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

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

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.

Study Overview

• Status: Completed
• Conditions: Exudative Age Related Macular Degeneration
• Intervention / Treatment: Drug: Ranibizumab Injection [Lucentis]

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose and Throat Associates, PA
    • Statesville, North Carolina, United States, 28677
      • Charlotte Eye Ear Nose and Throat Associates, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome measure is mean change in ETDRS BCVA visual acuity	The primary outcome measure is mean change in ETDRS BCVA visual acuity at 24 weeks compared to baseline.	24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Southeast Clinical Research Associates, LLC
• Collaborators: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): June 3, 2019
• Study Completion (ACTUAL): June 3, 2019

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (ACTUAL): March 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: AMD; Lucentis; Wet AMD; Macular Degeneration
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Retinal Diseases; Eye Diseases, Hereditary; Optic Nerve Diseases; Cranial Nerve Diseases; Macular Degeneration; Wet Macular Degeneration; Retinal Degeneration; Papilledema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: ML29459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No