Ocular HistoplasmosisNCT00272766
Macugen for Histoplasmosis
A study testing pegaptanib sodium in people with Ocular Histoplasmosis and Choroidal Neovascularization, run by Barnes Retina Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effect on visual acuity of Macugen (pegaptanib sodium) in patients with subfoveal choroidal neovascularization (CNV) secondary to the ocular histoplasmosis syndrome (OHS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Histoplasmosis, Choroidal Neovascularization
- What is being tested?
- pegaptanib sodium
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to May 2007
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ocular histoplasmosis,
- Evidence of classic or occult choroidal neovascularization extending under the geometric center of the fovea,
- Greatest linear diameter of no greater than 5400 microns,
- Best-corrected visual acuity scores between 20/40-20/200,
- Ability to give informed consent,
- Limited child bearing potential and a negative pregnancy test
Who cannot join
- Features of any condition other than OHS such as AMD, or pathologic or myopic angioid streaks associated with CNV in the study eye,
- Area of CNV that is less than 50% of the total lesion not including area of prior laser treatment, previous rip of retinal pigment epithelium,
- Vitelliform-like lesion,
- Telangiectasia,
- Central serous retinopathy,
- Serous pigment epithelial detachment without CNV,
Show all 14Show fewer
- Any significant ocular disease other than CNV that could compromise vision in the study eye, such as amblyopia, glaucoma, optic neuropathy, or diabetic retinopathy,
- Inability to obtain photographs to document CNV,
- Presence of atrophy/scar in the center of fovea,
- Presence of vitreo-retinal traction over the center of the fovea,
- History of treatment for CNV in the study eye other than non-foveal laser photocoagulation,within 12 weeks prior to enrollment
- Participation in another clinical trial or use of another investigational new drug within 12 weeks of the full extent of the study treatment,
- Intraocular surgery within the last two months,
- Capsulectomy within the last month in the study eye
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Macugen for Histoplasmosis-An Open-Label, Single-Site, Comparative, Prospective Case Series
The purpose of this study is to evaluate the safety and effect on visual acuity of Macugen (pegaptanib sodium) in patients with subfoveal choroidal neovascularization (CNV) secondary to the ocular histoplasmosis syndrome (OHS).
Read the detailed description
Ocular histoplasmosis is a leading cause of severe and irreversible central vision loss in middle-aged adults living in the central and eastern US. OHS has been associated with the fungus Histoplasma capsulatum, a dimorphic soil mold found in 18 to 20 states in the central and eastern US. Annually, approximately 100,000 people are thought to be at risk of vision loss caused by OHS.
This study will include OHS patients with CNV lesions no larger than 5400 microns in greatest linear diameter with classic or occult CNV extending under the geometric center of the FAZ and best-corrected visual acuity letter score between 20/40-20/200. Twenty four patients will be enrolled and the study will have 2 treatment arms with 12 patients each. The first arm will consist of 12 patients who will receive 0.3 mg of Macugen intravitreally every 6 weeks for one year. The second arm will consist of 12 patients who will receive Photodynamic Therapy (PDT) with Visudyne every 3 months for one year.
- Being tested
- pegaptanib sodium
- Keywords
- Ocular histoplasmosis, Macugen, Photodynamic therapy with Visudyne, Best-corrected visual acuity scores between 20/40-20/200, classic or occult choroidal neovascularization
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegaptanib sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual function measurements, including change from baseline in visual acuity: lesion size: and leakage for one year
Secondary outcomes (1)
Patients who gain 7 or more letters or patients who lose 8 or more letters from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startFeb 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HistoplasmosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Barnes Retina Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Gaurav K Shah, MD, Principal investigator, Barnes Retina Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272766
- Sponsor's protocol ID
- 2005-0722
- Other IDs
- 05-1103
- Status last verified
- Oct 2006
- First submitted
- 4 Jan 2006
- Last updated
- 27 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macugen for Histoplasmosis-An Open-Label, Single-Site, Comparative, Prospective Case Series
- ClinicalTrials.gov ID
- NCT00272766
- Acronym / sponsor ID
- 2005-0722
- Keywords
- Ocular histoplasmosis, Macugen, Photodynamic therapy with Visudyne, Best-corrected visual acuity scores between 20/40-20/200, classic or occult choroidal neovascularization
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants
- Lead sponsor
- Barnes Retina InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2006
- Study completion
- May 2007
- First posted
- 9 Jan 2006 (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 effect on visual acuity of Macugen (pegaptanib sodium) in patients with subfoveal choroidal neovascularization (CNV) secondary to the ocular histoplasmosis syndrome (OHS).
Detailed description
Ocular histoplasmosis is a leading cause of severe and irreversible central vision loss in middle-aged adults living in the central and eastern US. OHS has been associated with the fungus Histoplasma capsulatum, a dimorphic soil mold found in 18 to 20 states in the central and eastern US. Annually, approximately 100,000 people are thought to be at risk of vision loss caused by OHS.
This study will include OHS patients with CNV lesions no larger than 5400 microns in greatest linear diameter with classic or occult CNV extending under the geometric center of the FAZ and best-corrected visual acuity letter score between 20/40-20/200. Twenty four patients will be enrolled and the study will have 2 treatment arms with 12 patients each. The first arm will consist of 12 patients who will receive 0.3 mg of Macugen intravitreally every 6 weeks for one year. The second arm will consist of 12 patients who will receive Photodynamic Therapy (PDT) with Visudyne every 3 months for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of ocular histoplasmosis,
- Evidence of classic or occult choroidal neovascularization extending under the geometric center of the fovea,
- Greatest linear diameter of no greater than 5400 microns,
- Best-corrected visual acuity scores between 20/40-20/200,
- Ability to give informed consent,
Key exclusion criteria (14 listed)
- Features of any condition other than OHS such as AMD, or pathologic or myopic angioid streaks associated with CNV in the study eye,
- Area of CNV that is less than 50% of the total lesion not including area of prior laser treatment, previous rip of retinal pigment epithelium,
- Vitelliform-like lesion,
- Telangiectasia,
- Central serous retinopathy,
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 |
|---|---|---|
| pegaptanib sodium | Drug | – |
Primary outcome
Visual function measurements, including change from baseline in visual acuity: lesion size: and leakage for one year
1 secondary outcome
Patients who gain 7 or more letters or patients who lose 8 or more letters from baseline
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2006.
Related trials for Ocular Histoplasmosis
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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.
Gaurav K Shah, MD principal investigator
Barnes Retina Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pegaptanib sodium in people with Ocular Histoplasmosis and Choroidal Neovascularization, run by Barnes Retina Institute 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 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: stopped early, as of the sponsor's last update on 27 Oct 2006. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual function measurements, including change from baseline in visual acuity: lesion size: and leakage for one year. 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 27 Oct 2006.