Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Southeast Retina Center, Georgia
Study ID
NCT00837330
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Polypoidal Choroidal Vasculopathy

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ranibizumab 0.5 or 0.3 mg/0.05 cc — DRUG
    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

Study Details

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.

Key Dates

First listed
Feb 5, 2009
Start date
May 31, 2006
Status verified
Apr 2019
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab 0.5 mg/ 0.05 cc
    Intraocular injection of 0.5 mg/ 0.05 cc ranibizumab
  • Experimental: Ranibizumab 0.3 mg/ 0.05 cc
    Intraocular injection of 0.3 mg/ 0.05 cc ranibizumab

Primary Outcome Measure

Commonly Reported and Notable Adverse Events [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Southeast Retina CenterAugustaGeorgia30909-

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