Clinical Trial: Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF Therapy Comparing Syringe Preparation Time Using Ranibizumab Vial and Pre-filled Syri

Brief Summary: This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.

Detailed Summary:

This is a 24 week, open-label, non-randomized, phase II study evaluating intravitreal ranibizumab dosed every 14 days in subjects with exudative macular degeneration who have persistent intraretinal or subretinal fluid despite chronic monthly anti-VEGF therapy (>6 months). Subjects must have had a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the 6 months preceding enrollment.

Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every 14 days (± 3 days). Subjects who have resolution of fluid will convert to monthly ranibizumab for the remainder of the study. If fluid recurs, subjects will return to biweekly treatment.

Patients will be assigned to receive treatment with either ranibizumab vial or PFSs so that approximately 10 patients will be treated with each delivery method option, and syringe preparation time (SPT) will be measured by an assistant who will be observing the procedure and timing with an automated stopwatch.


Sponsor: Southeast Clinical Research Associates, LLC

Current Primary Outcome: The primary outcome measure is mean change in ETDRS BCVA visual acuity [ Time Frame: 24 weeks ]

The primary outcome measure is mean change in ETDRS BCVA visual acuity at 24 weeks compared to baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of eyes that gain or lose >0 letters at 24 weeks [ Time Frame: 24 weeks ]
    Proportion of eyes that gain or lose >0 letters at 24 weeks
  • Proportion of eyes that gain or lose > 5 letters at 24 weeks [ Time Frame: 24 weeks ]
    Proportion of eyes that gain or lose > 5 letters at 24 weeks
  • Proportion of eyes that gain or lose > 10 letters at 24 weeks [ Time Frame: 24 weeks ]
    Proportion of eyes that gain or lose > 10 letters at 24 weeks
  • Proportion of eyes that gain or lose > 15 letters at 24 weeks [ Time Frame: 24 weeks ]
    Proportion of eyes that gain or lose > 15 letters at 24 weeks
  • To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting [ Time Frame: 24 weeks ]
    To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting
  • • Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks [ Time Frame: 24 weeks ]
    • Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks


Original Secondary Outcome: Same as current

Information By: Southeast Clinical Research Associates, LLC

Dates:
Date Received: February 24, 2017
Date Started: April 1, 2017
Date Completion: September 30, 2018
Last Updated: February 28, 2017
Last Verified: February 2017