Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

NCT ID: NCT00546936

Last Updated: 2009-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Presumed Ocular Histoplasmosis (POHS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ranibizumab intravitreal injection

0.5 mg intravitreal injection of ranibizumab

Group Type EXPERIMENTAL

ranibizumab

Intervention Type DRUG

0.5mg ranibizumab

Photodynamic Therapy

Photodynamic therapy with Visudyne

Group Type ACTIVE_COMPARATOR

verteporfin

Intervention Type DRUG

Photodynamic therapy with verteporfin every 3 months for 1 year

Interventions

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ranibizumab

0.5mg ranibizumab

Intervention Type DRUG

verteporfin

Photodynamic therapy with verteporfin every 3 months for 1 year

Intervention Type DRUG

Other Intervention Names

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Visudyne

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Barnes Retina Institute

OTHER

Sponsor Role lead

Responsible Party

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Barnes Retina Institute

Principal Investigators

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Kevin J. Blinder, MD

Role: PRINCIPAL_INVESTIGATOR

Barnes Retina Institute

Locations

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Macula-Retina-Vitreous Service, Midwest Eye Institute

Indianapolis, Indiana, United States

Site Status RECRUITING

Barnes Retina Institute

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ginny S Nobel, COT

Role: CONTACT

314-367-1278 ext. 2305

Carol Walters, COT

Role: CONTACT

314-367-1278 ext. 2312

Facility Contacts

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Neelam Thukral

Role: primary

317-805-2152

Ginny S Nobel, COT

Role: primary

314-367-1278 ext. 2305

Carol L Walters, COT

Role: backup

314-367-2287 ext. 2312

References

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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.

Reference Type DERIVED
PMID: 23410808 (View on PubMed)

Other Identifiers

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FVF4145s

Identifier Type: -

Identifier Source: org_study_id

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