Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy
Primary Purpose
Polypoidal Choroidal Vasculopathy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ranibizumab 0.5 or 0.3 mg/0.05 cc
Sponsored by
About this trial
This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy focused on measuring polypoidal choroidal vasculopathy, choroidal neovascularization, ranibizumab, Lucentis
Eligibility 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)
Sites / Locations
- Southeast Retina Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ranibizumab 0.5 mg/ 0.05 cc
Ranibizumab 0.3 mg/ 0.05 cc
Arm Description
Intraocular injection of 0.5 mg/ 0.05 cc ranibizumab
Intraocular injection of 0.3 mg/ 0.05 cc ranibizumab
Outcomes
Primary Outcome Measures
Commonly Reported and Notable Adverse Events
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00837330
First Posted
February 4, 2009
Last Updated
April 8, 2019
Sponsor
Southeast Retina Center, Georgia
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00837330
Brief Title
Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy
Official Title
Treatment of Polypoidal Choroidal Vasculopathy With Ranibizumab(Lucentis): A Phase I/II Safety Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast Retina Center, Georgia
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypoidal Choroidal Vasculopathy
Keywords
polypoidal choroidal vasculopathy, choroidal neovascularization, ranibizumab, Lucentis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab 0.5 mg/ 0.05 cc
Arm Type
Experimental
Arm Description
Intraocular injection of 0.5 mg/ 0.05 cc ranibizumab
Arm Title
Ranibizumab 0.3 mg/ 0.05 cc
Arm Type
Experimental
Arm Description
Intraocular injection of 0.3 mg/ 0.05 cc ranibizumab
Intervention Type
Drug
Intervention Name(s)
ranibizumab 0.5 or 0.3 mg/0.05 cc
Other Intervention Name(s)
Lucentis
Intervention Description
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
Primary Outcome Measure Information:
Title
Commonly Reported and Notable Adverse Events
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis M. Marcus, M.D.
Organizational Affiliation
Southeast Retina Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22990319
Citation
Marcus DM, Singh H, Lott MN, Singh J, Marcus MD. Intravitreal ranibizumab for polypoidal choroidal vasculopathy in non-Asian patients. Retina. 2013 Jan;33(1):35-47. doi: 10.1097/IAE.0b013e3182618be0.
Results Reference
derived
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Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy
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