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Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Southeast Retina Center, Georgia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
Southeast Retina Center, Georgia
ClinicalTrials.gov Identifier:
NCT00837330
First received: February 4, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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 (PCV)
 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: Single Group 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:

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

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

Primary Outcome Measures:
  • best-corrected ETDRS acuity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • macular thickness (central subfield thickness), as measured by optical coherence tomography [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complications, such as infection, drug reaction, retinal tear or detachment, loss of vision not attributable to disease process, cataract formation, significant change in intraocular pressure, intraocular bleeding [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: March 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab
Intraocular injection of 0.5 or 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 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, best-corrected ETDRS visual acuity (BCVA), intraocular pressure measurement, complete ophthalmologic examination, fundus photography, fluorescein/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
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
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./Principal Investigator, Southeast Retina Center
ClinicalTrials.gov Identifier: NCT00837330     History of Changes
Other Study ID Numbers: FVF3761s
Study First Received: February 4, 2009
Last Updated: February 4, 2009
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 16, 2013