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Treatment for Presumed Ocular Histoplasmosis (HANDLE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Retina Associates of Kentucky
Sponsor:
Information provided by (Responsible Party):
John Kitchens, MD, Retina Associates of Kentucky
ClinicalTrials.gov Identifier:
NCT01790893
First received: February 11, 2013
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Ocular Histoplasmosis
Drug: aflibercept
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Retina Associates of Kentucky:

Primary Outcome Measures:
  • ocular and systemic adverse events [ Time Frame: through Month 12 ] [ Designated as safety issue: Yes ]
    The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12


Secondary Outcome Measures:
  • Visual acuity [ Time Frame: Months 3, 6, 9 and 12 ] [ Designated as safety issue: Yes ]
    • 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:
  • OCT changes [ Time Frame: baseline to 12 months ] [ Designated as safety issue: Yes ]
    Mean change from baseline in central subfield thickness over time up to 12 months assessed on OCT


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790893

Contacts
Contact: Diana Holcomb, COA 859-264-2905 dholcomb@retinaky.com

Locations
United States, Georgia
Southeast Retina Recruiting
Augusta, Georgia, United States, 30909
Contact: Jared Gardner    706-650-0061    jgardner@southeastretina.com   
Contact: Courtney Caulder    706-650-0061    ccaulder@southeastretina.com   
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    dholcomb@retinaky.com   
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
Investigators
Principal Investigator: John W Kitchens, MD Retina Associates of Kentucky
  More Information

Additional Information:
No publications provided

Responsible Party: John Kitchens, MD, Sponsor-Investigator, Retina Associates of Kentucky
ClinicalTrials.gov Identifier: NCT01790893     History of Changes
Other Study ID Numbers: IND 117497
Study First Received: February 11, 2013
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Retina Associates of Kentucky:
Histoplasmosis

Additional relevant MeSH terms:
Choroidal Neovascularization
Histoplasmosis
Choroid Diseases
Uveal Diseases
Eye Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Mycoses

ClinicalTrials.gov processed this record on September 18, 2014