Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome

NCT ID: NCT00955630

Last Updated: 2009-08-10

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and effectiveness of intravitreal ranibizumab (Lucentis) in patients with fluid and blood leakage in their eyes due to ocular histoplasmosis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients will be evaluated monthly for one year.

Participants will be assigned to one of two groups:

Group A will receive 3 monthly injections of ranibizumab followed by an as needed injection throughout the remainder of the study Group B will receive injections of ranibizumab on an as needed basis throughout the study

You cannot take part in this study if:

1. You are pregnant or intending to become pregnant in the next 12 months or are nursing an infant
2. You are under the age of 18

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ocular Histoplasmosis Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Monthly injections

3 monthly injections of ranibizumab followed by prn injections

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type DRUG

3 monthly injections of ranibizumab followed by prn injections for the remainder of the study

PRN injections

injections of ranibizumab on a prn basis from the start of the study

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type DRUG

prn injections of ranibizumab throughout the study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ranibizumab

3 monthly injections of ranibizumab followed by prn injections for the remainder of the study

Intervention Type DRUG

ranibizumab

prn injections of ranibizumab throughout the study

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lucentis Lucentis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age 18 or over
* active choroidal neovascularization secondary to ocular histoplasmosis
* Visual acuity between 20/25 and 20/400

Exclusion Criteria

* pregnancy or intent to become pregnant within the next 12 months
* nursing an infant
* premenopausal women not using contraception
* prior treatment with subfoveal thermal laser
* allergy to sodium fluorescein simultaneous participation in another investigation or trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Retina Associates of Kentucky

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Retina Associates of Kentucky

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Kitchens, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Associates of Kentucky

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Retina Associates of Kentucky

Lexington, Kentucky, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Diana Holcomb, COA

Role: CONTACT

859-263-3900 ext. 145

Wanda Heath, BS, COT, CCRC

Role: CONTACT

859-263-3900 ext. 106

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FVF 4147S

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lucentis for New Onset Neovascular Glaucoma
NCT00727038 WITHDRAWN PHASE1/PHASE2