Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis
Primary Purpose
Presumed Ocular Histoplasmosis (POHS)
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
verteporfin
Sponsored by
About this trial
This is an interventional treatment trial for Presumed Ocular Histoplasmosis (POHS) focused on measuring Histoplasmosis
Eligibility Criteria
Inclusion Criteria:
- Subfoveal CNV due to presumed ocular histoplasmosis of less than 1 year duration
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age greater than or equal to 21 years of age
- CNV lesion of than < 5400 microns in diameter
- Best corrected visual acuity of 20/40-20/320
- Birth control therapy for females of child-bearing potential
Exclusion Criteria:
- Subfoveal NCV due tp presumed ocular histoplasmosis for > 1 year
- Pregnancy or lactation premenopausal women not using adequate contraception
- Prior enrollment in the study
- Any other condition that the Investigator believes would pose a significant hazard to the subject
- Participation in another simultaneous medical investigation or trial
- Participation in another trial or previous trial of ranibizumab or Avastin
- Any concurrent ocular condition in the study eye (cataract, diabetic retinopathy)that could require medical or surgical intervention or ifa allowed to progress, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period
- Previous panretinal photocoagulation
- Previous steroids or PDT in 3 months
- Previous participation in any studies of investigational drugs within 30 days preceding Day 0
- Prior participation in a Genentech ranibizumab clinical trial
- Previous treatment with intravitreally (in either eye) or intravenously administered Avastin within 3 months
- Previous use of Macugen in the study eye within 3 months
- Prior submacular surgery
Sites / Locations
- Macula-Retina-Vitreous Service, Midwest Eye InstituteRecruiting
- Barnes Retina InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ranibizumab intravitreal injection
Photodynamic Therapy
Arm Description
0.5 mg intravitreal injection of ranibizumab
Photodynamic therapy with Visudyne
Outcomes
Primary Outcome Measures
Mean change in visual acuity
Secondary Outcome Measures
To evaluate mean change in vision at 6 months
Full Information
NCT ID
NCT00546936
First Posted
October 17, 2007
Last Updated
April 15, 2009
Sponsor
Barnes Retina Institute
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00546936
Brief Title
Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis
Official Title
Ranibizumab vs PDT for Presumed Ocular Histoplasmosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
April 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Barnes Retina Institute
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the change in visual activity of ranibizumab to Photodynamic Therapy (PDT)in patients with choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presumed Ocular Histoplasmosis (POHS)
Keywords
Histoplasmosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ranibizumab intravitreal injection
Arm Type
Experimental
Arm Description
0.5 mg intravitreal injection of ranibizumab
Arm Title
Photodynamic Therapy
Arm Type
Active Comparator
Arm Description
Photodynamic therapy with Visudyne
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Intervention Description
0.5mg ranibizumab
Intervention Type
Drug
Intervention Name(s)
verteporfin
Other Intervention Name(s)
Visudyne
Intervention Description
Photodynamic therapy with verteporfin every 3 months for 1 year
Primary Outcome Measure Information:
Title
Mean change in visual acuity
Time Frame
6 months, 1 year
Secondary Outcome Measure Information:
Title
To evaluate mean change in vision at 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subfoveal CNV due to presumed ocular histoplasmosis of less than 1 year duration
Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age greater than or equal to 21 years of age
CNV lesion of than < 5400 microns in diameter
Best corrected visual acuity of 20/40-20/320
Birth control therapy for females of child-bearing potential
Exclusion Criteria:
Subfoveal NCV due tp presumed ocular histoplasmosis for > 1 year
Pregnancy or lactation premenopausal women not using adequate contraception
Prior enrollment in the study
Any other condition that the Investigator believes would pose a significant hazard to the subject
Participation in another simultaneous medical investigation or trial
Participation in another trial or previous trial of ranibizumab or Avastin
Any concurrent ocular condition in the study eye (cataract, diabetic retinopathy)that could require medical or surgical intervention or ifa allowed to progress, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period
Previous panretinal photocoagulation
Previous steroids or PDT in 3 months
Previous participation in any studies of investigational drugs within 30 days preceding Day 0
Prior participation in a Genentech ranibizumab clinical trial
Previous treatment with intravitreally (in either eye) or intravenously administered Avastin within 3 months
Previous use of Macugen in the study eye within 3 months
Prior submacular surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ginny S Nobel, COT
Phone
314-367-1278
Ext
2305
Email
bristudy@barnesretinainstitute.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Walters, COT
Phone
314-367-1278
Ext
2312
Email
bristudy@barnesretinainstitute.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin J. Blinder, MD
Organizational Affiliation
Barnes Retina Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Macula-Retina-Vitreous Service, Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neelam Thukral
Phone
317-805-2152
Email
neelamt@midwest.com
First Name & Middle Initial & Last Name & Degree
Thomas Ciulla, MD
Facility Name
Barnes Retina Institute
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ginny S Nobel, COT
Phone
314-367-1278
Ext
2305
Email
bristudy@barnesretinainstitute.com
First Name & Middle Initial & Last Name & Degree
Carol L Walters, COT
Phone
314-367-2287
Ext
2312
Email
bristudy@barnesretinainstitute.com
First Name & Middle Initial & Last Name & Degree
Kevin J Blinder, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
23410808
Citation
Ramaiya KJ, Blinder KJ, Ciulla T, Cooper B, Shah GK. Ranibizumab versus photodynamic therapy for presumed ocular histoplasmosis syndrome. Ophthalmic Surg Lasers Imaging Retina. 2013 Jan-Feb;44(1):17-21. doi: 10.3928/23258160-20121221-07.
Results Reference
derived
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Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis
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