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Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

Primary Purpose

Polypoidal Choroidal Vasculopathy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ranibizumab 0.5 or 2.0 mg/0.05 cc
Sponsored by
Southeast Retina Center, Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy focused on measuring polypoidal choroidal vasculopathy, choroidal neovascularization, ranibizumab, Lucentis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Southeast Retina Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)

Ranibizumab 0.5 mg

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months
Change in Mean Central Foveal Thickness From Baseline
Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months
Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12
Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters

Full Information

First Posted
November 3, 2011
Last Updated
November 11, 2022
Sponsor
Southeast Retina Center, Georgia
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01469156
Brief Title
Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy
Official Title
Treatment of Polypoidal Choroidal Vasculopathy With High Dose Ranibizumab (Lucentis): A Phase I Safety Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast Retina Center, Georgia
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypoidal Choroidal Vasculopathy
Keywords
polypoidal choroidal vasculopathy, choroidal neovascularization, ranibizumab, Lucentis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)
Arm Type
Experimental
Arm 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
Arm Title
Ranibizumab 0.5 mg
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
ranibizumab 0.5 or 2.0 mg/0.05 cc
Other Intervention Name(s)
Lucentis
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months
Time Frame
12 months
Title
Change in Mean Central Foveal Thickness From Baseline
Time Frame
12 Months
Title
Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months
Time Frame
12 Months
Title
Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Time Frame
3 Months
Title
Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Time Frame
6 months
Title
Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Time Frame
9 Months
Title
Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Time Frame
12 Months
Title
Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12
Time Frame
12 months
Title
Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
Time Frame
3 months
Title
Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
Time Frame
6 months
Title
Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
Time Frame
9 months
Title
Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis M. Marcus, M.D.
Organizational Affiliation
Southeast Retina Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

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