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Trial record 2 of 36 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

Tracking Information
First Submitted Date  ICMJE February 11, 2013
First Posted Date  ICMJE February 13, 2013
Last Update Posted Date June 16, 2014
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 11, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Treatment for Presumed Ocular Histoplasmosis
Official Title  ICMJE Intravitreal Aflibercept Injection for the Treatment of cHoroidAl Neovascularization seconDary to Presumed ocuLar Histoplasmosis syndromE.(the HANDLE Study)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ocular Histoplasmosis
Intervention  ICMJE Drug: aflibercept
Study Arms  ICMJE
  • 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.


    Intervention: 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.
    Intervention: Drug: aflibercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 11, 2013)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2014
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01790893
Other Study ID Numbers  ICMJE IND 117497
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Kitchens, MD, Retina Associates of Kentucky
Study Sponsor  ICMJE John Kitchens, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John W Kitchens, MD Retina Associates of Kentucky
PRS Account Retina Associates of Kentucky
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP