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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

Page last updated: August 23, 2015

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