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

Sponsor
Southeast Clinical Research Associates, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT03071055
Collaborator
Genentech, Inc. (Industry)
20
Enrollment
2
Locations
2
Arms
20
Actual Duration (Months)
10
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ranibizumab Injection [Lucentis]
 Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Syringe
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Jun 3, 2019
Actual Study Completion Date :
Jun 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: ranibizumab

ranibizumab 0.5mg in commercially available vial

Drug: Ranibizumab Injection [Lucentis]
intravitreal injection
Other Names:
  • Lucentis

    		•
    Experimental: ranibizumab pre filled-syringe

    ranibizumab 0.5mg in soon to be available pre-filled syringe

    Drug: Ranibizumab Injection [Lucentis]
    intravitreal injection
    Other Names:
  • Lucentis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcome measure is mean change in ETDRS BCVA visual acuity [24 weeks]

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

    Secondary Outcome Measures

    1. Proportion of eyes that gain or lose >0 letters at 24 weeks [24 weeks]

      Proportion of eyes that gain or lose >0 letters at 24 weeks

    2. Proportion of eyes that gain or lose > 5 letters at 24 weeks [24 weeks]

      Proportion of eyes that gain or lose > 5 letters at 24 weeks

    3. Proportion of eyes that gain or lose > 10 letters at 24 weeks [24 weeks]

      Proportion of eyes that gain or lose > 10 letters at 24 weeks

    4. Proportion of eyes that gain or lose > 15 letters at 24 weeks [24 weeks]

      Proportion of eyes that gain or lose > 15 letters at 24 weeks

    5. To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting [24 weeks]

      To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting

    6. • Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks [24 weeks]

      • Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age > 50 years

    • Exudative age related macular degeneration in study eye involving the fovea

    • Best Corrected Visual Acuity (by ETDRS) letter score in study eye of < 85 and > 24 (approximate Snellen equivalent 20/20 to 20/320)

    • Persistent intraretinal or subretinal fluid on SD OCT despite a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the in the 6 months preceding enrollment in the study eye

    • At least 30 days from last intravitreal anti-VEGF injection in the study eye

    Exclusion Criteria:

    • Patient who are receiving systemic anti-VEGF or proangiogenic therapy

    • Patients on chronic high doses corticosteroid therapy (> than 10 mg of oral prednisone or equivalent greater than 10 days)

    • Patients on chronic immunosuppressant therapy

    • Patients on drugs known to have toxic side effects on the retina e.g. hydroxychloroquine

    • History of intravitreal corticosteroids in study eye within 4 months of baseline

    • Uncontrolled hypertension (defined as systolic >180 mm Hg and/or diastolic > 100 mm Hg while patient is sitting)

    • History of stroke or APTC event in the previous year

    • Any intraocular surgery in study eye within 90 days of baseline

    • Presence of vitreomacular traction in study eye

    • Presence of significant epiretinal proliferation in study eye

    • Evidence of active infection in either eye

    • Uncontrolled glaucoma in the study eye defined as a pressure > 25 mmHg on maximal medical therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charlotte Eye Ear Nose and Throat Associates, PA Charlotte North Carolina United States 28210
    2 Charlotte Eye Ear Nose and Throat Associates, PA Statesville North Carolina United States 28677

    Sponsors and Collaborators

    • Southeast Clinical Research Associates, LLC
    • Genentech, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrew N. Antoszyk, MD, Medical Doctor, Southeast Clinical Research Associates, LLC
    ClinicalTrials.gov Identifier:
    NCT03071055
    Other Study ID Numbers:
    • ML29459
    First Posted:
    Mar 6, 2017
    Last Update Posted:
    Oct 22, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Andrew N. Antoszyk, MD, Medical Doctor, Southeast Clinical Research Associates, LLC
    Macular Degeneration
    AMD
    Wet AMD
    Lucentis
    Additional relevant MeSH terms:
    Papilledema
    Macular Degeneration
    Wet Macular Degeneration
    Retinal Degeneration
    Ranibizumab

    Study Results

    No Results Posted as of Oct 22, 2020