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Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

This study is currently recruiting participants.
Verified November 2011 by Southeast Retina Center, Georgia
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Dennis M. Marcus, M.D., Southeast Retina Center, Georgia
ClinicalTrials.gov Identifier:
NCT01469156
First received: November 3, 2011
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Polypoidal Choroidal Vasculopathy
 Drug: ranibizumab 0.5 or 2.0 mg/0.05 cc
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Polypoidal Choroidal Vasculopathy With High Dose Ranibizumab (Lucentis): A Phase I Safety Study.

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Southeast Retina Center, Georgia:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab 2.0 mg
Intraocular injection of 2.0 mg/0.05 cc ranibizumab.
 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.
Other Name: Lucentis
Active Comparator: Ranibizumab 0.5 mg
Intraocular injection of 0.5 mg/0.05 cc ranibizumab.
 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.
Other Name: Lucentis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469156

Contacts
Contact: Dennis M Marcus, M.D. 706-650-0061 dmarcus@southeastretina.com

Locations
United States, Georgia
Southeast Retina Center Recruiting
Augusta, Georgia, United States, 30909
Contact: Dennis M Marcus, M.D.     706-650-0061     dmarcus@southeastretina.com    
Sub-Investigator: Harinderjit Singh, M.D.            
Principal Investigator: Dennis M Marcus, M.D.            
Sponsors and Collaborators
Southeast Retina Center, Georgia
Genentech
Investigators
Principal Investigator: Dennis M. Marcus, M.D. Southeast Retina Center
  More Information

No publications provided

Responsible Party: Dennis M. Marcus, M.D., Dr. Dennis M. Marcus Principal Investigator, Southeast Retina Center, Georgia
ClinicalTrials.gov Identifier: NCT01469156     History of Changes
Other Study ID Numbers: FVF4916s
Study First Received: November 3, 2011
Last Updated: November 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Southeast Retina Center, Georgia:
polypoidal choroidal vasculopathy
choroidal neovascularization
ranibizumab
Lucentis

ClinicalTrials.gov processed this record on May 23, 2013