Status:
COMPLETED
Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy
Lead Sponsor:
Southeast Retina Center, Georgia
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Polypoidal Choroidal Vasculopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 1.0 or 2.0mg Ranibizumab in three monthly doses followed by a 9 month period of criteria-bas...
Detailed Description
Twenty eyes will be randomized will receive 3 consecutive monthly intravitreal 1.0 or 2.0 mg/0.5mg (3:1 ratio) Ranibizumab injection with the first injection occuring at Day 0 and second and third inj...
Eligibility Criteria
Inclusion
- Males and Females \>18 years of age. Females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control.
- ICG and fluorescein angiographic characteristics consistent with active, leaking PCV with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, PED or fluid diagnosed within the past 6 months or diagnosed as newly active within the past 6 months. Subjects who completed the 24 month follow up in the original FVF3671s protocol may enter the study without necessarily demonstrating active exudative PCV at enrollment.
- Best-Corrected ETDRS Visual Acuity at 4 meters between 20/20 - 20/800.
- Lesion size - no limitations.
- Lesions Characteristics - leaking lesions consistent with PCV. No limitations on hemorrhage, fibrosis or atrophy.
- No therapy (includes non foveal laser, PDT, intravitreal steroids, TTT, radiotherapy, or anti-VEGF therapy) or intraocular surgery within the past 30 days for any condition.
- Clear ocular media to allow for photography/angiography.
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Exclusion
- Patients with features of age related macular degeneration such as abundant drusen and demographic features consistent with this diagnosis.
- Allergy to Fluorescein, ICG, Iodine, Shellfish.
- Pregnancy (positive pregnancy test)
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- Participation in another simultaneous medical investigation or trial.
- Exclude other anti-VEGF agents as therapy options.
- History of previous subfoveal laser.
- Advanced glaucoma (IOP \> 25 or cup/disc ration \> 0.8)
- Any condition in the opinion of the investigator that would interfere with disease status/progression or jeopardize patients' participation in the study.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01469156
Start Date
September 1 2011
End Date
February 1 2015
Last Update
December 12 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Southeast Retina Center
Augusta, Georgia, United States, 30909