← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

IVL for OHS Trial 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.Check my eligibility

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.See study design

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.

IVL for OHS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have active eye blood vessel growth due to a fungal infection.

IVL for OHS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

incidence and severity of ocular adverse events as identified by eye examination

incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs

Secondary outcome measures

change in fluorescein angiographic outcomes

mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography

mean change in visual acuity

+1 more

IVL for OHS 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

0 / 2Eligibility criteria met

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

1,539 Previous Clinical Trials

567,669 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has research been conducted on the efficacy of administering medications via monthly injections?

"Presently, a total of 31 research studies involving Monthly injections are active with 15 trials in the final phase. Most of these tests take place at Oak Forest, Illinois yet there exists 814 different sites where such experiments may be conducted."

Answered by AI

Is the recruitment process for this scientific inquiry still open?

"Contrary to what is registered on clinicaltrials.gov, participants are not being accepted into this trial at the moment. It first went up for recruitment in August 1st of 2009, and was last updated a week later. Nevertheless, there still exist 1425 other investigations actively recruiting individuals across different locations."

Answered by AI

How many participants have signed up for this trial?

"At present, this clinical trial is not in need of participants. Initially posted on August 1st 2009 and last edited eight days later, the study has been concluded. However, there are 1394 other trials searching for patients with syndrome and 31 studies looking to enroll those needing monthly injections."

Answered by AI

What conditions can be alleviated by regular injection-based treatments?

"Branch vein occlusion is often addressed with regular injections. However, these same treatments are also known to ameliorate wet age-related macular degeneration (wAMD), macular edema, and myopic choroidal neovascularization."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2009. "Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00955630.

All > Kentucky