Clinical trial NCT00546936: Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis
Official title: Ranibizumab vs PDT for Presumed Ocular Histoplasmosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Presumed Ocular Histoplasmosis (POHS)
Keywords: Histoplasmosis
Lead sponsor: Barnes Retina Institute
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Mean change in visual acuity
timeFrame: 6 months, 1 year
Secondary outcomes:
measure: To evaluate mean change in vision at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Macula-Retina-Vitreous Service, Midwest Eye Institute
state: Indiana
city: St. Louis
country: United States
facility: Barnes Retina Institute
state: Missouri
Study officials:
affiliation: Barnes Retina Institute
name: Kevin J. Blinder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramaiya KJ, Blinder KJ, Ciulla T, Cooper B, Shah GK. Ranibizumab versus photodynamic therapy for presumed ocular histoplasmosis syndrome. Ophthalmic Surg Lasers Imaging Retina. 2013 Jan-Feb;44(1):17-21. doi: 10.3928/23258160-20121221-07.