Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Dennis M. Marcus, M.D., Southeast Retina Center, Georgia
ClinicalTrials.gov Identifier:
NCT00837330
First received: February 4, 2009
Last updated: September 16, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Southeast Retina Center, Georgia:

Primary Outcome Measures:
  • Commonly Reported and Notable Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided by Southeast Retina Center, Georgia

Additional 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
Study First Received: February 4, 2009
Results First Received: November 3, 2011
Last Updated: September 16, 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 October 20, 2014