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Sponsors and Collaborators: |
Barnes Retina Institute Genentech |
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Information provided by: | Barnes Retina Institute |
ClinicalTrials.gov Identifier: | NCT00546936 |
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 |
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Presumed Ocular Histoplasmosis (POHS) |
Drug: ranibizumab Drug: verteporfin |
Phase II |
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 |
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 |
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ranibizumab intravitreal injection: Experimental
0.5 mg intravitreal injection of ranibizumab
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Drug: ranibizumab
0.5mg ranibizumab
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Photodynamic Therapy: Active Comparator
Photodynamic therapy with Visudyne
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Drug: verteporfin
Photodynamic therapy with verteporfin every 3 months for 1 year
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Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Kevin J. Blinder, MD | Barnes Retina Institute |
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 |
Histoplasmosis |
Mycoses Photosensitizing Agents Radiation-Sensitizing Agents Histoplasmosis Verteporfin |
Mycoses Photosensitizing Agents Radiation-Sensitizing Agents Therapeutic Uses Physiological Effects of Drugs |
Histoplasmosis Verteporfin Dermatologic Agents Pharmacologic Actions |