Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

This study is ongoing, but not recruiting participants.
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: February 19, 2014
Last verified: February 2014
  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:


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: February 2015
Estimated Primary Completion Date: February 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Southeast Retina Center
Augusta, Georgia, United States, 30909
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: February 19, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014