Overview

This trial is active, not recruiting.

Condition polypoidal choroidal vasculopathy
Treatment ranibizumab 0.5 or 2.0 mg/0.05 cc
Phase phase 1/phase 2
Sponsor Southeast Retina Center, Georgia
Collaborator Genentech
Start date September 2011
End date February 2015
Trial size 20 participants
Trial identifier NCT01469156, FVF4916s

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Intraocular injection of 2.0 mg/0.05 cc ranibizumab.
ranibizumab 0.5 or 2.0 mg/0.05 cc Lucentis
ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.
(Active Comparator)
Intraocular injection of 0.5 mg/0.05 cc ranibizumab.
ranibizumab 0.5 or 2.0 mg/0.05 cc Lucentis
ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.

Primary Outcomes

Measure
Incidence and severity of ocular and systemic adverse events will be compared between the 2.0mg and 0.5 mg groups.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Treatment of Polypoidal Choroidal Vasculopathy With High Dose Ranibizumab (Lucentis): A Phase I Safety Study.
Principal investigator Dennis M. Marcus, M.D.
Description Twenty eyes will be randomized will receive 3 consecutive monthly intravitreal 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Southeast Retina Center, Georgia.