Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

Completed · Phase 1/Phase 2

Conditions studied: Polypoidal Choroidal Vasculopathy

In brief

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-based, as-needed retreatment and 12 month of drug safety follow up in subjects with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.

Key facts

Study ID

NCT01469156

Run by

Southeast Retina Center, Georgia

People needed

20

Starts

2011-09-01

Expected to finish

2015-02-01

Last updated by the study team

2022-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Southeast Retina Center — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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