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Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837330
First Posted: February 5, 2009
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Dennis M. Marcus, M.D., Southeast Retina Center, Georgia
  Purpose
This Phase I/II safety study is designed to investigate the safety and efficacy of ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels under the retina. These abnormal blood vessels can bleed or leak fluid, causing disruption of normal retinal function and vision loss. Ranibizumab is a drug that is FDA-approved for the treatment of wet age-related macular degeneration (AMD) and is injected directly into the eye. Given the efficacy of ranibizumab in the treatment of wet AMD, and the postulated similarity between the disease mechanisms involved in both wet AMD and PCV, we believe ranibizumab will have a beneficial effect on visual function in patients with PCV.

Condition Intervention Phase
Polypoidal Choroidal Vasculopathy Drug: ranibizumab 0.5 or 0.3 mg/0.05 cc Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Polypoidal Choroidal Vasculopathy With Ranibizumab(Lucentis): A Phase I/II Safety Study.

Resource links provided by NLM:


Further study details as provided by Dennis M. Marcus, M.D., Southeast Retina Center, Georgia:

Primary Outcome Measures:
  • Commonly Reported and Notable Adverse Events [ Time Frame: 2 years ]
    Incidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, 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.


Enrollment: 20
Study Start Date: May 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab 0.5 mg/ 0.05 cc
Intraocular injection of 0.5 mg/ 0.05 cc ranibizumab
Drug: ranibizumab 0.5 or 0.3 mg/0.05 cc
ranibizumab 0.5 or 0.3 mg/0.05 cc administered intraocularly on a monthly basis for 3 months, followed by monthly examination with the option of further ranibizumab treatment or other therapies at the discretion of the treating physician
Other Name: Lucentis
Experimental: Ranibizumab 0.3 mg/ 0.05 cc
Intraocular injection of 0.3 mg/ 0.05 cc ranibizumab
Drug: ranibizumab 0.5 or 0.3 mg/0.05 cc
ranibizumab 0.5 or 0.3 mg/0.05 cc administered intraocularly on a monthly basis for 3 months, followed by monthly examination with the option of further ranibizumab treatment or other therapies at the discretion of the treating physician
Other Name: Lucentis

Detailed Description:
Please see above description. Phase I/II safety study; prospective, open-label, single-center, non-randomized, uncontrolled, consecutive interventional case series. Enrolled patients are >35 years old and display exudative, active polypoidal choroidal vasculopathy (PCV) in 1 eye. PCV is defined as choroidal neovascularization that displays occult characteristics on fluorescein angiography and polypoidal interconnecting vascular channels with saccular dilatations on indocyanine green angiography and/or fluorescein angiography. Eyes receive 3 consecutive, monthly intravitreal ranibizumab injections (0.5 mg or 0.3 mg/0.05 cc) followed by monthly evaluations with the option of additional intravitreal ranibizumab or alternative treatments at the discretion of the investigator. Baseline and follow-up evaluations include medical history, blood pressure, physical examination, early treatment diabetic rentinopathy study (ETDRS) best-corrected visual acuity (BCVA), intraocular pressure measurement, complete ophthalmologic examination, fundus photography, fluorescein/ indocyanine green (ICG) angiography, and optical coherence tomography (OCT).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age >35 years
  • Exudative, active PCV in 1 eye.
  • PCV is defined as choroidal neovascularization that displays occult characteristics on fluorescein angiography and polypoidal interconnecting vascular channels with saccular dilatations on indocyanine green angiography and/or fluorescein angiography.

Exclusion Criteria:

  • Age <35 years
  • Prior treatment with non-ranibizumab therapies (e.g., laser, surgery, or bevacizumab)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837330


Locations
United States, Georgia
Southeast Retina Center
Augusta, Georgia, United States, 30909
Sponsors and Collaborators
Southeast Retina Center, Georgia
Genentech, Inc.
Investigators
Principal Investigator: Dennis M. Marcus, M.D. Southeast Retina Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dennis M. Marcus, M.D., Dr. Dennis M. Marcus Principal Investigator, Southeast Retina Center, Georgia
ClinicalTrials.gov Identifier: NCT00837330     History of Changes
Other Study ID Numbers: FVF3761s
First Submitted: February 4, 2009
First Posted: February 5, 2009
Results First Submitted: November 3, 2011
Results First Posted: June 23, 2014
Last Update Posted: December 3, 2014
Last Verified: November 2014

Keywords provided by Dennis M. Marcus, M.D., Southeast Retina Center, Georgia:
polypoidal choroidal vasculopathy
choroidal neovascularization
ranibizumab
Lucentis

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents