Presumed Ocular Histoplasmosis (POHS) Clinical Trial
Official title:
Ranibizumab vs PDT for Presumed Ocular Histoplasmosis
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
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | April 2010 |
| Est. primary completion date | October 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Macula-Retina-Vitreous Service, Midwest Eye Institute | Indianapolis | Indiana |
| United States | Barnes Retina Institute | St. Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Barnes Retina Institute | Genentech, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change in visual acuity | 6 months, 1 year | No | |
| Secondary | To evaluate mean change in vision at 6 months | 6 months |