Presumed Ocular Histoplasmosis (POHS)
Conditions
Keywords
Histoplasmosis
Brief summary
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
Interventions
DRUGranibizumab
0.5mg ranibizumab
DRUGverteporfin
Photodynamic therapy with verteporfin every 3 months for 1 year
Sponsors
Genentech, Inc.
Barnes Retina Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in visual acuity | 6 months, 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate mean change in vision at 6 months | 6 months |
Countries
United States
Contacts
Primary ContactGinny S Nobel, COT
Backup ContactCarol Walters, COT
Outcome results
None listed