Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

Overview

This Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 2.0mg Ranibizumab in three monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.

Full Title of Study: “Treatment of Polypoidal Choroidal Vasculopathy With High Dose Ranibizumab (Lucentis): A Phase I Safety Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2015

Detailed Description

Twenty eyes will be randomized will receive 3 consecutive monthly intravitreal 2.0 mg/0.5mg (3:1 ratio) Ranibizumab injection with the first injection occuring at Day 0 and second and third injection occuring at month 1 and month 2 respectively. Retreatment with intravitreal Ranibizumab or other therapies will be at the investigators discretion but guidelines for recommended retreatment.

Interventions

  • Drug: ranibizumab 0.5 or 2.0 mg/0.05 cc
    • ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.

Arms, Groups and Cohorts

  • Experimental: Ranibizumab 2.0 mg
    • Intraocular injection of 2.0 mg/0.05 cc ranibizumab.
  • Active Comparator: Ranibizumab 0.5 mg
    • Intraocular injection of 0.5 mg/0.05 cc ranibizumab.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence and severity of ocular and systemic adverse events will be compared between the 2.0mg and 0.5 mg groups.
    • Time Frame: 2 years
    • Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more clinical macula (arcade to arcade), disease related vitreous hemorrhage, injection-related endophthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure – related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.

Participating in This Clinical Trial

Inclusion Criteria

  • Males and Females >18 years of age. Females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control. – ICG and fluorescein angiographic characteristics consistent with active, leaking PCV with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, PED or fluid diagnosed within the past 6 months or diagnosed as newly active within the past 6 months. Subjects who completed the 24 month follow up in the original FVF3671s protocol may enter the study without necessarily demonstrating active exudative PCV at enrollment. – Best-Corrected ETDRS Visual Acuity at 4 meters between 20/20 – 20/800. – Lesion size – no limitations. – Lesions Characteristics – leaking lesions consistent with PCV. No limitations on hemorrhage, fibrosis or atrophy. – No therapy (includes non foveal laser, PDT, intravitreal steroids, TTT, radiotherapy, or anti-VEGF therapy) or intraocular surgery within the past 30 days for any condition. – Clear ocular media to allow for photography/angiography. – Ability to provide written informed consent and comply with study assessments for the full duration of the study. Exclusion Criteria:

  • Patients with features of age related macular degeneration such as abundant drusen and demographic features consistent with this diagnosis. – Allergy to Fluorescein, ICG, Iodine, Shellfish. – Pregnancy (positive pregnancy test) – Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. – Participation in another simultaneous medical investigation or trial. – Exclude other anti-VEGF agents as therapy options. – History of previous subfoveal laser. – Advanced glaucoma (IOP > 25 or cup/disc ration > 0.8) – Any condition in the opinion of the investigator that would interfere with disease status/progression or jeopardize patients' participation in the study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Southeast Retina Center, Georgia
  • Collaborator
    • Genentech, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dennis M. Marcus, M.D., Dr. Dennis M. Marcus Principal Investigator – Southeast Retina Center, Georgia
  • Overall Official(s)
    • Dennis M. Marcus, M.D., Principal Investigator, Southeast Retina Center

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