Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome

NCT ID: NCT01578720

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-03-31

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).

Conditions

Choroidal Neovascularization; Presumed Ocular Histoplasmosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

EYLEA (Aflibercept) intravitreal injection

Intervention Type: DRUG

Intravitreal Injection once every 8 weeks with 3 initial monthly doses

Interventions

EYLEA (Aflibercept) intravitreal injection

Intravitreal Injection once every 8 weeks with 3 initial monthly doses

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Retina Research Institute, LLC

OTHER

Sponsor Role: lead

Responsible Party

Rhonda Weeks

Kevin J. Blinder, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin J Blinder, MD

Role: PRINCIPAL_INVESTIGATOR

The Retina Institute

Locations

The Retina Institute

St Louis, Missouri, United States

The Retina Institute

St Louis, Missouri, United States

The Retina Institute

St Louis, Missouri, United States

Countries

United States

Other Identifiers

KB-001

Identifier Type: -

Identifier Source: org_study_id