Ocular Histoplasmosis
Conditions
Keywords
Histoplasmosis
Brief 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.
Interventions
DRUGaflibercept
Sponsors
John Kitchens, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ocular and systemic adverse events | through Month 12 | The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | Months 3, 6, 9 and 12 | * Mean change in BCVA from Baseline * Proportion of subjects gaining \>5,10 and 15 letters * Proportion of subjects losing \>5, 10 and 15 letters |
Other
| Measure | Time frame | Description |
|---|---|---|
| OCT changes | baseline to 12 months | Mean change from baseline in central subfield thickness over time up to 12 months assessed on OCT |
Countries
United States
Contacts
Primary ContactDiana Holcomb, COA
Outcome results
None listed