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

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Southeast Clinical Research Associates, LLC
Study ID
NCT03071055
Phase
PHASE2
Status
Completed

Conditions

  • Exudative Age Related Macular Degeneration

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

First listed
Mar 6, 2017
Start date
Oct 1, 2017
Status verified
Oct 2020
Primary completion
Jun 3, 2019
Completion
Jun 3, 2019

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: ranibizumab
    ranibizumab 0.5mg in commercially available vial
  • Experimental: ranibizumab pre filled-syringe
    ranibizumab 0.5mg in soon to be available pre-filled syringe

Primary Outcome Measure

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

Locations (2)

FacilityCityStateZIPSite coordinators
Charlotte Eye Ear Nose and Throat Associates, PACharlotteNorth Carolina28210-
Charlotte Eye Ear Nose and Throat Associates, PAStatesvilleNorth Carolina28677-

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