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Trial record 2 of 35 for:    retina associates of kentucky

Treatment for Presumed Ocular Histoplasmosis (HANDLE)

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: NCT01790893
Recruitment Status : Unknown
Verified June 2014 by John Kitchens, MD, Retina Associates of Kentucky.
Recruitment status was:  Recruiting
First Posted : February 13, 2013
Last Update Posted : June 16, 2014
Information provided by (Responsible Party):
John Kitchens, MD, Retina Associates of Kentucky

Brief Summary:
The purpose of this study is to monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome.

Condition or disease Intervention/treatment Phase
Ocular Histoplasmosis Drug: aflibercept Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Aflibercept Injection for the Treatment of cHoroidAl Neovascularization seconDary to Presumed ocuLar Histoplasmosis syndromE.(the HANDLE Study)
Study Start Date : March 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Histoplasmosis

Arm Intervention/treatment
Experimental: intravitreal aflibercept injection

Group A -Monthly intravitreal aflibercept injection for 3 months (Baseline, Months 1 and 2), then mandatory every 2 months intravitreal aflibercept injection (Months 4,6, 8 and 10)for 12 months. Monthly visits with evaluations for as needed intravitreal aflibercept injection.


Drug: aflibercept
Experimental: intravitreal aflibercept
Group B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months.
Drug: aflibercept

Primary Outcome Measures :
  1. ocular and systemic adverse events [ Time Frame: through Month 12 ]
    The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12

Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: Months 3, 6, 9 and 12 ]
    • Mean change in BCVA from Baseline
    • Proportion of subjects gaining >5,10 and 15 letters
    • Proportion of subjects losing >5, 10 and 15 letters

Other Outcome Measures:
  1. OCT changes [ Time Frame: baseline to 12 months ]
    Mean change from baseline in central subfield thickness over time up to 12 months assessed on OCT

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Active choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis demonstrated by active leakage on fluorescein angiography with spectal domain OCT evidence of subretinal or intraretinal fluid or PED.
  • Active CNV may also be defined as demonstrating active subretinal hemorrhage.
  • ETDRS Best corrected visual acuity 20/20-20/320.
  • willing and able to comply with all study clinic visits and study related procedures.
  • Willing to use and practice more than one form of contraceptives during the 13 month study for male and female.
  • Provide signed informed consent
  • Able to understand and complete study related questionnaires

Exclusion Criteria:

  • Under 18 years of age
  • CNV due to other causes than Presumed Ocular Histoplasmosis
  • Previous treatment in the study eye within 6 months prior to Day 1
  • More than 5 Intravitreal injections of anti-VEGF therapy within previous 12 months
  • Any clinical evidence of any other ocular condition other than Ocular histoplasmosis
  • History of allergy to fluorescein
  • Pregnant( or planning on becoming pregnant within the next 13 months) or breast feeding women
  • Sexually Active Men or Women who are NOT willing to practice more than one form of contraceptives during the next 13 months.
  • Anticipated or previous (within previous 3 months) systemic anti-VEGF therapy

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): NCT01790893

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Contact: Diana Holcomb, COA 859-264-2905

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United States, Georgia
Southeast Retina Recruiting
Augusta, Georgia, United States, 30909
Contact: Jared Gardner    706-650-0061   
Contact: Courtney Caulder    706-650-0061   
Principal Investigator: Dennis Marcus, MD         
Sub-Investigator: Harinderjit Singh, MD         
United States, Kentucky
Retina Associates of Kentucky Recruiting
Lexington, Kentucky, United States, 40509
Contact: Diana Holcomb    859-264-2905   
Principal Investigator: John W. Kitchens, MD         
Sub-Investigator: William J Wood, MD         
Sub-Investigator: Tom Stone, MD         
Sub-Investigator: Rick Isernhagen, MD         
Sub-Investigator: Andrew Moshfeghi, MD         
United States, Ohio
Cincinnati Eye Institute Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Megan Kingdon    513-569-3669      
Principal Investigator: Daniel Miller, MD         
Sub-Investigator: Michael Petersen, MD, PhD         
Sub-Investigator: Robert Sisk, MD         
Sub-Investigator: Robert Foster, MD         
Sub-Investigator: Christopher Riemann, MD         
Sub-Investigator: Brian Toussaint, MD         
Sponsors and Collaborators
John Kitchens, MD
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Principal Investigator: John W Kitchens, MD Retina Associates of Kentucky
Additional Information:
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Responsible Party: John Kitchens, MD, Sponsor-Investigator, Retina Associates of Kentucky Identifier: NCT01790893    
Other Study ID Numbers: IND 117497
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014
Keywords provided by John Kitchens, MD, Retina Associates of Kentucky:
Additional relevant MeSH terms:
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