Recruiting
Phase 2

Ranibizumab vs. PDT

Sponsor:

Barnes Retina Institute

Code:

NCT00546936

Conditions

Presumed Ocular Histoplasmosis (POHS)

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

ranibizumab

verteporfin

Study Details

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

Conditions

Presumed Ocular Histoplasmosis (POHS)

Study ID

NCT00546936

Start date

Oct, 2007

Status verified date

Apr, 2009

Completion date

Apr, 2010

Anticipated

Primary completion date

Oct, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ranibizumab intravitreal injection

0.5 mg intravitreal injection of ranibizumab

active comparator: Photodynamic Therapy

Photodynamic therapy with Visudyne

Interventions

ranibizumab

0.5mg ranibizumab

verteporfin

Photodynamic therapy with verteporfin every 3 months for 1 year

Primary outcome measure

  • Mean change in visual acuity [ Time Frame: 6 months, 1 year ]

Central Contacts and Locations

Central contacts

Ginny S Nobel, COT

314-367-1278bristudy@barnesretinainstitute.com

Carol Walters, COT

314-367-1278bristudy@barnesretinainstitute.com

Locations

Macula-Retina-Vitreous Service, Midwest Eye Institute

Recruiting

Indianapolis, Indiana, United States, 46280

Contacts

Neelam Thukral

317-805-2152neelamt@midwest.com

Principal Investigator:

Thomas Ciulla, MD

Barnes Retina Institute

Recruiting

St. Louis, Missouri, United States, 63110

Contacts

Ginny S Nobel, COT

314-367-1278bristudy@barnesretinainstitute.com

Carol L Walters, COT

314-367-2287bristudy@barnesretinainstitute.com

Principal Investigator:

Kevin J Blinder, MD

More Information

Sponsor

Barnes Retina Institute

Last update posted

Apr 16, 2009

Last verified

Apr, 2009

Keywords

  • Histoplasmosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Barnes Retina Institute on 2009-04-16.