search
Back to results

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
Barnes Retina Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presumed Ocular Histoplasmosis (POHS) focused on measuring Histoplasmosis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 17, 2007
Last Updated
April 15, 2009
Sponsor
Barnes Retina Institute
Collaborators
Genentech, Inc.
search

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

Learn more about this trial

Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

We'll reach out to this number within 24 hrs