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Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome

Primary Purpose

Choroidal Neovascularization, Presumed Ocular Histoplasmosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EYLEA (Aflibercept) intravitreal injection
Sponsored by
Retina Research Institute, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Neovascularization

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Retina Institute
  • The Retina Institute
  • The Retina Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

IVT injection once every 8 weeks after 3 initial monthly doses

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety
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
Mean change in OCT central foveal thickness from baseline at Months 6 and 12
Mean change in Macular Volume from baseline at Months 6 and 12
Mean change in visual acuity (BCVA) from baseline at Months 6 and 12
Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12
Proportion of patients with no fluid on OCT (absence of cystic edema and subretinal fluid) at Months 6 and 12

Full Information

First Posted
April 2, 2012
Last Updated
August 27, 2018
Sponsor
Retina Research Institute, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01578720
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Retina Research Institute, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularization, Presumed Ocular Histoplasmosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVT injection once every 8 weeks after 3 initial monthly doses
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
EYLEA (Aflibercept) intravitreal injection
Intervention Description
Intravitreal Injection once every 8 weeks with 3 initial monthly doses
Primary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mean visual acuity (BCVA) at Months 6 and 12
Time Frame
Month 6 and Month 12
Title
Mean change in OCT central foveal thickness from baseline at Months 6 and 12
Time Frame
Months 6 and 12
Title
Mean change in Macular Volume from baseline at Months 6 and 12
Time Frame
Months 6 and 12
Title
Mean change in visual acuity (BCVA) from baseline at Months 6 and 12
Time Frame
Months 6 and 12
Title
Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12
Time Frame
Months 6 and 12
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin J Blinder, MD
Organizational Affiliation
The Retina Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States

12. IPD Sharing Statement

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Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome

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