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Monoclonal Antibodies

Ranibizumab for Ocular Histoplasmosis (IVL for OHS Trial)

Phase 1 & 2
Waitlist Available
Led By John Kitchens, MD
Research Sponsored by Retina Associates of Kentucky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or over
Diagnosis of active choroidal neovascularization secondary to ocular histoplasmosis
Must not have
Premenopausal women not using contraception
Prior treatment with subfoveal thermal laser
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will test if intravitreal ranibizumab (Lucentis) is safe and effective in patients with ocular histoplasmosis who have fluid and blood leakage in their eyes.

Who is the study for?
This trial is for adults over 18 with ocular histoplasmosis causing fluid and blood leakage in the eyes, who have a certain level of visual acuity. It's not for those pregnant, nursing, or planning pregnancy soon; women not on birth control; anyone treated with subfoveal thermal laser; allergic to sodium fluorescein; or in another study.
What is being tested?
The trial tests intravitreal ranibizumab (Lucentis) injections directly into the eye to see if they're safe and can stop fluid and blood leakage caused by ocular histoplasmosis. Participants will receive this medication to assess its effectiveness.
What are the potential side effects?
Ranibizumab may cause eye irritation, increased intraocular pressure, bleeding inside the eye, inflammation or infection. Systemic side effects are rare but might include stroke or heart attack.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have active eye blood vessel growth due to a fungal infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a premenopausal woman not using birth control.
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I have had laser treatment directly on the center of my vision.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: PRN injectionsActive Control1 Intervention
injections of ranibizumab on a prn basis from the start of the study
Group II: Monthly injectionsActive Control1 Intervention
3 monthly injections of ranibizumab followed by prn injections

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Retina Associates of KentuckyLead Sponsor
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,980 Total Patients Enrolled
John Kitchens, MDPrincipal InvestigatorRetina Associates of Kentucky

Media Library

Ranibizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00955630 — Phase 1 & 2
Ranibizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00955630 — Phase 1 & 2
~1 spots leftby Jan 2026
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