Ocular HistoplasmosisPhase 1/2HANDLENCT01790893
Treatment for Presumed Ocular Histoplasmosis
A Phase 1/2 study testing aflibercept in people with Ocular Histoplasmosis, run by John Kitchens, MD at 3 sites in United States.
Trial summary
The purpose of this study is to monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome. 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
- What is being tested?
- aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2013to Aug 2014
- 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
- Active choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis demonstrated by active leakage on fluorescein angiography with spectal domain OCT evidence of subretinal or intraretinal fluid or PED.
- Active CNV may also be defined as demonstrating active subretinal hemorrhage.
- ETDRS Best corrected visual acuity 20/20-20/320.
- willing and able to comply with all study clinic visits and study related procedures.
- Willing to use and practice more than one form of contraceptives during the 13 month study for male and female.
- Provide signed informed consent
- Able to understand and complete study related questionnaires
Who cannot join
- Under 18 years of age
- CNV due to other causes than Presumed Ocular Histoplasmosis
- Previous treatment in the study eye within 6 months prior to Day 1
- More than 5 Intravitreal injections of anti-VEGF therapy within previous 12 months
- Any clinical evidence of any other ocular condition other than Ocular histoplasmosis
- History of allergy to fluorescein
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- Pregnant( or planning on becoming pregnant within the next 13 months) or breast feeding women
- Sexually Active Men or Women who are NOT willing to practice more than one form of contraceptives during the next 13 months.
- Anticipated or previous (within previous 3 months) systemic anti-VEGF therapy
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Southeast Retina
Augusta, Georgia, 30909
Jared Gardner, 706-650-0061, jgardner@southeastretina.com
Courtney Caulder, 706-650-0061, ccaulder@southeastretina.com
- Recruiting
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Megan Kingdon, 513-569-3669
Daniel Miller, MD
- Recruiting
Retina Associates of Kentucky
Lexington, Kentucky, 40509
Diana Holcomb, 859-264-2905, dholcomb@retinaky.com
John W. Kitchens, MD
About this study
Official title: Intravitreal Aflibercept Injection for the Treatment of cHoroidAl Neovascularization seconDary to Presumed ocuLar Histoplasmosis syndromE.(the HANDLE Study)
The purpose of this study is to monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome.
- Conditions
- Ocular Histoplasmosis
- Being tested
- aflibercept
- 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.
afliberceptDrug
| Study group | Role | What they receive |
|---|---|---|
| intravitreal aflibercept injection | Experimental | Group A -Monthly intravitreal aflibercept injection for 3 months (Baseline, Months 1 and 2), then mandatory every 2 months intravitreal aflibercept injection (Months 4,6, 8 and 10)for 12 months. Monthly visits with evaluations for as needed intravitreal aflibercept injection.
. Receives: Drug: aflibercept |
| intravitreal aflibercept | Experimental | Group B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months. Receives: Drug: aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular and systemic adverse events
The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12
Measured: through Month 12
Secondary outcomes (1)
Visual acuity
- Mean change in BCVA from Baseline
- Proportion of subjects gaining >5,10 and 15 letters
- Proportion of subjects losing >5, 10 and 15 letters
Measured: Months 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Kitchens, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Kitchens, MD, Retina Associates of Kentucky
- Investigators
- John W Kitchens, MD, Principal investigator, Retina Associates of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790893
- Sponsor's protocol ID
- IND 117497
- Acronym
- HANDLE
- Status last verified
- Jun 2014
- First submitted
- 11 Feb 2013
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Aflibercept Injection for the Treatment of cHoroidAl Neovascularization seconDary to Presumed ocuLar Histoplasmosis syndromE.(the HANDLE Study)
- ClinicalTrials.gov ID
- NCT01790893
- Acronym / sponsor ID
- HANDLE / IND 117497
- Conditions
- Ocular Histoplasmosis
- Keywords
- Histoplasmosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- John Kitchens, MDUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 13 Feb 2013 (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 monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravitreal aflibercept injection | Experimental | Drug: afliberceptGroup A -Monthly intravitreal aflibercept injection for 3 months (Baseline, Months 1 and 2), then mandatory every 2 months intravitreal aflibercept injection (Months 4,6, 8 and 10)for 12 months. Monthly visits with evaluations for as needed intravitreal aflibercept injection. . |
| intravitreal aflibercept | Experimental | Drug: afliberceptGroup B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Active choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis demonstrated by active leakage on fluorescein angiography with spectal domain OCT evidence of subretinal or intraretinal fluid or PED.
- Active CNV may also be defined as demonstrating active subretinal hemorrhage.
- ETDRS Best corrected visual acuity 20/20-20/320.
- willing and able to comply with all study clinic visits and study related procedures.
- Willing to use and practice more than one form of contraceptives during the 13 month study for male and female.
Key exclusion criteria (9 listed)
- Under 18 years of age
- CNV due to other causes than Presumed Ocular Histoplasmosis
- Previous treatment in the study eye within 6 months prior to Day 1
- More than 5 Intravitreal injections of anti-VEGF therapy within previous 12 months
- Any clinical evidence of any other ocular condition other than Ocular histoplasmosis
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 |
|---|---|---|
| aflibercept | Drug | intravitreal aflibercept, intravitreal aflibercept injection |
Primary outcome
ocular and systemic adverse events
Time frame: through Month 12
The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12
1 secondary outcome
Visual acuity
Time frame: Months 3, 6, 9 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
- Related InfoLink provided by the sponsor.
Related trials for Ocular Histoplasmosis
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 W Kitchens, MD principal investigator
Retina Associates of Kentucky
3 sites 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 aflibercept in people with Ocular Histoplasmosis, run by John Kitchens, MD at 3 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 7 inclusion and 9 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 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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 (859-264-2905, dholcomb@retinaky.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ocular and systemic adverse events (time frame: through Month 12). 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 16 Jun 2014.