Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

NCT ID: NCT01469156

Last Updated: 2022-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-02-28

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-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.

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 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.

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

polypoidal choroidal vasculopathy; choroidal neovascularization; ranibizumab; Lucentis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)

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

Group Type: EXPERIMENTAL

ranibizumab 0.5 or 2.0 mg/0.05 cc

Intervention Type: DRUG

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.

Ranibizumab 0.5 mg

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

Group Type: ACTIVE_COMPARATOR

ranibizumab 0.5 or 2.0 mg/0.05 cc

Intervention Type: DRUG

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.

Interventions

ranibizumab 0.5 or 2.0 mg/0.05 cc

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.

Intervention Type: DRUG

Other Intervention Names

Lucentis

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Southeast Retina Center, Georgia

OTHER

Sponsor Role: lead

Responsible Party

Dennis M. Marcus, M.D.

Dr. Dennis M. Marcus Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis M. Marcus, M.D.

Role: PRINCIPAL_INVESTIGATOR

Southeast Retina Center

Locations

Southeast Retina Center

Augusta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FVF4916s

Identifier Type: -

Identifier Source: org_study_id