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

NCT ID: NCT03071055

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-06-03

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 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.

Conditions

Exudative Age Related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ranibizumab

ranibizumab 0.5mg in commercially available vial

Group Type: ACTIVE_COMPARATOR

Ranibizumab Injection [Lucentis]

Intervention Type: DRUG

intravitreal injection

ranibizumab pre filled-syringe

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

Group Type: EXPERIMENTAL

Ranibizumab Injection [Lucentis]

Intervention Type: DRUG

intravitreal injection

Interventions

Ranibizumab Injection [Lucentis]

intravitreal injection

Intervention Type: DRUG

Other Intervention Names

Lucentis

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Southeast Clinical Research Associates, LLC

OTHER

Sponsor Role: lead

Responsible Party

Andrew N. Antoszyk, MD

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charlotte Eye Ear Nose and Throat Associates, PA

Charlotte, North Carolina, United States

Charlotte Eye Ear Nose and Throat Associates, PA

Statesville, North Carolina, United States

Countries

United States

Other Identifiers

ML29459

Identifier Type: -

Identifier Source: org_study_id