Clinical trial NCT01578720: Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome
Official title: Treatment of CNV Secondary to Presumed Ocular Histoplasmosis With EYLEA 2.0mg (Intravitreal Aflibercept Injection)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Choroidal Neovascularization
Presumed Ocular Histoplasmosis
Lead sponsor: Retina Research Institute, LLC
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).


Eligibility criteria: Inclusion Criteria:

* CNV of less than 1 year duration due to presumed ocular histoplasmosis
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age 21 years and older
* Subfoveal or juxtafoveal CNV lesion of less than 5400um in diameter
* Best corrected visual acuity of 20/25 to 20/400
* Birth control therapy for females of child-bearing age

Exclusion Criteria:

* CNV due to presumed ocular histoplasmosis for greater than 1 year
* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception : surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
* A recent history of smoking (within 1 year of study enrollment)
* Prior treatment with intravitreal aflibercept injection
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Uncontrolled glaucoma in the study eye (defined as IOP greater or equal to 30 mmHg despite treatment with anti-glaucoma medication)
* History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Presence of significant subfoveal fibrosis or atrophy
* Intraocular surgery (including cataract surgery) in the study eye within 2 months of enrollment
* Active intraocular inflammation (grade trace or above) in the study eye
* History of allergy to fluorescein, ICG or iodine, not amendable to treatment
* Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either
* Require medical or surgical intervention during the 12 month study period to prevent or treat visual loss that might result from that condition, or
* If allowed to progress untreated, could likely contribute to loss of at least 2 snellen equivalent lines of BCVA over the 12 month study period
* Prior/Concomitant Treatment:
* Panretinal photocoagulation treatment
* Previous intraocular steroids or PDT within 3 months
* Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals)
* Previous treatment with intravitreally (in either eye) or intravenously administered Avastin (bevacizumab) within 60 days
* Previous use of Macugen or Lucentis in study eye within 60 days
* Prior submacular or vitreous surgery

Primary outcomes:
measure: Safety
timeFrame: 12 months
Secondary outcomes:
measure: Mean visual acuity (BCVA) at Months 6 and 12
timeFrame: Month 6 and Month 12
measure: Mean change in OCT central foveal thickness from baseline at Months 6 and 12
timeFrame: Months 6 and 12
measure: Mean change in Macular Volume from baseline at Months 6 and 12
timeFrame: Months 6 and 12
measure: Mean change in visual acuity (BCVA) from baseline at Months 6 and 12
timeFrame: Months 6 and 12
measure: Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12
timeFrame: Months 6 and 12
measure: Proportion of patients with no fluid on OCT (absence of cystic edema and subretinal fluid) at Months 6 and 12
timeFrame: Months 6 and 12
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
Study officials:
affiliation: The Retina Institute
name: Kevin J Blinder, MD
role: PRINCIPAL_INVESTIGATOR
References: