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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071055
Recruitment Status : Completed
First Posted : March 6, 2017
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Andrew N. Antoszyk, MD, Southeast Clinical Research Associates, LLC

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
Exudative Age Related Macular Degeneration 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.

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Study Type : Interventional  (Clinical Trial)
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 : October 1, 2017
Actual Primary Completion Date : June 3, 2019
Actual Study Completion Date : June 3, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Active Comparator: ranibizumab
ranibizumab 0.5mg in commercially available vial
Drug: Ranibizumab Injection [Lucentis]
intravitreal injection
Other Name: Lucentis

Experimental: ranibizumab pre filled-syringe
ranibizumab 0.5mg in soon to be available pre-filled syringe
Drug: Ranibizumab Injection [Lucentis]
intravitreal injection
Other Name: Lucentis




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. • 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071055


Locations
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United States, North Carolina
Charlotte Eye Ear Nose and Throat Associates, PA
Charlotte, North Carolina, United States, 28210
Charlotte Eye Ear Nose and Throat Associates, PA
Statesville, North Carolina, United States, 28677
Sponsors and Collaborators
Southeast Clinical Research Associates, LLC
Genentech, Inc.
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Responsible Party: Andrew N. Antoszyk, MD, Medical Doctor, Southeast Clinical Research Associates, LLC
ClinicalTrials.gov Identifier: NCT03071055    
Other Study ID Numbers: ML29459
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Southeast Clinical Research Associates, LLC:
Macular Degeneration
AMD
Wet AMD
Lucentis
Additional relevant MeSH terms:
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Papilledema
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases, Hereditary
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents