Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2013-03-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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intravitreal aflibercept injection
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.
.
aflibercept
intravitreal aflibercept
Group B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months.
aflibercept
Interventions
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aflibercept
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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John Kitchens, MD
OTHER
Responsible Party
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John Kitchens, MD
Sponsor-Investigator
Principal Investigators
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John W Kitchens, MD
Role: PRINCIPAL_INVESTIGATOR
Retina Associates of Kentucky
Locations
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Southeast Retina
Augusta, Georgia, United States
Retina Associates of Kentucky
Lexington, Kentucky, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Megan Kingdon
Role: primary
Related Links
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Related Info
Other Identifiers
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IND 117497
Identifier Type: -
Identifier Source: org_study_id
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