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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01469156
Other study ID # FVF4916s
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date September 2011
Est. completion date February 2015

Study information

Verified date November 2022
Source Southeast Retina Center, Georgia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
United States Southeast Retina Center Augusta Georgia

Sponsors (2)

Lead Sponsor Collaborator
Southeast Retina Center, Georgia Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more clinical macula (arcade to arcade), disease related vitreous hemorrhage, injection-related endophthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure - related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs. 2 years
Secondary Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months 12 months
Secondary Change in Mean Central Foveal Thickness From Baseline 12 Months
Secondary Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months 12 Months
Secondary Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters 3 Months
Secondary Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters 6 months
Secondary Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters 9 Months
Secondary Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters 12 Months
Secondary Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12 12 months
Secondary Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters 3 months
Secondary Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters 6 months
Secondary Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters 9 months
Secondary Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters 12 months
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