Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy
Information source: Southeast Retina Center, Georgia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polypoidal Choroidal Vasculopathy
Intervention: ranibizumab 0.5 or 0.3 mg/0.05 cc (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Southeast Retina Center, Georgia Official(s) and/or principal investigator(s): Dennis M. Marcus, M.D., Principal Investigator, Affiliation: Southeast Retina Center
Summary
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.
Clinical Details
Official title: Treatment of Polypoidal Choroidal Vasculopathy With Ranibizumab(Lucentis): A Phase I/II Safety Study.
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Commonly Reported and Notable Adverse Events
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
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Southeast Retina Center, Augusta, Georgia 30909, United States
Additional Information
Starting date: May 2006
Last updated: November 17, 2014
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