Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome

NCT01578720 | Completed Phase 1

• 1 other identifier: KB-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (6)

• Mean visual acuity (BCVA) at Months 6 and 12

  Month 6 and Month 12

• Mean change in OCT central foveal thickness from baseline at Months 6 and 12

  Months 6 and 12

• Mean change in Macular Volume from baseline at Months 6 and 12

  Months 6 and 12

• Mean change in visual acuity (BCVA) from baseline at Months 6 and 12

  Months 6 and 12

• Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12

  Months 6 and 12

Study Arms (1)

IVT injection once every 8 weeks after 3 initial monthly doses

OTHER

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

Interventions

EYLEA (Aflibercept) intravitreal injection DRUG

Intravitreal Injection once every 8 weeks with 3 initial monthly doses

IVT injection once every 8 weeks after 3 initial monthly doses

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Retina Research Institute, LLC: lead

Study Sites (3)

The Retina Institute

St Louis, Missouri, 63017, United States

Location

The Retina Institute

St Louis, Missouri, 63128, United States

Location

The Retina Institute

St Louis, Missouri, 63144, United States

Location

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

aflibercept; Intravitreal Injections

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Kevin J Blinder, MD

  The Retina Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kevin J. Blinder, MD

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 17, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: March 1, 2015
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

US (3)