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
Recruitment status was Recruiting
Sponsor:
Barnes Retina Institute
Collaborator:
Genentech
Information provided by:
Barnes Retina Institute
ClinicalTrials.gov Identifier:
NCT00546936
First received: October 17, 2007
Last updated: April 15, 2009
Last verified: April 2009
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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
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 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 Photosensitizing Agents Radiation-Sensitizing Agents |
Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013