Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

This study is currently recruiting participants.

Verified by Barnes Retina Institute, April 2009

First Received: October 17, 2007 Last Updated: April 15, 2009 History of Changes

Sponsors and Collaborators:	Barnes Retina Institute Genentech
Information provided by:	Barnes Retina Institute
ClinicalTrials.gov Identifier:	NCT00546936

Purpose

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

Condition	Intervention	Phase
Presumed Ocular Histoplasmosis (POHS)	Drug: ranibizumab Drug: verteporfin	Phase II

Drug Information available for: Verteporfin Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ranibizumab vs PDT for Presumed Ocular Histoplasmosis

Further study details as provided by Barnes Retina Institute:

Primary Outcome Measures:

Mean change in visual acuity [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate mean change in vision at 6 months [ Time Frame: 6 months ]

Estimated Enrollment:	30
Study Start Date:	October 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ranibizumab intravitreal injection: Experimental 0.5 mg intravitreal injection of ranibizumab	Drug: ranibizumab 0.5mg ranibizumab
Photodynamic Therapy: Active Comparator Photodynamic therapy with Visudyne	Drug: verteporfin Photodynamic therapy with verteporfin every 3 months for 1 year

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546936

Contacts

Contact: Ginny S Nobel, COT	314-367-1278 ext 2305	bristudy@barnesretinainstitute.com
Contact: Carol Walters, COT	314-367-1278 ext 2312	bristudy@barnesretinainstitute.com

Locations

United States, Indiana
Macula-Retina-Vitreous Service, Midwest Eye Institute	Recruiting
Indianapolis, Indiana, United States, 46280
Contact: Neelam Thukral 317-805-2152 neelamt@midwest.com
Principal Investigator: Thomas Ciulla, MD
United States, Missouri
Barnes Retina Institute	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Ginny S Nobel, COT 314-367-1278 ext 2305 bristudy@barnesretinainstitute.com
Contact: Carol L Walters, COT 314-367-2287 ext 2312 bristudy@barnesretinainstitute.com
Principal Investigator: Kevin J Blinder, MD

Sponsors and Collaborators

Barnes Retina Institute

Genentech

Investigators

Principal Investigator:

Kevin J. Blinder, MD

Barnes Retina Institute

More Information

No publications provided

Responsible Party:	Barnes Retina Institute ( Kevin Blinder, MD )
Study ID Numbers:	FVF4145s
Study First Received:	October 17, 2007
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00546936 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Barnes Retina Institute:

Histoplasmosis

Study placed in the following topic categories:

Mycoses
Photosensitizing Agents
Radiation-Sensitizing Agents
Histoplasmosis
Verteporfin

Additional relevant MeSH terms:

Mycoses
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Physiological Effects of Drugs

Histoplasmosis
Verteporfin
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009