Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01578720
Recruitment Status : Active, not recruiting
First Posted : April 17, 2012
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):
Rhonda Weeks, Retina Research Institute, LLC

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).

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Presumed Ocular Histoplasmosis Drug: EYLEA (Aflibercept) intravitreal injection Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of CNV Secondary to Presumed Ocular Histoplasmosis With EYLEA 2.0mg (Intravitreal Aflibercept Injection)
Study Start Date : June 2012
Actual Primary Completion Date : April 2014
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Histoplasmosis

Arm Intervention/treatment
IVT injection once every 8 weeks after 3 initial monthly doses

Intravitreal aflibercept injection 2.0mg dosed every 4 weeks (monthly)for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection every eight weeks (2 months).

Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of greater than or equal to 5 letters from the previous visit.

Drug: EYLEA (Aflibercept) intravitreal injection
Intravitreal Injection once every 8 weeks with 3 initial monthly doses

Primary Outcome Measures :
  1. Safety [ Time Frame: 12 months ]
    The Incidence & Severity will be assessed during study participation. Baseline medical conditions & abnormal findings present prior to the patient signing the Informed Consent Form (ICF)will be recorded as pre-existing illnesses in the medical history. Clinical study staff will start assessing subjects for adverse events once the ICF has been signed starting at month 1 and at each monthly visit,and will be instructed to request the adverse event information in a nonspecific, non-suggestive type of questioning. The Investigators will record all adverse events regardless of causality.

Secondary Outcome Measures :
  1. Mean visual acuity (BCVA) at Months 6 and 12 [ Time Frame: Month 6 and Month 12 ]
  2. Mean change in OCT central foveal thickness from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
  3. Mean change in Macular Volume from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
  4. Mean change in visual acuity (BCVA) from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
  5. Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ]
  6. Proportion of patients with no fluid on OCT (absence of cystic edema and subretinal fluid) at Months 6 and 12 [ Time Frame: Months 6 and 12 ]

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01578720

United States, Missouri
The Retina Institute
Saint Louis, Missouri, United States, 63017
The Retina Institute
Saint Louis, Missouri, United States, 63110
The Retina Institute
Saint Louis, Missouri, United States, 63128
Sponsors and Collaborators
Retina Research Institute, LLC
Principal Investigator: Kevin J Blinder, MD The Retina Institute

Responsible Party: Rhonda Weeks, Kevin J. Blinder, MD, Retina Research Institute, LLC Identifier: NCT01578720     History of Changes
Other Study ID Numbers: KB-001
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases