Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

• Status: Unknown status
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Southeast Retina Center, Georgia
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.