleeding disorder
 • Major sx  with 1 mo screening
 • Liver function – WNL prior to randomization
 • ECG must be within certain range
 • Systemic anti-VEGF
 • Medications with ocular toxicity

The above inclusion/exclusion criteria is not complete and the study coordinator will do a complete screening.

Study Title : Phase 2b, dose ranging study to evaluate if daily-dosed (QID) pazopanib eye drops can maintain or improve vision while reducing the need for IVT (intravitreal) injections.

Trial Contact Information
Site: Beachwood and Lakewood 
More study contact information:  Kim 216/831-5700