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Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Barnes Retina Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Barnes Retina Institute
ClinicalTrials.gov Identifier:
NCT00546936
First received: October 17, 2007
Last updated: April 15, 2009
Last verified: April 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ranibizumab vs PDT for Presumed Ocular Histoplasmosis

Resource links provided by NLM:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.
Investigators
Principal Investigator: Kevin J. Blinder, MD Barnes Retina Institute
  More Information

No publications provided by Barnes Retina Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin Blinder, MD, Barnes Retina Institute
ClinicalTrials.gov Identifier: NCT00546936     History of Changes
Other Study ID Numbers: FVF4145s
Study First Received: October 17, 2007
Last Updated: April 15, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Barnes Retina Institute:
Histoplasmosis

Additional relevant MeSH terms:
Histoplasmosis
Mycoses
Verteporfin
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014