Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rhonda Weeks, Retina Research Institute, LLC
ClinicalTrials.gov Identifier:
NCT01578720
First received: April 2, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Choroidal Neovascularization
Presumed Ocular Histoplasmosis
Drug: EYLEA (Aflibercept) intravitreal injection
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of CNV Secondary to Presumed Ocular Histoplasmosis With EYLEA 2.0mg (Intravitreal Aflibercept Injection)

Resource links provided by NLM:


Further study details as provided by Retina Research Institute, LLC:

Primary Outcome Measures:
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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:
  • Mean visual acuity (BCVA) at Months 6 and 12 [ Time Frame: Month 6 and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean change in OCT central foveal thickness from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: Yes ]
  • Mean change in Macular Volume from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: Yes ]
  • Mean change in visual acuity (BCVA) from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: Yes ]
  • Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12 [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: June 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578720

Locations
United States, Missouri
The Retina Institute
St. Louis, Missouri, United States, 63017
The Retina Institute
St. Louis, Missouri, United States, 63128
The Retina Institute
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Retina Research Institute, LLC
Investigators
Principal Investigator: Kevin J Blinder, MD The Retina Institute
  More Information

No publications provided

Responsible Party: Rhonda Weeks, Kevin J. Blinder, MD, Retina Research Institute, LLC
ClinicalTrials.gov Identifier: NCT01578720     History of Changes
Other Study ID Numbers: KB-001
Study First Received: April 2, 2012
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014