Ocular Histoplasmosis SyndromePhase 1/2IVL for OHSNCT00955630
Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
A Phase 1/2 study testing ranibizumab in people with Ocular Histoplasmosis Syndrome, run by Retina Associates of Kentucky at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Histoplasmosis Syndrome
- What is being tested?
- ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 or over
- active choroidal neovascularization secondary to ocular histoplasmosis
- Visual acuity between 20/25 and 20/400
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Retina Associates of Kentucky
Lexington, Kentucky, 40509
John Kitchens, MD
Tom Stone, MD
About this study
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.
Read the detailed description
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:
- You are pregnant or intending to become pregnant in the next 12 months or are nursing an infant
- You are under the age of 18
- Conditions
- Ocular Histoplasmosis Syndrome
- Being tested
- ranibizumab
- Keywords
- Histoplasmosis, Lucentis, Ranibizumab, OHS
- Medical subject headings
- Histoplasmosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
3 monthly injections of ranibizumab followed by prn injections for the remainder of the study
ranibizumabDrug
Also called Lucentis
prn injections of ranibizumab throughout the study
| Study group | Role | What they receive |
|---|---|---|
| Monthly injections | Active comparator | 3 monthly injections of ranibizumab followed by prn injections Receives: Drug: ranibizumab |
| PRN injections | Active comparator | injections of ranibizumab on a prn basis from the start of the study Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of ocular adverse events as identified by eye examination
Measured: 1 year
incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs
Measured: 12 mos
Secondary outcomes (4)
mean change in visual acuity
Measured: 1 year
mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography
Measured: 6 and 12 months
change in fluorescein angiographic outcomes
Measured: 12 months
mean number of injections
Measured: 12 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Histoplasmosis SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retina Associates of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- John Kitchens, MD, Principal investigator, Retina Associates of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955630
- Sponsor's protocol ID
- FVF 4147S
- Acronym
- IVL for OHS
- Status last verified
- Aug 2009
- First submitted
- 7 Aug 2009
- Last updated
- 10 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
- ClinicalTrials.gov ID
- NCT00955630
- Acronym / sponsor ID
- IVL for OHS / FVF 4147S
- Conditions
- Ocular Histoplasmosis Syndrome
- Keywords
- Histoplasmosis, Lucentis, Ranibizumab, OHS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Retina Associates of KentuckyUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (estimated)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- You are pregnant or intending to become pregnant in the next 12 months or are nursing an infant
- You are under the age of 18
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monthly injections | Active comparator | Drug: ranibizumab3 monthly injections of ranibizumab followed by prn injections |
| PRN injections | Active comparator | Drug: ranibizumabinjections of ranibizumab on a prn basis from the start of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 or over
- active choroidal neovascularization secondary to ocular histoplasmosis
- Visual acuity between 20/25 and 20/400
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ranibizumabAlso: Lucentis3 monthly injections of ranibizumab followed by prn injections for the remainder of the study | Drug | Monthly injections |
| ranibizumabAlso: Lucentisprn injections of ranibizumab throughout the study | Drug | PRN injections |
Primary outcome
incidence and severity of ocular adverse events as identified by eye examination
Time frame: 1 year
incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs
Time frame: 12 mos
4 secondary outcomes
mean change in visual acuity
Time frame: 1 year
mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography
Time frame: 6 and 12 months
change in fluorescein angiographic outcomes
Time frame: 12 months
mean number of injections
Time frame: 12 mos
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2009.
Related trials for Ocular Histoplasmosis Syndrome
RecruitingPhase 4
A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome
Presumed Ocular Histoplasmosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kitchens, MD principal investigator
Retina Associates of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ranibizumab in people with Ocular Histoplasmosis Syndrome, run by Retina Associates of Kentucky at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Holcomb, COA (859-263-3900 ext. 145, dholcomb@retinaky.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence and severity of ocular adverse events as identified by eye examination (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2009.