Presumed Ocular Histoplasmosis (POHS)Phase 2NCT00546936
Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis
A Phase 2 study testing ranibizumab and verteporfin in people with Presumed Ocular Histoplasmosis (POHS), run by Barnes Retina Institute at 2 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Presumed Ocular Histoplasmosis (POHS)
- What is being tested?
- ranibizumab and verteporfin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2007to Apr 2010
- Phase
- Phase 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Macula-Retina-Vitreous Service, Midwest Eye Institute
Indianapolis, Indiana, 46280
Neelam Thukral, 317-805-2152, neelamt@midwest.com
Thomas Ciulla, MD
- Recruiting
Barnes Retina Institute
St Louis, Missouri, 63110
Ginny S Nobel, COT, 314-367-1278 ext. 2305, bristudy@barnesretinainstitute.com
Carol L Walters, COT, 314-367-2287 ext. 2312, bristudy@barnesretinainstitute.com
About this study
Official title: Ranibizumab vs PDT for Presumed Ocular Histoplasmosis
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
- Conditions
- Presumed Ocular Histoplasmosis (POHS)
- Being tested
- ranibizumab, verteporfin
- Keywords
- Histoplasmosis
- Medical subject headings
- Histoplasmosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
0.5mg ranibizumab
verteporfinDrug
Also called Visudyne
Photodynamic therapy with verteporfin every 3 months for 1 year
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab intravitreal injection | Experimental | 0.5 mg intravitreal injection of ranibizumab Receives: Drug: ranibizumab |
| Photodynamic Therapy | Active comparator | Photodynamic therapy with Visudyne Receives: Drug: verteporfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in visual acuity
Measured: 6 months, 1 year
Secondary outcomes (1)
To evaluate mean change in vision at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2009 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Presumed Ocular Histoplasmosis (POHS)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barnes Retina Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Kevin J. Blinder, MD, Principal investigator, Barnes Retina Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546936
- Sponsor's protocol ID
- FVF4145s
- Status last verified
- Apr 2009
- First submitted
- 17 Oct 2007
- Last updated
- 16 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23410808
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab vs PDT for Presumed Ocular Histoplasmosis
- ClinicalTrials.gov ID
- NCT00546936
- Acronym / sponsor ID
- FVF4145s
- Conditions
- Presumed Ocular Histoplasmosis (POHS)
- Keywords
- Histoplasmosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Barnes Retina InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 19 Oct 2007 (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 change in visual activity of ranibizumab to Photodynamic Therapy (PDT)in patients with choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ranibizumab intravitreal injection | Experimental | Drug: ranibizumab0.5 mg intravitreal injection of ranibizumab |
| Photodynamic Therapy | Active comparator | Drug: verteporfinPhotodynamic therapy with Visudyne |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| ranibizumab0.5mg ranibizumab | Drug | ranibizumab intravitreal injection |
| verteporfinAlso: VisudynePhotodynamic therapy with verteporfin every 3 months for 1 year | Drug | Photodynamic Therapy |
Primary outcome
Mean change in visual acuity
Time frame: 6 months, 1 year
1 secondary outcome
To evaluate mean change in vision at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2009.
- Derived from this study: PubMed 23410808Ramaiya 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.
Related trials for Presumed Ocular Histoplasmosis (POHS)
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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.
Kevin J. Blinder, MD principal investigator
Barnes Retina Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ranibizumab and verteporfin in people with Presumed Ocular Histoplasmosis (POHS), run by Barnes Retina Institute at 2 sites 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 6 inclusion and 14 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 16 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
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 Ginny S Nobel, COT (314-367-1278 ext. 2305, bristudy@barnesretinainstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in visual acuity (time frame: 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00546936, which also lists 1 linked publication.
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 16 Apr 2009.