NCT00546936

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 16, 2009

Status Verified

April 1, 2009

Enrollment Period

2 years

First QC Date

October 17, 2007

Last Update Submit

April 15, 2009

Conditions

Presumed Ocular Histoplasmosis (POHS)

Keywords

Histoplasmosis

Outcome Measures

Primary Outcomes (1)

  • Mean change in visual acuity

    6 months, 1 year

Secondary Outcomes (1)

  • To evaluate mean change in vision at 6 months

    6 months

Study Arms (2)

ranibizumab intravitreal injection

EXPERIMENTAL

0.5 mg intravitreal injection of ranibizumab

Drug: ranibizumab

Photodynamic Therapy

ACTIVE COMPARATOR

Photodynamic therapy with Visudyne

Drug: verteporfin

Interventions

ranibizumabDRUG

0.5mg ranibizumab

ranibizumab intravitreal injection
verteporfinDRUG

Photodynamic therapy with verteporfin every 3 months for 1 year

Also known as: Visudyne
Photodynamic Therapy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Macula-Retina-Vitreous Service, Midwest Eye Institute

Indianapolis, Indiana, 46280, United States

RECRUITING

Barnes Retina Institute

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23410808DERIVED

MeSH Terms

Conditions

Histoplasmosis

Interventions

RanibizumabVerteporfin

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Kevin J. Blinder, MD

    Barnes Retina Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ginny S Nobel, COT

CONTACT

314-367-1278bristudy@barnesretinainstitute.com

Carol Walters, COT

CONTACT

314-367-1278bristudy@barnesretinainstitute.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 19, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2009

Study Completion

April 1, 2010

Last Updated

April 16, 2009

Record last verified: 2009-04

Locations

US(2)