Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

Southeast Retina Center, Georgia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Polypoidal Choroidal Vasculopathy

Treatments: Drug: ranibizumab 0.5 or 2.0 mg/0.05 cc

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01469156

FVF4916s

Details and patient eligibility

About

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.

Full 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 injection occuring at month 1 and month 2 respectively. Retreatment with intravitreal Ranibizumab or other therapies will be at the investigators discretion but guidelines for recommended retreatment.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)

Experimental group

Description:

Intraocular injection of 1.0 or 2.0 mg/0.05 cc ranibizumab. Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met

Treatment:

Drug: ranibizumab 0.5 or 2.0 mg/0.05 cc

Ranibizumab 0.5 mg

Active Comparator group

Description:

Intraocular injection of 0.5 mg/0.05 cc ranibizumab. Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met

Treatment:

Drug: ranibizumab 0.5 or 2.0 mg/0.05 cc